User login
FDA clears Abbott’s Influenza A & B 2, Strep A 2 assays
The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.
The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.
The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.
“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.
Find the full press release on the Abbott Laboratories website.
The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.
The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.
The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.
“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.
Find the full press release on the Abbott Laboratories website.
The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.
The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.
The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.
“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.
Find the full press release on the Abbott Laboratories website.
ACIP votes unanimously in favor of immunization schedule update and redesign
Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.
In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.
In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.
The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.
The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.
The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.
The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.
Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.
Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.
The ACIP committee members had no relevant financial conflicts to disclose.
Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.
In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.
In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.
The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.
The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.
The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.
The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.
Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.
Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.
The ACIP committee members had no relevant financial conflicts to disclose.
Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.
In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.
In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.
The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.
The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.
The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.
The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.
Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.
Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.
The ACIP committee members had no relevant financial conflicts to disclose.
AT AN ACIP MEETING
ACIP supports hepatitis A vaccine for homeless individuals
Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.
Even limited vaccination will increase the herd immunity of the homeless population over time, she said.
Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.
If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.
The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.
“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.
The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”
The ACIP committee members had no financial conflicts to disclose.
Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.
Even limited vaccination will increase the herd immunity of the homeless population over time, she said.
Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.
If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.
The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.
“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.
The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”
The ACIP committee members had no financial conflicts to disclose.
Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.
Even limited vaccination will increase the herd immunity of the homeless population over time, she said.
Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.
If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.
The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.
“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.
The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”
The ACIP committee members had no financial conflicts to disclose.
FROM AN ACIP MEETING
FDA approves Xofluza for treatment of influenza
The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.
The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.
“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The most common adverse events associated with Xofluza were diarrhea and bronchitis.
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”
Find the full press release on the FDA website.
The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.
The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.
“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The most common adverse events associated with Xofluza were diarrhea and bronchitis.
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”
Find the full press release on the FDA website.
The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.
The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.
“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The most common adverse events associated with Xofluza were diarrhea and bronchitis.
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”
Find the full press release on the FDA website.
Quadrivalent flu vaccine okayed for 6 months and up
The expanded approval now includes persons aged 6-59 months; the quadrivalent vaccine had previously been approved for ages 5 years and up. A trivalent version of the Afluria influenza vaccine also now is indicated for people aged 6 months and up, according to an Oct. 4 communication from the FDA.
A total of 172 pediatric influenza-related deaths occurred in the United States during the 2017-2018 season, representing a new high in nonpandemic influenza seasons. About half of the pediatric influenza deaths occurred in otherwise healthy children, and about 22% of children who died were fully vaccinated, according to the Centers for Disease Control and Prevention, reporting U.S. data from 2010 to 2016.
“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” Seqirus’ vice president of medical affairs Gregg Sylvester, MD, said in a press release announcing the extended indication. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”
According to the CDC, the 2018-2019 influenza vaccine has been updated to provide a better match – and more protection against – viruses circulating in this influenza season. Specifically, says the CDC, the influenza B Victoria lineage and the influenza A(H3N2) components were updated.
In addition to providing protection against these two strains of influenza, trivalent vaccines for the 2018-2019 season are recommended to include protection against H1N1 influenza as well. Quadrivalent vaccines protect against a second influenza B lineage.
Most people will receive a quadrivalent vaccine this year, according to the CDC.
The expanded approval now includes persons aged 6-59 months; the quadrivalent vaccine had previously been approved for ages 5 years and up. A trivalent version of the Afluria influenza vaccine also now is indicated for people aged 6 months and up, according to an Oct. 4 communication from the FDA.
A total of 172 pediatric influenza-related deaths occurred in the United States during the 2017-2018 season, representing a new high in nonpandemic influenza seasons. About half of the pediatric influenza deaths occurred in otherwise healthy children, and about 22% of children who died were fully vaccinated, according to the Centers for Disease Control and Prevention, reporting U.S. data from 2010 to 2016.
“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” Seqirus’ vice president of medical affairs Gregg Sylvester, MD, said in a press release announcing the extended indication. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”
According to the CDC, the 2018-2019 influenza vaccine has been updated to provide a better match – and more protection against – viruses circulating in this influenza season. Specifically, says the CDC, the influenza B Victoria lineage and the influenza A(H3N2) components were updated.
In addition to providing protection against these two strains of influenza, trivalent vaccines for the 2018-2019 season are recommended to include protection against H1N1 influenza as well. Quadrivalent vaccines protect against a second influenza B lineage.
Most people will receive a quadrivalent vaccine this year, according to the CDC.
The expanded approval now includes persons aged 6-59 months; the quadrivalent vaccine had previously been approved for ages 5 years and up. A trivalent version of the Afluria influenza vaccine also now is indicated for people aged 6 months and up, according to an Oct. 4 communication from the FDA.
A total of 172 pediatric influenza-related deaths occurred in the United States during the 2017-2018 season, representing a new high in nonpandemic influenza seasons. About half of the pediatric influenza deaths occurred in otherwise healthy children, and about 22% of children who died were fully vaccinated, according to the Centers for Disease Control and Prevention, reporting U.S. data from 2010 to 2016.
“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” Seqirus’ vice president of medical affairs Gregg Sylvester, MD, said in a press release announcing the extended indication. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”
According to the CDC, the 2018-2019 influenza vaccine has been updated to provide a better match – and more protection against – viruses circulating in this influenza season. Specifically, says the CDC, the influenza B Victoria lineage and the influenza A(H3N2) components were updated.
In addition to providing protection against these two strains of influenza, trivalent vaccines for the 2018-2019 season are recommended to include protection against H1N1 influenza as well. Quadrivalent vaccines protect against a second influenza B lineage.
Most people will receive a quadrivalent vaccine this year, according to the CDC.
Ibrutinib plus obinutuzumab gets priority review in CLL/SLL
The Food and Drug Administration has granted priority review to an anti-CD20, chemotherapy-free combination – ibrutinib plus obinutuzumab – for the frontline treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
The agency will review the combination in previously untreated adults.
Ibrutinib (Imbruvica) is already approved as a single agent for adults with CLL/SLL for all lines of therapy and in combination with bendamustine and rituximab. Obinutuzumab (Gazyva) has been approved for patients with previously untreated CLL, in combination with chlorambucil.
The current application, which is sponsored by Janssen and Pharmacyclics, is based on results from the phase 3 iLLUMINATE trial. Preliminary results announced by Janssen and Pharmacyclics showed that ibrutinib plus obinutuzumab had statistically significant better progression-free survival, compared with chlorambucil plus obinutuzumab, as assessed by an independent review committee.
Complete results from the trial will be presented at an upcoming medical meeting, according to the sponsors.
The Food and Drug Administration has granted priority review to an anti-CD20, chemotherapy-free combination – ibrutinib plus obinutuzumab – for the frontline treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
The agency will review the combination in previously untreated adults.
Ibrutinib (Imbruvica) is already approved as a single agent for adults with CLL/SLL for all lines of therapy and in combination with bendamustine and rituximab. Obinutuzumab (Gazyva) has been approved for patients with previously untreated CLL, in combination with chlorambucil.
The current application, which is sponsored by Janssen and Pharmacyclics, is based on results from the phase 3 iLLUMINATE trial. Preliminary results announced by Janssen and Pharmacyclics showed that ibrutinib plus obinutuzumab had statistically significant better progression-free survival, compared with chlorambucil plus obinutuzumab, as assessed by an independent review committee.
Complete results from the trial will be presented at an upcoming medical meeting, according to the sponsors.
The Food and Drug Administration has granted priority review to an anti-CD20, chemotherapy-free combination – ibrutinib plus obinutuzumab – for the frontline treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
The agency will review the combination in previously untreated adults.
Ibrutinib (Imbruvica) is already approved as a single agent for adults with CLL/SLL for all lines of therapy and in combination with bendamustine and rituximab. Obinutuzumab (Gazyva) has been approved for patients with previously untreated CLL, in combination with chlorambucil.
The current application, which is sponsored by Janssen and Pharmacyclics, is based on results from the phase 3 iLLUMINATE trial. Preliminary results announced by Janssen and Pharmacyclics showed that ibrutinib plus obinutuzumab had statistically significant better progression-free survival, compared with chlorambucil plus obinutuzumab, as assessed by an independent review committee.
Complete results from the trial will be presented at an upcoming medical meeting, according to the sponsors.
Talazoparib approved for HER2-negative advanced breast cancer
The for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.
The FDA also approved BRACAnalysis CDx from Myriad Genetic Laboratories as the companion diagnostic to identify patients with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib, the agency announced.
Approval was based on improved progression-free survival in EMBRACA, a phase 3, open-label trial of 431 patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer. Patients in the trial were randomized 2:1 to receive either talazoparib (1 mg) or a physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients had received treatment with an anthracycline and/or a taxane previously.
Median progression-free survival was 8.6 months in the talazoparib arm, compared with 5.6 months in the chemotherapy arm (HR, 0.54; 95% CI, 0.41-0.71; P less than .0001).
Anemia was the most common hematologic adverse event, with grade 3 or greater occurring in 39.2% of patients on the PARP inhibitor, compared with 4.8% of patients treated with other agents, according to results of the trial presented at the 2017 San Antonio Breast Cancer Symposium.
Warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity are included in the drug’s prescribing information. The PARP inhibitor’s most common adverse reactions of any grade are fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite, the FDA said.
The recommended dose for talazoparib, marketed as Talzenna by Pfizer, is 1 mg taken as a single oral daily dose, with or without food.
The for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.
The FDA also approved BRACAnalysis CDx from Myriad Genetic Laboratories as the companion diagnostic to identify patients with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib, the agency announced.
Approval was based on improved progression-free survival in EMBRACA, a phase 3, open-label trial of 431 patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer. Patients in the trial were randomized 2:1 to receive either talazoparib (1 mg) or a physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients had received treatment with an anthracycline and/or a taxane previously.
Median progression-free survival was 8.6 months in the talazoparib arm, compared with 5.6 months in the chemotherapy arm (HR, 0.54; 95% CI, 0.41-0.71; P less than .0001).
Anemia was the most common hematologic adverse event, with grade 3 or greater occurring in 39.2% of patients on the PARP inhibitor, compared with 4.8% of patients treated with other agents, according to results of the trial presented at the 2017 San Antonio Breast Cancer Symposium.
Warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity are included in the drug’s prescribing information. The PARP inhibitor’s most common adverse reactions of any grade are fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite, the FDA said.
The recommended dose for talazoparib, marketed as Talzenna by Pfizer, is 1 mg taken as a single oral daily dose, with or without food.
The for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.
The FDA also approved BRACAnalysis CDx from Myriad Genetic Laboratories as the companion diagnostic to identify patients with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib, the agency announced.
Approval was based on improved progression-free survival in EMBRACA, a phase 3, open-label trial of 431 patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer. Patients in the trial were randomized 2:1 to receive either talazoparib (1 mg) or a physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients had received treatment with an anthracycline and/or a taxane previously.
Median progression-free survival was 8.6 months in the talazoparib arm, compared with 5.6 months in the chemotherapy arm (HR, 0.54; 95% CI, 0.41-0.71; P less than .0001).
Anemia was the most common hematologic adverse event, with grade 3 or greater occurring in 39.2% of patients on the PARP inhibitor, compared with 4.8% of patients treated with other agents, according to results of the trial presented at the 2017 San Antonio Breast Cancer Symposium.
Warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity are included in the drug’s prescribing information. The PARP inhibitor’s most common adverse reactions of any grade are fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite, the FDA said.
The recommended dose for talazoparib, marketed as Talzenna by Pfizer, is 1 mg taken as a single oral daily dose, with or without food.
FDA offers guidance on MRD assessment in blood cancer trials
The of patients with hematologic malignancies.
The FDA said it developed the document to assist drug sponsors who are planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application or to support FDA approval of products intended to treat hematologic malignancies.
“As a result of important workshops where we’ve heard from stakeholders and an analysis of marketing applications showing inconsistent quality of MRD data, the FDA identified a need to provide sponsors with guidance on the use of MRD as a biomarker in regulatory submissions,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The guidance explains how MRD might be used in clinical trials, highlights considerations for MRD assessment that are specific to certain hematologic malignancies, and lists requirements for regulatory submissions that utilize MRD.
MRD could potentially be used as a biomarker in clinical trials – specifically as a diagnostic, prognostic, predictive, efficacy-response, or monitoring biomarker, according to the draft guidance. Additionally, MRD could be used as a surrogate endpoint or “to select patients at high risk or to enrich the trial population.”
The draft guidance also provides specific considerations for MRD assessment in individual hematologic malignancies, including acute lymphoblastic leukemia, acute myeloid leukemia, acute promyelocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, and multiple myeloma.
The full document is available on the FDA website.
The of patients with hematologic malignancies.
The FDA said it developed the document to assist drug sponsors who are planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application or to support FDA approval of products intended to treat hematologic malignancies.
“As a result of important workshops where we’ve heard from stakeholders and an analysis of marketing applications showing inconsistent quality of MRD data, the FDA identified a need to provide sponsors with guidance on the use of MRD as a biomarker in regulatory submissions,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The guidance explains how MRD might be used in clinical trials, highlights considerations for MRD assessment that are specific to certain hematologic malignancies, and lists requirements for regulatory submissions that utilize MRD.
MRD could potentially be used as a biomarker in clinical trials – specifically as a diagnostic, prognostic, predictive, efficacy-response, or monitoring biomarker, according to the draft guidance. Additionally, MRD could be used as a surrogate endpoint or “to select patients at high risk or to enrich the trial population.”
The draft guidance also provides specific considerations for MRD assessment in individual hematologic malignancies, including acute lymphoblastic leukemia, acute myeloid leukemia, acute promyelocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, and multiple myeloma.
The full document is available on the FDA website.
The of patients with hematologic malignancies.
The FDA said it developed the document to assist drug sponsors who are planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application or to support FDA approval of products intended to treat hematologic malignancies.
“As a result of important workshops where we’ve heard from stakeholders and an analysis of marketing applications showing inconsistent quality of MRD data, the FDA identified a need to provide sponsors with guidance on the use of MRD as a biomarker in regulatory submissions,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The guidance explains how MRD might be used in clinical trials, highlights considerations for MRD assessment that are specific to certain hematologic malignancies, and lists requirements for regulatory submissions that utilize MRD.
MRD could potentially be used as a biomarker in clinical trials – specifically as a diagnostic, prognostic, predictive, efficacy-response, or monitoring biomarker, according to the draft guidance. Additionally, MRD could be used as a surrogate endpoint or “to select patients at high risk or to enrich the trial population.”
The draft guidance also provides specific considerations for MRD assessment in individual hematologic malignancies, including acute lymphoblastic leukemia, acute myeloid leukemia, acute promyelocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, and multiple myeloma.
The full document is available on the FDA website.
FDA approves DNA-based blood type test
The for use in transfusion.
It’s the second molecular test for blood compatibility but the first to report genotype in its results, according to an announcement from the agency.
The test is important because it evaluates patients – especially those who receive repeated blood transfusions for conditions such as sickle cell anemia – for non-ABO antigens, but it does so without using antisera, which is sometimes unavailable.
A study found comparable performance between the ID CORE XT, licensed serologic reagents, and DNA sequencing tests, according to the FDA.
The ID CORE XT test is marketed by Progenika Biopharma, a Grifols company.
More information can be found in the full FDA press announcement.
The for use in transfusion.
It’s the second molecular test for blood compatibility but the first to report genotype in its results, according to an announcement from the agency.
The test is important because it evaluates patients – especially those who receive repeated blood transfusions for conditions such as sickle cell anemia – for non-ABO antigens, but it does so without using antisera, which is sometimes unavailable.
A study found comparable performance between the ID CORE XT, licensed serologic reagents, and DNA sequencing tests, according to the FDA.
The ID CORE XT test is marketed by Progenika Biopharma, a Grifols company.
More information can be found in the full FDA press announcement.
The for use in transfusion.
It’s the second molecular test for blood compatibility but the first to report genotype in its results, according to an announcement from the agency.
The test is important because it evaluates patients – especially those who receive repeated blood transfusions for conditions such as sickle cell anemia – for non-ABO antigens, but it does so without using antisera, which is sometimes unavailable.
A study found comparable performance between the ID CORE XT, licensed serologic reagents, and DNA sequencing tests, according to the FDA.
The ID CORE XT test is marketed by Progenika Biopharma, a Grifols company.
More information can be found in the full FDA press announcement.
Rivaroxaban gains indication for prevention of major cardiovascular events in CAD/PAD
when taken with aspirin, Janssen Pharmaceuticals announced on October 11.
The Food and Drug Administration’s approval was based on a review of the 27,000-patient COMPASS trial, which showed last year that a low dosage of rivaroxaban (Xarelto) plus aspirin reduced the combined rate of cardiovascular disease events by 24% in patients with coronary artery disease and by 28% in participants with peripheral artery disease, compared with aspirin alone. (N Engl J Med. 2017 Oct 5;377[14]:1319-30)
The flip side to the reduction in COMPASS’s combined primary endpoint was a 51% increase in major bleeding. However, that bump did not translate to increases in fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.
COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) studied two dosages of rivaroxaban, 2.5 mg and 5 mg twice daily, and it was the lower dosage that did the trick. Until this approval, that formulation wasn’t available; Janssen announced the coming of the 2.5-mg pill in its release.
The new prescribing information states specifically that Xarelto 2.5 mg is indicated, in combination with aspirin, to reduce the risk of major cardiovascular events, cardiovascular death, MI, and stroke in patients with chronic coronary artery disease or peripheral artery disease.
This is the sixth indication for rivaroxaban, a factor Xa inhibitor that was first approved in 2011. It is also the first indication for cardiovascular prevention for any factor Xa inhibitor. Others on the U.S. market are apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa).
COMPASS was presented at the 2017 annual congress of the European Society of Cardiology. At that time, Eugene Braunwald, MD, of Harvard Medical School and Brigham and Women’s Hospital in Boston, commented that the trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease.” He added that the results are “an important step for thrombocardiology.”
when taken with aspirin, Janssen Pharmaceuticals announced on October 11.
The Food and Drug Administration’s approval was based on a review of the 27,000-patient COMPASS trial, which showed last year that a low dosage of rivaroxaban (Xarelto) plus aspirin reduced the combined rate of cardiovascular disease events by 24% in patients with coronary artery disease and by 28% in participants with peripheral artery disease, compared with aspirin alone. (N Engl J Med. 2017 Oct 5;377[14]:1319-30)
The flip side to the reduction in COMPASS’s combined primary endpoint was a 51% increase in major bleeding. However, that bump did not translate to increases in fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.
COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) studied two dosages of rivaroxaban, 2.5 mg and 5 mg twice daily, and it was the lower dosage that did the trick. Until this approval, that formulation wasn’t available; Janssen announced the coming of the 2.5-mg pill in its release.
The new prescribing information states specifically that Xarelto 2.5 mg is indicated, in combination with aspirin, to reduce the risk of major cardiovascular events, cardiovascular death, MI, and stroke in patients with chronic coronary artery disease or peripheral artery disease.
This is the sixth indication for rivaroxaban, a factor Xa inhibitor that was first approved in 2011. It is also the first indication for cardiovascular prevention for any factor Xa inhibitor. Others on the U.S. market are apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa).
COMPASS was presented at the 2017 annual congress of the European Society of Cardiology. At that time, Eugene Braunwald, MD, of Harvard Medical School and Brigham and Women’s Hospital in Boston, commented that the trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease.” He added that the results are “an important step for thrombocardiology.”
when taken with aspirin, Janssen Pharmaceuticals announced on October 11.
The Food and Drug Administration’s approval was based on a review of the 27,000-patient COMPASS trial, which showed last year that a low dosage of rivaroxaban (Xarelto) plus aspirin reduced the combined rate of cardiovascular disease events by 24% in patients with coronary artery disease and by 28% in participants with peripheral artery disease, compared with aspirin alone. (N Engl J Med. 2017 Oct 5;377[14]:1319-30)
The flip side to the reduction in COMPASS’s combined primary endpoint was a 51% increase in major bleeding. However, that bump did not translate to increases in fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.
COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) studied two dosages of rivaroxaban, 2.5 mg and 5 mg twice daily, and it was the lower dosage that did the trick. Until this approval, that formulation wasn’t available; Janssen announced the coming of the 2.5-mg pill in its release.
The new prescribing information states specifically that Xarelto 2.5 mg is indicated, in combination with aspirin, to reduce the risk of major cardiovascular events, cardiovascular death, MI, and stroke in patients with chronic coronary artery disease or peripheral artery disease.
This is the sixth indication for rivaroxaban, a factor Xa inhibitor that was first approved in 2011. It is also the first indication for cardiovascular prevention for any factor Xa inhibitor. Others on the U.S. market are apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa).
COMPASS was presented at the 2017 annual congress of the European Society of Cardiology. At that time, Eugene Braunwald, MD, of Harvard Medical School and Brigham and Women’s Hospital in Boston, commented that the trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease.” He added that the results are “an important step for thrombocardiology.”