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FDA Approvals in FL and RCC, Breakthrough Designation in Myeloma, and More

Gina Columbus
Published Online: Wednesday, Dec 06, 2017



Today-

FDA approvals in follicular lymphoma and renal cell carcinoma, a breakthrough therapy designation in multiple myeloma, promising combination results in a lung cancer trial, and a European approval in pediatric chronic myeloid leukemia.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with advanced follicular lymphoma. The indication is for patients with stage II bulky, III, or IV disease.

The approval is based on data from the international phase III GALLIUM study, in which combining obinutuzumab with chemotherapy in the first-line setting reduced the risk of disease progression or death by 28% versus rituximab plus chemotherapy in patients with follicular lymphoma.

Additional findings showed that, at a median follow-up of 41.1 months, the hazard ratio for progression-free survival by investigator assessment was 0.68. Per independent review, the HR for PFS was 0.72. The median PFS has not been reached yet in either treatment arm.

The overall response rate was 91% in the obinutuzumab arm and 88% in the control arm. Complete remission rates were 28% and 27%, respectively.

*****************************************

In renal cell carcinoma, the FDA has approved sunitinib for use as an adjuvant therapy in patients who have received nephrectomy and are high risk for recurrence.

The agency approved sunitinib for this indication despite a 6 to 6 split vote on the potential approval from its Oncologic Drugs Advisory Committee in September.

The approval is based on results from the phase III S-TRAC trial, in which adjuvant sunitinib prolonged disease-free survival by 1.2 years compared with placebo following nephrectomy for patients with high-risk clear cell RCC.

After a median follow-up of 5.4 years, the median DFS was 6.8 years in the sunitinib arm versus 5.6 years with placebo. In higher risk patients, the median DFS was 6.2 versus 4.0 years for sunitinib and placebo, respectively.

Grade 3/4 adverse events were experienced by 63.4% of patients in the sunitinib group compared with 21.7% in the placebo arm.

After 3 years, 64.9% of those in the sunitinib group were alive and remained disease-free compared with 59.5% in the placebo arm. At 5 years, the DFS rate was 59.3% with sunitinib versus 51.3% for placebo. Median overall survival findings were not yet mature at the time of the analysis; however, the hazard ratio between the two arms for survival was 1.01.

*****************************************

The FDA has granted bb2121 a breakthrough therapy designation for previously treated patients with relapsed/refractory multiple myeloma.

In a press release, the companies developing bb2121, Celgene Corporation and bluebird bio, reported that the investigational agent had also been awarded PRIority MEdicines eligibility by the European Medicines Agency. bb2121 is an anti–B-cell maturation antigen chimeric antigen receptor T-cell therapy.

The regulatory decisions were based on preliminary clinical data from the ongoing phase I CRB-401 study. The companies did not release any updated data, but noted that updating findings would be presented at the 2017 ASH Annual Meeting.

Early results presented in June 2017 showed that 75% of patients receiving the treatment demonstrated a very good partial response or better and 27% had a complete response.

The overall response across all dose levels was 89%. The median time to first response was 31 days, and the median time to best response was 50.5 days. The duration of response was 134 days and longer.

******************************

In non–small cell lung cancer, the addition of atezolizumab to bevacizumab, carboplatin, and paclitaxel was found to delay progression or death versus bevacizumab and chemotherapy alone for patients with advanced nonsquamous disease.

The topline findings were from the randomized phase III IMpower150 trial. Data from the interim analysis of the trial are being presented in December at the ESMO Immuno Oncology Congress, according to Roche, the manufacturer of both agents.

The co-primary endpoints for the IMpower150 study were progression-free survival and overall survival. Although exact numbers have not yet been released, Roche called the reduction in progression or death with the addition of atezolizumab clinically meaningful, adding that, at the interim analysis, data for overall survival were not yet mature but are encouraging.

Additionally, the company has initiated discussions with the FDA and EMA regarding regulatory approval.

**************************************

The European Commission has approved nilotinib for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, both in the frontline setting and for those with resistance or intolerance to prior therapy that includes imatinib.

The decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, which was issued on September 14. The second-generation tyrosine kinase inhibitor is now approved for these indications in all EU member states.

The agency based the decision on 2 prospective studies, which were part of a formal pediatric investigation plan, of nilotinib in children with Ph+ CML-CP.

The rate of major molecular response in patients with newly diagnosed CML was 60.0% at 12 cycles. Fifteen patients achieved MMR. The MMR rate at 12 cycles was 40.9% in previously treated patients, comprising 18 patients who achieved MMR.

By cycle 12, the cumulative MMR rates were 64.0% and 47.7% among the newly diagnosed and previously treated patients, respectively.

************************************** This week, we sat down with Dr Debu Tripathy of The University of Texas MD Anderson Cancer Center to discuss how CDK4/6 inhibitors are changing the treatment landscape of breast cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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Today-

FDA approvals in follicular lymphoma and renal cell carcinoma, a breakthrough therapy designation in multiple myeloma, promising combination results in a lung cancer trial, and a European approval in pediatric chronic myeloid leukemia.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with advanced follicular lymphoma. The indication is for patients with stage II bulky, III, or IV disease.

The approval is based on data from the international phase III GALLIUM study, in which combining obinutuzumab with chemotherapy in the first-line setting reduced the risk of disease progression or death by 28% versus rituximab plus chemotherapy in patients with follicular lymphoma.

Additional findings showed that, at a median follow-up of 41.1 months, the hazard ratio for progression-free survival by investigator assessment was 0.68. Per independent review, the HR for PFS was 0.72. The median PFS has not been reached yet in either treatment arm.

The overall response rate was 91% in the obinutuzumab arm and 88% in the control arm. Complete remission rates were 28% and 27%, respectively.

*****************************************

In renal cell carcinoma, the FDA has approved sunitinib for use as an adjuvant therapy in patients who have received nephrectomy and are high risk for recurrence.

The agency approved sunitinib for this indication despite a 6 to 6 split vote on the potential approval from its Oncologic Drugs Advisory Committee in September.

The approval is based on results from the phase III S-TRAC trial, in which adjuvant sunitinib prolonged disease-free survival by 1.2 years compared with placebo following nephrectomy for patients with high-risk clear cell RCC.

After a median follow-up of 5.4 years, the median DFS was 6.8 years in the sunitinib arm versus 5.6 years with placebo. In higher risk patients, the median DFS was 6.2 versus 4.0 years for sunitinib and placebo, respectively.

Grade 3/4 adverse events were experienced by 63.4% of patients in the sunitinib group compared with 21.7% in the placebo arm.

After 3 years, 64.9% of those in the sunitinib group were alive and remained disease-free compared with 59.5% in the placebo arm. At 5 years, the DFS rate was 59.3% with sunitinib versus 51.3% for placebo. Median overall survival findings were not yet mature at the time of the analysis; however, the hazard ratio between the two arms for survival was 1.01.

*****************************************

The FDA has granted bb2121 a breakthrough therapy designation for previously treated patients with relapsed/refractory multiple myeloma.

In a press release, the companies developing bb2121, Celgene Corporation and bluebird bio, reported that the investigational agent had also been awarded PRIority MEdicines eligibility by the European Medicines Agency. bb2121 is an anti–B-cell maturation antigen chimeric antigen receptor T-cell therapy.

The regulatory decisions were based on preliminary clinical data from the ongoing phase I CRB-401 study. The companies did not release any updated data, but noted that updating findings would be presented at the 2017 ASH Annual Meeting.

Early results presented in June 2017 showed that 75% of patients receiving the treatment demonstrated a very good partial response or better and 27% had a complete response.

The overall response across all dose levels was 89%. The median time to first response was 31 days, and the median time to best response was 50.5 days. The duration of response was 134 days and longer.

******************************

In non–small cell lung cancer, the addition of atezolizumab to bevacizumab, carboplatin, and paclitaxel was found to delay progression or death versus bevacizumab and chemotherapy alone for patients with advanced nonsquamous disease.

The topline findings were from the randomized phase III IMpower150 trial. Data from the interim analysis of the trial are being presented in December at the ESMO Immuno Oncology Congress, according to Roche, the manufacturer of both agents.

The co-primary endpoints for the IMpower150 study were progression-free survival and overall survival. Although exact numbers have not yet been released, Roche called the reduction in progression or death with the addition of atezolizumab clinically meaningful, adding that, at the interim analysis, data for overall survival were not yet mature but are encouraging.

Additionally, the company has initiated discussions with the FDA and EMA regarding regulatory approval.

**************************************

The European Commission has approved nilotinib for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, both in the frontline setting and for those with resistance or intolerance to prior therapy that includes imatinib.

The decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, which was issued on September 14. The second-generation tyrosine kinase inhibitor is now approved for these indications in all EU member states.

The agency based the decision on 2 prospective studies, which were part of a formal pediatric investigation plan, of nilotinib in children with Ph+ CML-CP.

The rate of major molecular response in patients with newly diagnosed CML was 60.0% at 12 cycles. Fifteen patients achieved MMR. The MMR rate at 12 cycles was 40.9% in previously treated patients, comprising 18 patients who achieved MMR.

By cycle 12, the cumulative MMR rates were 64.0% and 47.7% among the newly diagnosed and previously treated patients, respectively.

************************************** This week, we sat down with Dr Debu Tripathy of The University of Texas MD Anderson Cancer Center to discuss how CDK4/6 inhibitors are changing the treatment landscape of breast cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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