News

The DATA2020 HealthyPeople.gov data search function just got more user friendly. The Office of Disease Prevention and Health Promotion, National Center for Health Statistics, and Office of Minority Health, partners in DATA2020, have released a shareable widget that gives users easy access to regularly updated information.

The health disparities tool at DATA2020 lets users sort and view health disparities by demographic groups, including race/ethnicity, age, disability status, and geographic location. Users also can easily navigate and visualize data and changes in disparities over time; compare data points for each population group; and see all rates, rate ratios, confidence intervals and other technical details about data collection.

The new widget is an easy way (by simply copying the provided code) to share health disparities information on individual websites. Users can browse by disparity type or by Leading Health Indicator. The widget needs no maintenance; content updates automatically.

The DATA2020 HealthyPeople.gov data search function just got more user friendly. The Office of Disease Prevention and Health Promotion, National Center for Health Statistics, and Office of Minority Health, partners in DATA2020, have released a shareable widget that gives users easy access to regularly updated information.

The health disparities tool at DATA2020 lets users sort and view health disparities by demographic groups, including race/ethnicity, age, disability status, and geographic location. Users also can easily navigate and visualize data and changes in disparities over time; compare data points for each population group; and see all rates, rate ratios, confidence intervals and other technical details about data collection.

The new widget is an easy way (by simply copying the provided code) to share health disparities information on individual websites. Users can browse by disparity type or by Leading Health Indicator. The widget needs no maintenance; content updates automatically.

The DATA2020 HealthyPeople.gov data search function just got more user friendly. The Office of Disease Prevention and Health Promotion, National Center for Health Statistics, and Office of Minority Health, partners in DATA2020, have released a shareable widget that gives users easy access to regularly updated information.

The health disparities tool at DATA2020 lets users sort and view health disparities by demographic groups, including race/ethnicity, age, disability status, and geographic location. Users also can easily navigate and visualize data and changes in disparities over time; compare data points for each population group; and see all rates, rate ratios, confidence intervals and other technical details about data collection.

The new widget is an easy way (by simply copying the provided code) to share health disparities information on individual websites. Users can browse by disparity type or by Leading Health Indicator. The widget needs no maintenance; content updates automatically.

MADRID – The biosimilar GP2013 met the criteria for therapeutic equivalence to rituximab in a large comparator trial of previously untreated patients with aggressive follicular lymphoma.

Based on results presented at the European Society for Medical Oncology Congress, “there is absolutely no difference in the objective response rates for GP2013 and rituximab,” the primary endpoint of the trial, reported Wojciech Jurczak, MD, PhD, head of lymphoma, department of hematology, Jagiellonian University, Krakow, Poland.

Dr. Jurczak characterized the double-blind, randomized phase 3 trial ASSIST_FL (NCT01419665) as the “largest biosimilar trial in hematology.” For the study, 629 patients with previously untreated, advanced-stage follicular lymphoma were randomized to GP2013 and the conventional regimen of cyclophosphamide, vincristine, and prednisone (G-CVP) or rituximab and the same three-agent regimen (R-CVP). Each regimen was given for eight cycles followed by maintenance monotherapy with the assigned monoclonal antibody for up to 2 years.

The primary endpoint, objective response rate (ORR), was 87.1% and 87.5% for G-CVP and R-CVP, respectively. There were no differences in ORR among the subgroups evaluated, which included patients aged 60 years and older vs. younger patients, presence or absence of bulky disease, high or low FLIPI (Follicular Lymphoma International Prognostic Index) score, gender, and the geographic region where treatment was given.

Safety was a secondary endpoint evaluated at the end of eight cycles and again after a year of maintenance therapy. The proportion of patients with any adverse event and the proportion with grade 3 or greater adverse events were not statistically different at any time point. There were also no significant differences in any of the other secondary endpoints evaluated, which included pharmacokinetic, pharmacodynamic, and immune measures.

The results are consistent with those of a related randomized bioequivalence trial comparing GP2013 and rituximab in 312 patients with rheumatoid arthritis (Ann Rheum Dis. 2017;76:1598-1602). The primary endpoint in that trial was area-under-the-curve serum concentration time.

The two studies are mutually reinforcing, and “the ASSIST_FL trial ends the story. We have the totality of evidence that GP2013 can be considered a biosimilar,” said Dr. Jurczak, who anticipates “major price differences” for this agent relative to rituximab.

“We may, based on the results of the follicular lymphoma trial, use the biosimilar in all registered indications for rituximab,” said Dr. Jurczak. This is also the conclusion of the European Medicine Agency, which approved this agent in June 2017 for all rituximab indications.

In explaining the process for approval of biosimilars, Dr. Jurczak emphasized that demonstrating bioequivalence is not the same as the approval process for a new therapeutic agent, for which regulatory agents require a demonstration of efficacy on a meaningful clinical endpoint, such as progression-free survival. For biosimilars, it is not necessary to show clinical benefits. Biosimilars must demonstrate the same biological activity, and ORR is considered an acceptable measure.

The ESMO-invited discussant, Michele Ghielmini, MD, PhD, medical director at the Oncology Institute of Southern Switzerland, Bellinzona, agreed. “We can reasonably speculate that (when rituximab and the biosimilar are associated with the same) response rate, they will lead to the same clinical benefits.”

MADRID – The biosimilar GP2013 met the criteria for therapeutic equivalence to rituximab in a large comparator trial of previously untreated patients with aggressive follicular lymphoma.

Based on results presented at the European Society for Medical Oncology Congress, “there is absolutely no difference in the objective response rates for GP2013 and rituximab,” the primary endpoint of the trial, reported Wojciech Jurczak, MD, PhD, head of lymphoma, department of hematology, Jagiellonian University, Krakow, Poland.

Dr. Jurczak characterized the double-blind, randomized phase 3 trial ASSIST_FL (NCT01419665) as the “largest biosimilar trial in hematology.” For the study, 629 patients with previously untreated, advanced-stage follicular lymphoma were randomized to GP2013 and the conventional regimen of cyclophosphamide, vincristine, and prednisone (G-CVP) or rituximab and the same three-agent regimen (R-CVP). Each regimen was given for eight cycles followed by maintenance monotherapy with the assigned monoclonal antibody for up to 2 years.

The primary endpoint, objective response rate (ORR), was 87.1% and 87.5% for G-CVP and R-CVP, respectively. There were no differences in ORR among the subgroups evaluated, which included patients aged 60 years and older vs. younger patients, presence or absence of bulky disease, high or low FLIPI (Follicular Lymphoma International Prognostic Index) score, gender, and the geographic region where treatment was given.

Safety was a secondary endpoint evaluated at the end of eight cycles and again after a year of maintenance therapy. The proportion of patients with any adverse event and the proportion with grade 3 or greater adverse events were not statistically different at any time point. There were also no significant differences in any of the other secondary endpoints evaluated, which included pharmacokinetic, pharmacodynamic, and immune measures.

The results are consistent with those of a related randomized bioequivalence trial comparing GP2013 and rituximab in 312 patients with rheumatoid arthritis (Ann Rheum Dis. 2017;76:1598-1602). The primary endpoint in that trial was area-under-the-curve serum concentration time.

The two studies are mutually reinforcing, and “the ASSIST_FL trial ends the story. We have the totality of evidence that GP2013 can be considered a biosimilar,” said Dr. Jurczak, who anticipates “major price differences” for this agent relative to rituximab.

“We may, based on the results of the follicular lymphoma trial, use the biosimilar in all registered indications for rituximab,” said Dr. Jurczak. This is also the conclusion of the European Medicine Agency, which approved this agent in June 2017 for all rituximab indications.

In explaining the process for approval of biosimilars, Dr. Jurczak emphasized that demonstrating bioequivalence is not the same as the approval process for a new therapeutic agent, for which regulatory agents require a demonstration of efficacy on a meaningful clinical endpoint, such as progression-free survival. For biosimilars, it is not necessary to show clinical benefits. Biosimilars must demonstrate the same biological activity, and ORR is considered an acceptable measure.

The ESMO-invited discussant, Michele Ghielmini, MD, PhD, medical director at the Oncology Institute of Southern Switzerland, Bellinzona, agreed. “We can reasonably speculate that (when rituximab and the biosimilar are associated with the same) response rate, they will lead to the same clinical benefits.”

MADRID – The biosimilar GP2013 met the criteria for therapeutic equivalence to rituximab in a large comparator trial of previously untreated patients with aggressive follicular lymphoma.

Based on results presented at the European Society for Medical Oncology Congress, “there is absolutely no difference in the objective response rates for GP2013 and rituximab,” the primary endpoint of the trial, reported Wojciech Jurczak, MD, PhD, head of lymphoma, department of hematology, Jagiellonian University, Krakow, Poland.

Dr. Jurczak characterized the double-blind, randomized phase 3 trial ASSIST_FL (NCT01419665) as the “largest biosimilar trial in hematology.” For the study, 629 patients with previously untreated, advanced-stage follicular lymphoma were randomized to GP2013 and the conventional regimen of cyclophosphamide, vincristine, and prednisone (G-CVP) or rituximab and the same three-agent regimen (R-CVP). Each regimen was given for eight cycles followed by maintenance monotherapy with the assigned monoclonal antibody for up to 2 years.

The primary endpoint, objective response rate (ORR), was 87.1% and 87.5% for G-CVP and R-CVP, respectively. There were no differences in ORR among the subgroups evaluated, which included patients aged 60 years and older vs. younger patients, presence or absence of bulky disease, high or low FLIPI (Follicular Lymphoma International Prognostic Index) score, gender, and the geographic region where treatment was given.

Safety was a secondary endpoint evaluated at the end of eight cycles and again after a year of maintenance therapy. The proportion of patients with any adverse event and the proportion with grade 3 or greater adverse events were not statistically different at any time point. There were also no significant differences in any of the other secondary endpoints evaluated, which included pharmacokinetic, pharmacodynamic, and immune measures.

The results are consistent with those of a related randomized bioequivalence trial comparing GP2013 and rituximab in 312 patients with rheumatoid arthritis (Ann Rheum Dis. 2017;76:1598-1602). The primary endpoint in that trial was area-under-the-curve serum concentration time.

The two studies are mutually reinforcing, and “the ASSIST_FL trial ends the story. We have the totality of evidence that GP2013 can be considered a biosimilar,” said Dr. Jurczak, who anticipates “major price differences” for this agent relative to rituximab.

“We may, based on the results of the follicular lymphoma trial, use the biosimilar in all registered indications for rituximab,” said Dr. Jurczak. This is also the conclusion of the European Medicine Agency, which approved this agent in June 2017 for all rituximab indications.

In explaining the process for approval of biosimilars, Dr. Jurczak emphasized that demonstrating bioequivalence is not the same as the approval process for a new therapeutic agent, for which regulatory agents require a demonstration of efficacy on a meaningful clinical endpoint, such as progression-free survival. For biosimilars, it is not necessary to show clinical benefits. Biosimilars must demonstrate the same biological activity, and ORR is considered an acceptable measure.

The ESMO-invited discussant, Michele Ghielmini, MD, PhD, medical director at the Oncology Institute of Southern Switzerland, Bellinzona, agreed. “We can reasonably speculate that (when rituximab and the biosimilar are associated with the same) response rate, they will lead to the same clinical benefits.”

Between 2010 and 2015, the number of adults with active epilepsy rose from 2.3 million to 3 million, according to the CDC. The number of children with epilepsy rose from 450,000 to 470,000.

The increases are likely due to population growth, the CDC says, or other unknown factors, such as an increased willingness to disclose. However, most states do not have data on epilepsy prevalence. This is the first time estimates have been modeled for every state. Moreover, epilepsy has been assessed only intermittently in population surveys. Before 2010, the last national estimates were based on 1986-1990 data.

Obviously, epilepsy is not rare. It also is a serious public health issue. People with epilepsy often have other conditions, such as stroke, heart disease, depression, or developmental delay, which complicate epilepsy management, impair quality of life, and contribute to early mortality, the CDC says. Epilepsy also is the costliest and second most common of 5 chronic conditions that have adverse impact on academic and health outcomes in children and adolescents. For instance, children with seizures are more likely to live in poverty, and their parents more frequently report food insecurity.

The CDC suggests that health care providers and others can use the findings to ensure that evidence-based programs meet the complex needs of adults and children living with epilepsy and reduce the disparities resulting from it.

Between 2010 and 2015, the number of adults with active epilepsy rose from 2.3 million to 3 million, according to the CDC. The number of children with epilepsy rose from 450,000 to 470,000.

The increases are likely due to population growth, the CDC says, or other unknown factors, such as an increased willingness to disclose. However, most states do not have data on epilepsy prevalence. This is the first time estimates have been modeled for every state. Moreover, epilepsy has been assessed only intermittently in population surveys. Before 2010, the last national estimates were based on 1986-1990 data.

Obviously, epilepsy is not rare. It also is a serious public health issue. People with epilepsy often have other conditions, such as stroke, heart disease, depression, or developmental delay, which complicate epilepsy management, impair quality of life, and contribute to early mortality, the CDC says. Epilepsy also is the costliest and second most common of 5 chronic conditions that have adverse impact on academic and health outcomes in children and adolescents. For instance, children with seizures are more likely to live in poverty, and their parents more frequently report food insecurity.

The CDC suggests that health care providers and others can use the findings to ensure that evidence-based programs meet the complex needs of adults and children living with epilepsy and reduce the disparities resulting from it.

Between 2010 and 2015, the number of adults with active epilepsy rose from 2.3 million to 3 million, according to the CDC. The number of children with epilepsy rose from 450,000 to 470,000.

The increases are likely due to population growth, the CDC says, or other unknown factors, such as an increased willingness to disclose. However, most states do not have data on epilepsy prevalence. This is the first time estimates have been modeled for every state. Moreover, epilepsy has been assessed only intermittently in population surveys. Before 2010, the last national estimates were based on 1986-1990 data.

Obviously, epilepsy is not rare. It also is a serious public health issue. People with epilepsy often have other conditions, such as stroke, heart disease, depression, or developmental delay, which complicate epilepsy management, impair quality of life, and contribute to early mortality, the CDC says. Epilepsy also is the costliest and second most common of 5 chronic conditions that have adverse impact on academic and health outcomes in children and adolescents. For instance, children with seizures are more likely to live in poverty, and their parents more frequently report food insecurity.

The CDC suggests that health care providers and others can use the findings to ensure that evidence-based programs meet the complex needs of adults and children living with epilepsy and reduce the disparities resulting from it.

The CDC plans to award more than $12 million to 20 states and the District of Columbia to support responses to the opioid overdose epidemic. The new funding brings the number of recipients to 32.

States can use the funds to report nonfatal and fatal opioid overdose and risk factors linked to fatal overdoses more quickly, share data with key stakeholders, and share data with the CDC to improve multistate surveillance and response.

Fourteen states currently get funding under the Prescription Drug Overdose: Prevention for States (PfS) program, and another 8 will get $4.8 million. The money will allow states to enhance prescription drug-monitoring programs and implement and evaluate strategies to improve safe opioid prescribing practices.

The CDC plans to award more than $12 million to 20 states and the District of Columbia to support responses to the opioid overdose epidemic. The new funding brings the number of recipients to 32.

States can use the funds to report nonfatal and fatal opioid overdose and risk factors linked to fatal overdoses more quickly, share data with key stakeholders, and share data with the CDC to improve multistate surveillance and response.

Fourteen states currently get funding under the Prescription Drug Overdose: Prevention for States (PfS) program, and another 8 will get $4.8 million. The money will allow states to enhance prescription drug-monitoring programs and implement and evaluate strategies to improve safe opioid prescribing practices.

The CDC plans to award more than $12 million to 20 states and the District of Columbia to support responses to the opioid overdose epidemic. The new funding brings the number of recipients to 32.

States can use the funds to report nonfatal and fatal opioid overdose and risk factors linked to fatal overdoses more quickly, share data with key stakeholders, and share data with the CDC to improve multistate surveillance and response.

Fourteen states currently get funding under the Prescription Drug Overdose: Prevention for States (PfS) program, and another 8 will get $4.8 million. The money will allow states to enhance prescription drug-monitoring programs and implement and evaluate strategies to improve safe opioid prescribing practices.

The frequency of respiratory infections in the first 2 years of life could distinguish children who will develop celiac disease (CD) from those who will not in those with a family history of CD, according to Renata Auricchio, MD, University of Naples (Italy) Federico II, and her associates.

In a prospective cohort study, 373 newborns from families with at least one relative with CD were recruited. The cumulative incidence of new cases of CD was 6% at 3 years and 13.5% at 5 years of age, the researchers noted. In the first year when no child produced anti-tissue transglutaminase (anti-tTG) antibodies, respiratory infections (upper and lower tract) were more common among the case patients than among the controls (58% vs. 40%). During the second year, respiratory infections were again more frequent among the case patients than among controls (52% vs. 32%). And in the third year of life when most of the case patients were diagnosed with CD, no clinical event was more frequent in the case patients than in the control group.

designer491/Thinkstock

llaubach@frontlinemedcom.com

The frequency of respiratory infections in the first 2 years of life could distinguish children who will develop celiac disease (CD) from those who will not in those with a family history of CD, according to Renata Auricchio, MD, University of Naples (Italy) Federico II, and her associates.

In a prospective cohort study, 373 newborns from families with at least one relative with CD were recruited. The cumulative incidence of new cases of CD was 6% at 3 years and 13.5% at 5 years of age, the researchers noted. In the first year when no child produced anti-tissue transglutaminase (anti-tTG) antibodies, respiratory infections (upper and lower tract) were more common among the case patients than among the controls (58% vs. 40%). During the second year, respiratory infections were again more frequent among the case patients than among controls (52% vs. 32%). And in the third year of life when most of the case patients were diagnosed with CD, no clinical event was more frequent in the case patients than in the control group.

designer491/Thinkstock

llaubach@frontlinemedcom.com

The frequency of respiratory infections in the first 2 years of life could distinguish children who will develop celiac disease (CD) from those who will not in those with a family history of CD, according to Renata Auricchio, MD, University of Naples (Italy) Federico II, and her associates.

In a prospective cohort study, 373 newborns from families with at least one relative with CD were recruited. The cumulative incidence of new cases of CD was 6% at 3 years and 13.5% at 5 years of age, the researchers noted. In the first year when no child produced anti-tissue transglutaminase (anti-tTG) antibodies, respiratory infections (upper and lower tract) were more common among the case patients than among the controls (58% vs. 40%). During the second year, respiratory infections were again more frequent among the case patients than among controls (52% vs. 32%). And in the third year of life when most of the case patients were diagnosed with CD, no clinical event was more frequent in the case patients than in the control group.

designer491/Thinkstock

llaubach@frontlinemedcom.com

“Encouraging” results from a study with an experimental drug offer hope to patients with Niemann-Pick disease type C1 (NPC1), a fatal neurologic disease that affects children and adolescents.

Symptoms of NPC1 result from cholesterol building in brain cells. The drug VTS-270 showed signs of improving cholesterol metabolism in neurons. After treatment, a molecule derived from cholesterol metabolism in neurons had increased, and 2 proteins indicative of brain injury had decreased.

In a phase 1/2a clinical trial, 14 participants received the experimental drug once a month for 12 to 18 months. Another 3 participants received the drug every 2 weeks for 18 months. After observing that the drug was safe and well tolerated, the researchers increased dosing for all participants. Their progress was compared with that of 21 participants in a previous study of NPC1.

The researchers also evaluated the drug’s effectiveness using a neurologic severity score (higher scores indicated more severe disease effects). Participants treated with VTS-270 had lower scores in cognition, speech, and mobility, indicating that the drug can stabilize or slow disease progression.

No one was observed to have serious adverse outcomes, but earlier studies had shown that the treatment carries the risk for hearing loss. After treatment in this study, participants, most of whom had already lost some hearing due to the disease, had further loss, for which they compensated with hearing aids.

“Encouraging” results from a study with an experimental drug offer hope to patients with Niemann-Pick disease type C1 (NPC1), a fatal neurologic disease that affects children and adolescents.

Symptoms of NPC1 result from cholesterol building in brain cells. The drug VTS-270 showed signs of improving cholesterol metabolism in neurons. After treatment, a molecule derived from cholesterol metabolism in neurons had increased, and 2 proteins indicative of brain injury had decreased.

In a phase 1/2a clinical trial, 14 participants received the experimental drug once a month for 12 to 18 months. Another 3 participants received the drug every 2 weeks for 18 months. After observing that the drug was safe and well tolerated, the researchers increased dosing for all participants. Their progress was compared with that of 21 participants in a previous study of NPC1.

The researchers also evaluated the drug’s effectiveness using a neurologic severity score (higher scores indicated more severe disease effects). Participants treated with VTS-270 had lower scores in cognition, speech, and mobility, indicating that the drug can stabilize or slow disease progression.

No one was observed to have serious adverse outcomes, but earlier studies had shown that the treatment carries the risk for hearing loss. After treatment in this study, participants, most of whom had already lost some hearing due to the disease, had further loss, for which they compensated with hearing aids.

“Encouraging” results from a study with an experimental drug offer hope to patients with Niemann-Pick disease type C1 (NPC1), a fatal neurologic disease that affects children and adolescents.

Symptoms of NPC1 result from cholesterol building in brain cells. The drug VTS-270 showed signs of improving cholesterol metabolism in neurons. After treatment, a molecule derived from cholesterol metabolism in neurons had increased, and 2 proteins indicative of brain injury had decreased.

In a phase 1/2a clinical trial, 14 participants received the experimental drug once a month for 12 to 18 months. Another 3 participants received the drug every 2 weeks for 18 months. After observing that the drug was safe and well tolerated, the researchers increased dosing for all participants. Their progress was compared with that of 21 participants in a previous study of NPC1.

The researchers also evaluated the drug’s effectiveness using a neurologic severity score (higher scores indicated more severe disease effects). Participants treated with VTS-270 had lower scores in cognition, speech, and mobility, indicating that the drug can stabilize or slow disease progression.

No one was observed to have serious adverse outcomes, but earlier studies had shown that the treatment carries the risk for hearing loss. After treatment in this study, participants, most of whom had already lost some hearing due to the disease, had further loss, for which they compensated with hearing aids.

The FDA has approved Besponsa (inotuzumab ozogamicin) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer affecting about 6,000 people each year. About 1 in 4 patients affected will die of the disease. 

Inotuzumab ozogamicin is a targeted therapy “thought to work” by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells. In a study of 326 patients with relapsed or refractory B-cell ALL who had received 1 or 2 prior treatments, 36% of 218 evaluated patients experienced complete remission for a median 8 months. Of the patients who received alternative chemotherapy, 17% experienced complete remission for a median 5 months.

A second drug, Vyxeos ( daunorubicin and cytarabine) liposome injection, is approved for adults with 2 types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

An estimated 8% to 10% of patients with AML develop t-AML as a complication of chemotherapy or radiation. AML-MRC is characterized by a history of certain blood disorders and other significant mutations within cancer cells. Patients with either disease have a low life expectancy. Vyxeos is a fixed-combination of daunorubicin and cytarabine. It’s the first approved treatment specifically for these patients, says Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence.

In a study of 309 patients with newly diagnosed t-AML or AML-MRC, those in the Vyxeos group lived longer: median survival, 9.56 months vs. 5.95 months in the patients who received separate treatments with daunorubicin and cytarabine.The third drug, Idhifa (enasidenib), is approved for adults with relapsed or refractory AML who have a mutation in the IDH2 gene. Idhifa is an isocitrate dehydrogenase-2 inhibitor that blocks several enzymes that promote cell growth.

The drug was studied in a single-arm trial of 199 patients. With a minimum of 6 months of treatment, 19% of patients experienced complete remission for a median of 8.2 months; 4% experienced complete remission with partial hematologic recovery for a median 9.6 months. Of the 157 patients who required blood or platelet transfusions due to AML at the start of the study, 34% no longer did after treatment with Idhifa.

Idhifa is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect mutations in the IDH2 gene in blood or bone marrow.

Source:

FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 17,2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572131.htm. Accessed August 31, 2017.

FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 1, 2017. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm569421.htm. Accessed August 31, 2017.

FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm. Accessed August 31, 2017.

The FDA has approved Besponsa (inotuzumab ozogamicin) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer affecting about 6,000 people each year. About 1 in 4 patients affected will die of the disease. 

Inotuzumab ozogamicin is a targeted therapy “thought to work” by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells. In a study of 326 patients with relapsed or refractory B-cell ALL who had received 1 or 2 prior treatments, 36% of 218 evaluated patients experienced complete remission for a median 8 months. Of the patients who received alternative chemotherapy, 17% experienced complete remission for a median 5 months.

A second drug, Vyxeos ( daunorubicin and cytarabine) liposome injection, is approved for adults with 2 types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

An estimated 8% to 10% of patients with AML develop t-AML as a complication of chemotherapy or radiation. AML-MRC is characterized by a history of certain blood disorders and other significant mutations within cancer cells. Patients with either disease have a low life expectancy. Vyxeos is a fixed-combination of daunorubicin and cytarabine. It’s the first approved treatment specifically for these patients, says Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence.

In a study of 309 patients with newly diagnosed t-AML or AML-MRC, those in the Vyxeos group lived longer: median survival, 9.56 months vs. 5.95 months in the patients who received separate treatments with daunorubicin and cytarabine.The third drug, Idhifa (enasidenib), is approved for adults with relapsed or refractory AML who have a mutation in the IDH2 gene. Idhifa is an isocitrate dehydrogenase-2 inhibitor that blocks several enzymes that promote cell growth.

The drug was studied in a single-arm trial of 199 patients. With a minimum of 6 months of treatment, 19% of patients experienced complete remission for a median of 8.2 months; 4% experienced complete remission with partial hematologic recovery for a median 9.6 months. Of the 157 patients who required blood or platelet transfusions due to AML at the start of the study, 34% no longer did after treatment with Idhifa.

Idhifa is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect mutations in the IDH2 gene in blood or bone marrow.

Source:

FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 17,2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572131.htm. Accessed August 31, 2017.

FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 1, 2017. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm569421.htm. Accessed August 31, 2017.

FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm. Accessed August 31, 2017.

The FDA has approved Besponsa (inotuzumab ozogamicin) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer affecting about 6,000 people each year. About 1 in 4 patients affected will die of the disease. 

Inotuzumab ozogamicin is a targeted therapy “thought to work” by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells. In a study of 326 patients with relapsed or refractory B-cell ALL who had received 1 or 2 prior treatments, 36% of 218 evaluated patients experienced complete remission for a median 8 months. Of the patients who received alternative chemotherapy, 17% experienced complete remission for a median 5 months.

A second drug, Vyxeos ( daunorubicin and cytarabine) liposome injection, is approved for adults with 2 types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

An estimated 8% to 10% of patients with AML develop t-AML as a complication of chemotherapy or radiation. AML-MRC is characterized by a history of certain blood disorders and other significant mutations within cancer cells. Patients with either disease have a low life expectancy. Vyxeos is a fixed-combination of daunorubicin and cytarabine. It’s the first approved treatment specifically for these patients, says Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence.

In a study of 309 patients with newly diagnosed t-AML or AML-MRC, those in the Vyxeos group lived longer: median survival, 9.56 months vs. 5.95 months in the patients who received separate treatments with daunorubicin and cytarabine.The third drug, Idhifa (enasidenib), is approved for adults with relapsed or refractory AML who have a mutation in the IDH2 gene. Idhifa is an isocitrate dehydrogenase-2 inhibitor that blocks several enzymes that promote cell growth.

The drug was studied in a single-arm trial of 199 patients. With a minimum of 6 months of treatment, 19% of patients experienced complete remission for a median of 8.2 months; 4% experienced complete remission with partial hematologic recovery for a median 9.6 months. Of the 157 patients who required blood or platelet transfusions due to AML at the start of the study, 34% no longer did after treatment with Idhifa.

Idhifa is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect mutations in the IDH2 gene in blood or bone marrow.

Source:

FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 17,2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572131.htm. Accessed August 31, 2017.

FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 1, 2017. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm569421.htm. Accessed August 31, 2017.

FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia [news release]. Silver Spring, MD: U.S. Food & Drug Administration; August 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm. Accessed August 31, 2017.

Cardiovascular risk factors, such as diabetes and high blood pressure, increase the risk of dementia. That is not new information, but a long-term funded study by the National Institutes of Health found that not only is diabetes almost as strong a predictor of dementia as the APOE4 gene, but also prehypertension.

The researchers analyzed data on 15,744 participants aged 45 to 64 years in the Atherosclerosis Risk in Communities (ARIC) study. Over 25 years, the participants were examined 4 times, including being given cognitive tests during all but the first and third exams.

Over an average of 23 follow-up years, 1,516 people were diagnosed with dementia. During the time of the first exams, the risk of dementia increased most strongly with age, followed by the presence of APOE4. But as time went on, the link between cardiovascular risk factors and dementia became clearer. A separate study of an ARIC subgroup found that the presence of ≥ 1 vascular risk factor during midlife was associated with higher levels of beta amyloid, a protein that often accumulates in the brains of Alzheimer patients. The relationship was not affected by the presence of the APOE4 gene.

When the researchers reanalyzed the data according to who had a stroke, they found similar results: Diabetes, hypertension, prehypertension, and smoking raised the risk of dementia for people who had a stroke and those who had not.

“Our results contribute to a growing body of evidence linking midlife vascular health to dementia,” said study leader Rebecca Gottesman, MD, PhD, professor of neurology at Johns Hopkins University in Maryland. “These are modifiable risk factors. Our hope is that by addressing these types of factors early, people can reduce the chances that they will suffer from dementia later in life.”

Cardiovascular risk factors, such as diabetes and high blood pressure, increase the risk of dementia. That is not new information, but a long-term funded study by the National Institutes of Health found that not only is diabetes almost as strong a predictor of dementia as the APOE4 gene, but also prehypertension.

The researchers analyzed data on 15,744 participants aged 45 to 64 years in the Atherosclerosis Risk in Communities (ARIC) study. Over 25 years, the participants were examined 4 times, including being given cognitive tests during all but the first and third exams.

Over an average of 23 follow-up years, 1,516 people were diagnosed with dementia. During the time of the first exams, the risk of dementia increased most strongly with age, followed by the presence of APOE4. But as time went on, the link between cardiovascular risk factors and dementia became clearer. A separate study of an ARIC subgroup found that the presence of ≥ 1 vascular risk factor during midlife was associated with higher levels of beta amyloid, a protein that often accumulates in the brains of Alzheimer patients. The relationship was not affected by the presence of the APOE4 gene.

When the researchers reanalyzed the data according to who had a stroke, they found similar results: Diabetes, hypertension, prehypertension, and smoking raised the risk of dementia for people who had a stroke and those who had not.

“Our results contribute to a growing body of evidence linking midlife vascular health to dementia,” said study leader Rebecca Gottesman, MD, PhD, professor of neurology at Johns Hopkins University in Maryland. “These are modifiable risk factors. Our hope is that by addressing these types of factors early, people can reduce the chances that they will suffer from dementia later in life.”

Cardiovascular risk factors, such as diabetes and high blood pressure, increase the risk of dementia. That is not new information, but a long-term funded study by the National Institutes of Health found that not only is diabetes almost as strong a predictor of dementia as the APOE4 gene, but also prehypertension.

The researchers analyzed data on 15,744 participants aged 45 to 64 years in the Atherosclerosis Risk in Communities (ARIC) study. Over 25 years, the participants were examined 4 times, including being given cognitive tests during all but the first and third exams.

Over an average of 23 follow-up years, 1,516 people were diagnosed with dementia. During the time of the first exams, the risk of dementia increased most strongly with age, followed by the presence of APOE4. But as time went on, the link between cardiovascular risk factors and dementia became clearer. A separate study of an ARIC subgroup found that the presence of ≥ 1 vascular risk factor during midlife was associated with higher levels of beta amyloid, a protein that often accumulates in the brains of Alzheimer patients. The relationship was not affected by the presence of the APOE4 gene.

When the researchers reanalyzed the data according to who had a stroke, they found similar results: Diabetes, hypertension, prehypertension, and smoking raised the risk of dementia for people who had a stroke and those who had not.

“Our results contribute to a growing body of evidence linking midlife vascular health to dementia,” said study leader Rebecca Gottesman, MD, PhD, professor of neurology at Johns Hopkins University in Maryland. “These are modifiable risk factors. Our hope is that by addressing these types of factors early, people can reduce the chances that they will suffer from dementia later in life.”

What is “trauma-informed care?” Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, the Administration for Children and Families, and the Administration for Community Living, have put together a guide to explain what it is and why understanding and addressing trauma is important for human services programs. The guide is based on SAMHSA’s definition of a trauma-informed program, organization, or system: Realizing the widespread impact of trauma; recognizing signs and symptoms; responding by fulling integrating knowledge about trauma into policies, procedures, and practices; and seeking to “actively resist re-traumatization.”

The Guide to Trauma-Informed Human Services is a web-linked compilation of resources from a range of HHS agencies, federal partners and respected nongovernmental sources. The site will contain information and resources for leaders at the state, tribal, territorial, and local levels on recent advances in understanding of trauma, toxic stress, and resiliency. The topics include PTSD, how exposure to trauma affects brain development, and how adverse childhood experiences differ from trauma experienced at other times in life.

“We hope it will be both immediately helpful,” the authors say, “and a ‘living’ document to be updated over time as our knowledge and experience grow.”

What is “trauma-informed care?” Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, the Administration for Children and Families, and the Administration for Community Living, have put together a guide to explain what it is and why understanding and addressing trauma is important for human services programs. The guide is based on SAMHSA’s definition of a trauma-informed program, organization, or system: Realizing the widespread impact of trauma; recognizing signs and symptoms; responding by fulling integrating knowledge about trauma into policies, procedures, and practices; and seeking to “actively resist re-traumatization.”

The Guide to Trauma-Informed Human Services is a web-linked compilation of resources from a range of HHS agencies, federal partners and respected nongovernmental sources. The site will contain information and resources for leaders at the state, tribal, territorial, and local levels on recent advances in understanding of trauma, toxic stress, and resiliency. The topics include PTSD, how exposure to trauma affects brain development, and how adverse childhood experiences differ from trauma experienced at other times in life.

“We hope it will be both immediately helpful,” the authors say, “and a ‘living’ document to be updated over time as our knowledge and experience grow.”

What is “trauma-informed care?” Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, the Administration for Children and Families, and the Administration for Community Living, have put together a guide to explain what it is and why understanding and addressing trauma is important for human services programs. The guide is based on SAMHSA’s definition of a trauma-informed program, organization, or system: Realizing the widespread impact of trauma; recognizing signs and symptoms; responding by fulling integrating knowledge about trauma into policies, procedures, and practices; and seeking to “actively resist re-traumatization.”

The Guide to Trauma-Informed Human Services is a web-linked compilation of resources from a range of HHS agencies, federal partners and respected nongovernmental sources. The site will contain information and resources for leaders at the state, tribal, territorial, and local levels on recent advances in understanding of trauma, toxic stress, and resiliency. The topics include PTSD, how exposure to trauma affects brain development, and how adverse childhood experiences differ from trauma experienced at other times in life.

“We hope it will be both immediately helpful,” the authors say, “and a ‘living’ document to be updated over time as our knowledge and experience grow.”

Following the directive of the “Military Service by Transgender Individuals” Presidential Memorandum to reinstitute a ban on service for transgender service members, the Secretary of Defense has called for a new study of the impact of transgender service members on “military readiness, lethality, and unit cohesion, with due regard for budgetary constraints and consistent with applicable law.” Secretary of Defense Jim Mattis announced that he will “establish a panel of experts serving within the Departments of Defense and Homeland Security to provide advice and recommendations on the implementation of the president’s direction.”

The study follows on the heels of a July 2016 study issued by the RAND Corporation, which found that there are between 1,300 to 6,600 transgender active duty service members. According to the study, the “costs of gender transition-related health care are relatively low” and they had a “minimal” impact on force readiness.

The new study is due to President Trump by February 21, 2018 and is required to include a plan for implementing the ban. The potential ban on transgender service members is still set to go into effect March 23, 2018. However, there is some disagreement over whether the Presidential Memorandum leave the DoD with latitude to protect currently serving transgender service members or not.

The expected health care costs associated with transgender service members remains a significant factor in the policy decision. The RAND study estimated that health care costs would increase by between $2.4 million and $8.4 million annually with transgender service members out of an estimated $6.2 billion spent on active component health care spending, which would represent a 0.04% to 0.13% of the budget.

Following the directive of the “Military Service by Transgender Individuals” Presidential Memorandum to reinstitute a ban on service for transgender service members, the Secretary of Defense has called for a new study of the impact of transgender service members on “military readiness, lethality, and unit cohesion, with due regard for budgetary constraints and consistent with applicable law.” Secretary of Defense Jim Mattis announced that he will “establish a panel of experts serving within the Departments of Defense and Homeland Security to provide advice and recommendations on the implementation of the president’s direction.”

The study follows on the heels of a July 2016 study issued by the RAND Corporation, which found that there are between 1,300 to 6,600 transgender active duty service members. According to the study, the “costs of gender transition-related health care are relatively low” and they had a “minimal” impact on force readiness.

The new study is due to President Trump by February 21, 2018 and is required to include a plan for implementing the ban. The potential ban on transgender service members is still set to go into effect March 23, 2018. However, there is some disagreement over whether the Presidential Memorandum leave the DoD with latitude to protect currently serving transgender service members or not.

The expected health care costs associated with transgender service members remains a significant factor in the policy decision. The RAND study estimated that health care costs would increase by between $2.4 million and $8.4 million annually with transgender service members out of an estimated $6.2 billion spent on active component health care spending, which would represent a 0.04% to 0.13% of the budget.

Following the directive of the “Military Service by Transgender Individuals” Presidential Memorandum to reinstitute a ban on service for transgender service members, the Secretary of Defense has called for a new study of the impact of transgender service members on “military readiness, lethality, and unit cohesion, with due regard for budgetary constraints and consistent with applicable law.” Secretary of Defense Jim Mattis announced that he will “establish a panel of experts serving within the Departments of Defense and Homeland Security to provide advice and recommendations on the implementation of the president’s direction.”

The study follows on the heels of a July 2016 study issued by the RAND Corporation, which found that there are between 1,300 to 6,600 transgender active duty service members. According to the study, the “costs of gender transition-related health care are relatively low” and they had a “minimal” impact on force readiness.

The new study is due to President Trump by February 21, 2018 and is required to include a plan for implementing the ban. The potential ban on transgender service members is still set to go into effect March 23, 2018. However, there is some disagreement over whether the Presidential Memorandum leave the DoD with latitude to protect currently serving transgender service members or not.

The expected health care costs associated with transgender service members remains a significant factor in the policy decision. The RAND study estimated that health care costs would increase by between $2.4 million and $8.4 million annually with transgender service members out of an estimated $6.2 billion spent on active component health care spending, which would represent a 0.04% to 0.13% of the budget.