User login
New U.S. cancer cases may exceed 2.3 million by 2035
The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report, detailing recent advances in the fight against cancer and calling on elected officials to address the challenges that remain.
The AACR Cancer Progress Report 2018 lists the 22 new approvals for cancer treatments that have occurred during the last 12 months, including 12 therapies approved to treat hematologic malignancies.
However, the report also notes that cancer continues to pose immense public health challenges in the United States.
The estimated number of new cancer cases for 2018 is 1,735,350, and the estimated number of cancer deaths is 609,640.
The number of new cancer cases is predicted to increase to 2,387,304 in 2035. This is due, in large part, to the rising number of people age 65 and older, according to the report.
With this in mind, the AACR is calling on elected officials to:
Maintain “robust, sustained, and predictable growth” of the National Institutes of Health (NIH) budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.
Make sure the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives—including the National Cancer Moonshot—“is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”
Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion—a $308 million increase above its FY 2018 level—to secure support for regulatory science and speed the development of medical products that are safe and effective.
Provide the Centers for Disease Control and Prevention’s Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”
The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report, detailing recent advances in the fight against cancer and calling on elected officials to address the challenges that remain.
The AACR Cancer Progress Report 2018 lists the 22 new approvals for cancer treatments that have occurred during the last 12 months, including 12 therapies approved to treat hematologic malignancies.
However, the report also notes that cancer continues to pose immense public health challenges in the United States.
The estimated number of new cancer cases for 2018 is 1,735,350, and the estimated number of cancer deaths is 609,640.
The number of new cancer cases is predicted to increase to 2,387,304 in 2035. This is due, in large part, to the rising number of people age 65 and older, according to the report.
With this in mind, the AACR is calling on elected officials to:
Maintain “robust, sustained, and predictable growth” of the National Institutes of Health (NIH) budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.
Make sure the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives—including the National Cancer Moonshot—“is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”
Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion—a $308 million increase above its FY 2018 level—to secure support for regulatory science and speed the development of medical products that are safe and effective.
Provide the Centers for Disease Control and Prevention’s Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”
The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report, detailing recent advances in the fight against cancer and calling on elected officials to address the challenges that remain.
The AACR Cancer Progress Report 2018 lists the 22 new approvals for cancer treatments that have occurred during the last 12 months, including 12 therapies approved to treat hematologic malignancies.
However, the report also notes that cancer continues to pose immense public health challenges in the United States.
The estimated number of new cancer cases for 2018 is 1,735,350, and the estimated number of cancer deaths is 609,640.
The number of new cancer cases is predicted to increase to 2,387,304 in 2035. This is due, in large part, to the rising number of people age 65 and older, according to the report.
With this in mind, the AACR is calling on elected officials to:
Maintain “robust, sustained, and predictable growth” of the National Institutes of Health (NIH) budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.
Make sure the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives—including the National Cancer Moonshot—“is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”
Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion—a $308 million increase above its FY 2018 level—to secure support for regulatory science and speed the development of medical products that are safe and effective.
Provide the Centers for Disease Control and Prevention’s Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”
AACR: New cancer cases predicted to rise above 2.3 million by 2035
during the last 12 months.
Among the advances outlined in the AACR Cancer Progress Report 2018 are “revolutionary new immunotherapeutics called CAR T–cell therapies, exciting new targeted radiotherapeutics, and numerous new targeted therapeutics that are expanding the scope of precision medicine,” the AACR said in a written statement.
Despite this progress, however, cancer continues to pose immense public health challenges.
The number of new cancer cases in the United States is predicted to increase from more than 1.7 million in 2018 to almost 2.4 million in 2035, due in large part to the rising number of people age 65 and older, according to the report.
AACR calls on elected officials to:
- Maintain “robust, sustained, and predictable growth” of the National Institutes of Health budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.
- Make sure that the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives – including the National Cancer Moonshot – “is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”
- Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion – a $308 million increase above its FY 2018 level – to secure support for regulatory science and speed the development of medical products, ones that are safe and effective. Particularly, in FY 2019, the AACR backs a funding level of $20 million for the FDA Oncology Center of Excellence.
- Provide the Centers for Disease Control and Prevention Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”
Read the full report and watch video stories from patients here.
during the last 12 months.
Among the advances outlined in the AACR Cancer Progress Report 2018 are “revolutionary new immunotherapeutics called CAR T–cell therapies, exciting new targeted radiotherapeutics, and numerous new targeted therapeutics that are expanding the scope of precision medicine,” the AACR said in a written statement.
Despite this progress, however, cancer continues to pose immense public health challenges.
The number of new cancer cases in the United States is predicted to increase from more than 1.7 million in 2018 to almost 2.4 million in 2035, due in large part to the rising number of people age 65 and older, according to the report.
AACR calls on elected officials to:
- Maintain “robust, sustained, and predictable growth” of the National Institutes of Health budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.
- Make sure that the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives – including the National Cancer Moonshot – “is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”
- Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion – a $308 million increase above its FY 2018 level – to secure support for regulatory science and speed the development of medical products, ones that are safe and effective. Particularly, in FY 2019, the AACR backs a funding level of $20 million for the FDA Oncology Center of Excellence.
- Provide the Centers for Disease Control and Prevention Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”
Read the full report and watch video stories from patients here.
during the last 12 months.
Among the advances outlined in the AACR Cancer Progress Report 2018 are “revolutionary new immunotherapeutics called CAR T–cell therapies, exciting new targeted radiotherapeutics, and numerous new targeted therapeutics that are expanding the scope of precision medicine,” the AACR said in a written statement.
Despite this progress, however, cancer continues to pose immense public health challenges.
The number of new cancer cases in the United States is predicted to increase from more than 1.7 million in 2018 to almost 2.4 million in 2035, due in large part to the rising number of people age 65 and older, according to the report.
AACR calls on elected officials to:
- Maintain “robust, sustained, and predictable growth” of the National Institutes of Health budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.
- Make sure that the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives – including the National Cancer Moonshot – “is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”
- Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion – a $308 million increase above its FY 2018 level – to secure support for regulatory science and speed the development of medical products, ones that are safe and effective. Particularly, in FY 2019, the AACR backs a funding level of $20 million for the FDA Oncology Center of Excellence.
- Provide the Centers for Disease Control and Prevention Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”
Read the full report and watch video stories from patients here.
FDA grants full approval to pembrolizumab for advanced NSCLC
(NSCLC), with no EGFR or ALK genomic tumor aberrations.
The checkpoint inhibitor was previously approved for patients with metastatic nonsquamous NSCLC in 2017, under the accelerated approval process, based on phase 2 results. Approval is now converted to a full approval, based on the results of the phase 3 Keynote-189 trial.
Patients in Keynote-189 who received pembrolizumab in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (hazard ratio, 0.49 [95% confidence interval, 0.38-0.64]; P less than .00001), according to the company press statement.
There was also a significant improvement in progression-free survival (PFS) with the pembrolizumab plus chemotherapy combination, compared with chemotherapy alone (HR, 0.52 [95% CI, 0.43-0.64]; P less than .00001).
Patients with metastatic NSCLC, regardless of PD-L1 tumor expression status and with no EGFR or ALK genomic tumor aberrations were randomized to receive pembrolizumab 200 mg, cisplatin or carboplatin, and pemetrexed intravenously every 3 weeks for four cycles followed by pembrolizumab 200 mg for up to 24 months and pemetrexed every 3 weeks (n = 410); or cisplatin or carboplatin and pemetrexed intravenously every 3 weeks for four cycles followed by pemetrexed every 3 weeks (n = 206). Treatment continued until progression of disease or unacceptable toxicity.
The most common adverse reactions with pembrolizumab, resulting in discontinuation, were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions or laboratory abnormalities resulting in interruption of treatment were neutropenia (13%), asthenia/fatigue (7%), anemia (7%), and thrombocytopenia (5%).
(NSCLC), with no EGFR or ALK genomic tumor aberrations.
The checkpoint inhibitor was previously approved for patients with metastatic nonsquamous NSCLC in 2017, under the accelerated approval process, based on phase 2 results. Approval is now converted to a full approval, based on the results of the phase 3 Keynote-189 trial.
Patients in Keynote-189 who received pembrolizumab in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (hazard ratio, 0.49 [95% confidence interval, 0.38-0.64]; P less than .00001), according to the company press statement.
There was also a significant improvement in progression-free survival (PFS) with the pembrolizumab plus chemotherapy combination, compared with chemotherapy alone (HR, 0.52 [95% CI, 0.43-0.64]; P less than .00001).
Patients with metastatic NSCLC, regardless of PD-L1 tumor expression status and with no EGFR or ALK genomic tumor aberrations were randomized to receive pembrolizumab 200 mg, cisplatin or carboplatin, and pemetrexed intravenously every 3 weeks for four cycles followed by pembrolizumab 200 mg for up to 24 months and pemetrexed every 3 weeks (n = 410); or cisplatin or carboplatin and pemetrexed intravenously every 3 weeks for four cycles followed by pemetrexed every 3 weeks (n = 206). Treatment continued until progression of disease or unacceptable toxicity.
The most common adverse reactions with pembrolizumab, resulting in discontinuation, were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions or laboratory abnormalities resulting in interruption of treatment were neutropenia (13%), asthenia/fatigue (7%), anemia (7%), and thrombocytopenia (5%).
(NSCLC), with no EGFR or ALK genomic tumor aberrations.
The checkpoint inhibitor was previously approved for patients with metastatic nonsquamous NSCLC in 2017, under the accelerated approval process, based on phase 2 results. Approval is now converted to a full approval, based on the results of the phase 3 Keynote-189 trial.
Patients in Keynote-189 who received pembrolizumab in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (hazard ratio, 0.49 [95% confidence interval, 0.38-0.64]; P less than .00001), according to the company press statement.
There was also a significant improvement in progression-free survival (PFS) with the pembrolizumab plus chemotherapy combination, compared with chemotherapy alone (HR, 0.52 [95% CI, 0.43-0.64]; P less than .00001).
Patients with metastatic NSCLC, regardless of PD-L1 tumor expression status and with no EGFR or ALK genomic tumor aberrations were randomized to receive pembrolizumab 200 mg, cisplatin or carboplatin, and pemetrexed intravenously every 3 weeks for four cycles followed by pembrolizumab 200 mg for up to 24 months and pemetrexed every 3 weeks (n = 410); or cisplatin or carboplatin and pemetrexed intravenously every 3 weeks for four cycles followed by pemetrexed every 3 weeks (n = 206). Treatment continued until progression of disease or unacceptable toxicity.
The most common adverse reactions with pembrolizumab, resulting in discontinuation, were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions or laboratory abnormalities resulting in interruption of treatment were neutropenia (13%), asthenia/fatigue (7%), anemia (7%), and thrombocytopenia (5%).
FDA grants accelerated approval for Opdivo in metastatic SCLC
The Food and Drug Administration has granted accelerated approval to nivolumab (Opdivo) for treating patients with metastatic small-cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Approval was based on an overall response rate and duration of response in the monotherapy arm of the multicohort phase 1/2 CheckMate 032 trial. Of 109 patients with SCLC and progression after at least one previous platinum-containing regimen, 12% responded to monotherapy treatment with nivolumab regardless of PD-L1 status, 12 patients had a partial response, and one patient had a complete response.
Among responders, the median duration of response was 17.9 months. Results of the trial were presented at the ASCO annual meeting and published online in The Lancet Oncology in 2016.
Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration.
The approved dose is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity, the company said in a press statement announcing the approval.
The checkpoint inhibitor was approved for treating patients with metastatic non–small-cell lung cancer with progression on or after platinum-based chemotherapy in 2015.
The Food and Drug Administration has granted accelerated approval to nivolumab (Opdivo) for treating patients with metastatic small-cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Approval was based on an overall response rate and duration of response in the monotherapy arm of the multicohort phase 1/2 CheckMate 032 trial. Of 109 patients with SCLC and progression after at least one previous platinum-containing regimen, 12% responded to monotherapy treatment with nivolumab regardless of PD-L1 status, 12 patients had a partial response, and one patient had a complete response.
Among responders, the median duration of response was 17.9 months. Results of the trial were presented at the ASCO annual meeting and published online in The Lancet Oncology in 2016.
Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration.
The approved dose is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity, the company said in a press statement announcing the approval.
The checkpoint inhibitor was approved for treating patients with metastatic non–small-cell lung cancer with progression on or after platinum-based chemotherapy in 2015.
The Food and Drug Administration has granted accelerated approval to nivolumab (Opdivo) for treating patients with metastatic small-cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Approval was based on an overall response rate and duration of response in the monotherapy arm of the multicohort phase 1/2 CheckMate 032 trial. Of 109 patients with SCLC and progression after at least one previous platinum-containing regimen, 12% responded to monotherapy treatment with nivolumab regardless of PD-L1 status, 12 patients had a partial response, and one patient had a complete response.
Among responders, the median duration of response was 17.9 months. Results of the trial were presented at the ASCO annual meeting and published online in The Lancet Oncology in 2016.
Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration.
The approved dose is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity, the company said in a press statement announcing the approval.
The checkpoint inhibitor was approved for treating patients with metastatic non–small-cell lung cancer with progression on or after platinum-based chemotherapy in 2015.
FDA requires companion diagnostics for checkpoint inhibitors in urothelial cancer
Two separate FDA-approved companion diagnostic tests are now required to determine PD-L1 levels in tumor tissue for those who are cisplatin-ineligible.
Pembrolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy and whose tumors have a Combined Positive Score (CPS) for PD-L1 expression of greater than or equal to 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay for determining PD-L1 expression, through staining in tumor and immune cells, before prescribing pembrolizumab.
Atezolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy, and whose tumors show PD-L1 expression through stained tumor-infiltrating immune cells covering greater than or equal to 5% of the tumor area, or patients who are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression. The FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to determine PD L1 expression in immune cells before prescribing atezolizumab.
PI is updated for both drugs to require use of an FDA-approved test for selection of patients being treated in the first-line setting who are cisplatin-ineligible, but second-line indications in urothelial carcinoma for both drugs remain unchanged, according to an FDA statement.
Two separate FDA-approved companion diagnostic tests are now required to determine PD-L1 levels in tumor tissue for those who are cisplatin-ineligible.
Pembrolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy and whose tumors have a Combined Positive Score (CPS) for PD-L1 expression of greater than or equal to 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay for determining PD-L1 expression, through staining in tumor and immune cells, before prescribing pembrolizumab.
Atezolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy, and whose tumors show PD-L1 expression through stained tumor-infiltrating immune cells covering greater than or equal to 5% of the tumor area, or patients who are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression. The FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to determine PD L1 expression in immune cells before prescribing atezolizumab.
PI is updated for both drugs to require use of an FDA-approved test for selection of patients being treated in the first-line setting who are cisplatin-ineligible, but second-line indications in urothelial carcinoma for both drugs remain unchanged, according to an FDA statement.
Two separate FDA-approved companion diagnostic tests are now required to determine PD-L1 levels in tumor tissue for those who are cisplatin-ineligible.
Pembrolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy and whose tumors have a Combined Positive Score (CPS) for PD-L1 expression of greater than or equal to 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay for determining PD-L1 expression, through staining in tumor and immune cells, before prescribing pembrolizumab.
Atezolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy, and whose tumors show PD-L1 expression through stained tumor-infiltrating immune cells covering greater than or equal to 5% of the tumor area, or patients who are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression. The FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to determine PD L1 expression in immune cells before prescribing atezolizumab.
PI is updated for both drugs to require use of an FDA-approved test for selection of patients being treated in the first-line setting who are cisplatin-ineligible, but second-line indications in urothelial carcinoma for both drugs remain unchanged, according to an FDA statement.
FDA approves lenvatinib for HCC
Approval was based on a noninferiority trial of 954 patients with previously untreated, metastatic or unresectable HCC, comparing treatment with lenvatinib to sorafenib, according to an FDA statement.
Lenvatinib was found noninferior but not statistically superior to sorafenib for overall survival (hazard ratio, 0.92; 95% confidence interval, 0.79-1.06). Median overall survival was 13.6 months for patients in the lenvatinib arm, compared with 12.3 months for patients in the sorafenib arm.
The most common adverse reactions with lenvatinib were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.
The recommended lenvatinib dosages are 12 mg orally once daily in patients weighing 60 kg or greater actual body weight or 8 mg orally once daily in patients weighing less than 60 kg actual body weight, the FDA said.
Lenvatinib is marketed as Lenvima by Eisai.
Approval was based on a noninferiority trial of 954 patients with previously untreated, metastatic or unresectable HCC, comparing treatment with lenvatinib to sorafenib, according to an FDA statement.
Lenvatinib was found noninferior but not statistically superior to sorafenib for overall survival (hazard ratio, 0.92; 95% confidence interval, 0.79-1.06). Median overall survival was 13.6 months for patients in the lenvatinib arm, compared with 12.3 months for patients in the sorafenib arm.
The most common adverse reactions with lenvatinib were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.
The recommended lenvatinib dosages are 12 mg orally once daily in patients weighing 60 kg or greater actual body weight or 8 mg orally once daily in patients weighing less than 60 kg actual body weight, the FDA said.
Lenvatinib is marketed as Lenvima by Eisai.
Approval was based on a noninferiority trial of 954 patients with previously untreated, metastatic or unresectable HCC, comparing treatment with lenvatinib to sorafenib, according to an FDA statement.
Lenvatinib was found noninferior but not statistically superior to sorafenib for overall survival (hazard ratio, 0.92; 95% confidence interval, 0.79-1.06). Median overall survival was 13.6 months for patients in the lenvatinib arm, compared with 12.3 months for patients in the sorafenib arm.
The most common adverse reactions with lenvatinib were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.
The recommended lenvatinib dosages are 12 mg orally once daily in patients weighing 60 kg or greater actual body weight or 8 mg orally once daily in patients weighing less than 60 kg actual body weight, the FDA said.
Lenvatinib is marketed as Lenvima by Eisai.
Phase 1 CAR T trial for NHL launches in Cleveland
University Hospitals Seidman Cancer Center in Cleveland has launched a phase 1 clinical trial to study the safety of CAR T therapy for non-Hodgkin lymphoma.
The trial will enroll 12-15 adult patients with non-Hodgkin lymphoma who have not responded to standard therapies, according to a statement from University Hospitals Seidman Cancer Center.
The principal investigator for the trial will be Paolo Caimi, MD, of UH Seidman and Case Western Reserve University.
UH Seidman, affiliated with Case Western Reserve University, is one of a handful of centers that has the ability to manufacture the CAR T cells from the patient’s own genetically modified T cells on site in the shared Case Western Reserve University National Center for Regenerative Medicine and the UH Seidman Cellular Therapy Laboratory, saving time for patients.
“Having the ability to make cells on-site means there will be a shorter turnaround time in having the cells available for the patient, compared to shipping them off-site,” said Dr. Caimi in the press statement.
University Hospitals Seidman Cancer Center in Cleveland has launched a phase 1 clinical trial to study the safety of CAR T therapy for non-Hodgkin lymphoma.
The trial will enroll 12-15 adult patients with non-Hodgkin lymphoma who have not responded to standard therapies, according to a statement from University Hospitals Seidman Cancer Center.
The principal investigator for the trial will be Paolo Caimi, MD, of UH Seidman and Case Western Reserve University.
UH Seidman, affiliated with Case Western Reserve University, is one of a handful of centers that has the ability to manufacture the CAR T cells from the patient’s own genetically modified T cells on site in the shared Case Western Reserve University National Center for Regenerative Medicine and the UH Seidman Cellular Therapy Laboratory, saving time for patients.
“Having the ability to make cells on-site means there will be a shorter turnaround time in having the cells available for the patient, compared to shipping them off-site,” said Dr. Caimi in the press statement.
University Hospitals Seidman Cancer Center in Cleveland has launched a phase 1 clinical trial to study the safety of CAR T therapy for non-Hodgkin lymphoma.
The trial will enroll 12-15 adult patients with non-Hodgkin lymphoma who have not responded to standard therapies, according to a statement from University Hospitals Seidman Cancer Center.
The principal investigator for the trial will be Paolo Caimi, MD, of UH Seidman and Case Western Reserve University.
UH Seidman, affiliated with Case Western Reserve University, is one of a handful of centers that has the ability to manufacture the CAR T cells from the patient’s own genetically modified T cells on site in the shared Case Western Reserve University National Center for Regenerative Medicine and the UH Seidman Cellular Therapy Laboratory, saving time for patients.
“Having the ability to make cells on-site means there will be a shorter turnaround time in having the cells available for the patient, compared to shipping them off-site,” said Dr. Caimi in the press statement.
Key clinical point: A phase 1 trial of CAR T therapy is enrolling adult patients with NHL who have not responded to standard therapies.
Major finding: The trial site has the ability to manufacture the cells on site, saving patients time.
Study details: A phase 1 trial to evaluate safety.
Disclosures: The study will be funded by University Hospitals Seidman Cancer Center.
ASCO calls for expanding clinical trial eligibility
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
Key clinical point: ASCO and Friends of Cancer have submitted draft recommendations to the FDA for expanding cancer clinical trial participation.
Major finding: The organizations recommend addressing minimum age requirements, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
Data source: Draft guidance produced by ASCO and Friends of Cancer Research and submitted to the FDA.
Disclosures: Individual members of the working groups were not listed and conflicts of interest were not disclosed.
Source: Friends of Cancer and ASCO letter to the FDA.
FDA expands indication for ribociclib for advanced breast cancer
The Food and Drug Administration has approved ribociclib (Kisqali) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
Ribociclib was first approved in March 2017 for use with an AI to treat HR-positive, HER2-negative advanced breast cancer in postmenopausal women.
Approval for ribociclib in combination with an AI for pre/perimenopausal women was based on progression-free survival (PFS) in MONALEESA-7, a trial of premenopausal women with HR-positive, HER2-negative, advanced breast cancer. The women received either ribociclib and an AI, or placebo and an AI, and all also received ovarian suppression with goserelin (Zoladex). Of 495 women who received nonsteroidal AIs, median PFS was 27.5 months for women also receiving ribociclib, versus 13.8 months for women who received placebo plus the AI.
Approval for ribociclib in combination with fulvestrant in treating advanced or metastatic breast cancer was based on PFS results from MONALEESA-3, which enrolled 726 women with HR-positive, HER2-negative, advanced breast cancer who received no or up to one line of prior endocrine therapy. Median PFS was 20.5 months for women randomized to receive ribociclib and fulvestrant, compared with 12.8 months for women randomized to receive placebo plus fulvestrant.
The common side effects of ribociclib are infections, neutropenia, leukopenia, headache, cough, nausea, fatigue, diarrhea, vomiting, constipation, hair loss, and rash. Warnings include the risk of QT prolongation, serious liver problems, low white blood cell counts, and fetal harm, the FDA said.
This is the first FDA approval as part of two new pilot programs announced earlier this year: Real-Time Oncology Review allows for the FDA to review much of the data earlier, before the information is formally submitted to the FDA, and the Assessment Aid is a structured template that offers a more streamlined approach.
“With today’s approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor’s analysis of the top-line data to tease out the most relevant information,” FDA Commissioner Scott Gottlieb, MD, said in the press statement. “This enabled our approval less than 1 month after the June 28 submission date and several months ahead of the goal date.”
The two pilot programs are currently being used for supplemental applications for already approved cancer drugs and could later be expanded to original drugs and biologics, the FDA said.
Ribociclib is marketed as Kisqali by Novartis Pharmaceuticals Corporation.
The Food and Drug Administration has approved ribociclib (Kisqali) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
Ribociclib was first approved in March 2017 for use with an AI to treat HR-positive, HER2-negative advanced breast cancer in postmenopausal women.
Approval for ribociclib in combination with an AI for pre/perimenopausal women was based on progression-free survival (PFS) in MONALEESA-7, a trial of premenopausal women with HR-positive, HER2-negative, advanced breast cancer. The women received either ribociclib and an AI, or placebo and an AI, and all also received ovarian suppression with goserelin (Zoladex). Of 495 women who received nonsteroidal AIs, median PFS was 27.5 months for women also receiving ribociclib, versus 13.8 months for women who received placebo plus the AI.
Approval for ribociclib in combination with fulvestrant in treating advanced or metastatic breast cancer was based on PFS results from MONALEESA-3, which enrolled 726 women with HR-positive, HER2-negative, advanced breast cancer who received no or up to one line of prior endocrine therapy. Median PFS was 20.5 months for women randomized to receive ribociclib and fulvestrant, compared with 12.8 months for women randomized to receive placebo plus fulvestrant.
The common side effects of ribociclib are infections, neutropenia, leukopenia, headache, cough, nausea, fatigue, diarrhea, vomiting, constipation, hair loss, and rash. Warnings include the risk of QT prolongation, serious liver problems, low white blood cell counts, and fetal harm, the FDA said.
This is the first FDA approval as part of two new pilot programs announced earlier this year: Real-Time Oncology Review allows for the FDA to review much of the data earlier, before the information is formally submitted to the FDA, and the Assessment Aid is a structured template that offers a more streamlined approach.
“With today’s approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor’s analysis of the top-line data to tease out the most relevant information,” FDA Commissioner Scott Gottlieb, MD, said in the press statement. “This enabled our approval less than 1 month after the June 28 submission date and several months ahead of the goal date.”
The two pilot programs are currently being used for supplemental applications for already approved cancer drugs and could later be expanded to original drugs and biologics, the FDA said.
Ribociclib is marketed as Kisqali by Novartis Pharmaceuticals Corporation.
The Food and Drug Administration has approved ribociclib (Kisqali) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
Ribociclib was first approved in March 2017 for use with an AI to treat HR-positive, HER2-negative advanced breast cancer in postmenopausal women.
Approval for ribociclib in combination with an AI for pre/perimenopausal women was based on progression-free survival (PFS) in MONALEESA-7, a trial of premenopausal women with HR-positive, HER2-negative, advanced breast cancer. The women received either ribociclib and an AI, or placebo and an AI, and all also received ovarian suppression with goserelin (Zoladex). Of 495 women who received nonsteroidal AIs, median PFS was 27.5 months for women also receiving ribociclib, versus 13.8 months for women who received placebo plus the AI.
Approval for ribociclib in combination with fulvestrant in treating advanced or metastatic breast cancer was based on PFS results from MONALEESA-3, which enrolled 726 women with HR-positive, HER2-negative, advanced breast cancer who received no or up to one line of prior endocrine therapy. Median PFS was 20.5 months for women randomized to receive ribociclib and fulvestrant, compared with 12.8 months for women randomized to receive placebo plus fulvestrant.
The common side effects of ribociclib are infections, neutropenia, leukopenia, headache, cough, nausea, fatigue, diarrhea, vomiting, constipation, hair loss, and rash. Warnings include the risk of QT prolongation, serious liver problems, low white blood cell counts, and fetal harm, the FDA said.
This is the first FDA approval as part of two new pilot programs announced earlier this year: Real-Time Oncology Review allows for the FDA to review much of the data earlier, before the information is formally submitted to the FDA, and the Assessment Aid is a structured template that offers a more streamlined approach.
“With today’s approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor’s analysis of the top-line data to tease out the most relevant information,” FDA Commissioner Scott Gottlieb, MD, said in the press statement. “This enabled our approval less than 1 month after the June 28 submission date and several months ahead of the goal date.”
The two pilot programs are currently being used for supplemental applications for already approved cancer drugs and could later be expanded to original drugs and biologics, the FDA said.
Ribociclib is marketed as Kisqali by Novartis Pharmaceuticals Corporation.
FDA approves first biosimilar to pegfilgrastim
to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
The approval is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim, the FDA said in a statement.
The FDA warns that “patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb.”
This approval is part of the FDA’s efforts to “help promote competition that can reduce drug costs and promote access,” FDA commissioner Scott Gottlieb, MD, said in the statement. “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”
Pegfilgrastim-jmdb will be marketed as Fulphila by Mylan GmbH.
to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
The approval is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim, the FDA said in a statement.
The FDA warns that “patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb.”
This approval is part of the FDA’s efforts to “help promote competition that can reduce drug costs and promote access,” FDA commissioner Scott Gottlieb, MD, said in the statement. “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”
Pegfilgrastim-jmdb will be marketed as Fulphila by Mylan GmbH.
to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
The approval is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim, the FDA said in a statement.
The FDA warns that “patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb.”
This approval is part of the FDA’s efforts to “help promote competition that can reduce drug costs and promote access,” FDA commissioner Scott Gottlieb, MD, said in the statement. “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”
Pegfilgrastim-jmdb will be marketed as Fulphila by Mylan GmbH.