FDA Recent Approvals Include First Oncology Biosimilar


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ON SEPTEMBER 14, 2017, the U.S. Food and Drug Administration (FDA) approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the United States for the treatment of cancer. 

Scott Gottlieb, MD

Scott Gottlieb, MD

“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower health-care costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, MD. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.” 

Approved Indications 

BEVACIZUMAB-AWWB is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney, and cervical cancers. Specifically, the approved indications include: 

  • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. Bevacizumab-awwb is not indicated for the adjuvant treatment of surgically resected colorectal cancer. 
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin–based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product– containing regimen. Bevacizumab-awwb is not indicated for the adjuvant treatment of surgically resected colorectal cancer. 
  • Nonsquamous non–small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease. 
  • Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data are available demonstrating improvement in disease-related symptoms or survival with bevacizumab products. 
  • Metastatic renal cell carcinoma, in combination with interferon alfa. 
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. 

Health-care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Visit FDA.gov for the full report. 

FDA Approves Copanlisib 

COPANLISIB (ALIQOPA) received accelerated approval for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. 

Copanlisib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm copanlisib’s clinical benefit, and the sponsor is currently conducting these studies. 

CHRONOS-1 

THE FDA’S approval of copanlisib was based on data from the CHRONOS-1 trial, a single-arm study that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. The trial measured overall response rate. In the trial, 59% of patients had a complete or partial response for a median 12.2 months. 

Common side effects of copanlisib include hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia. 

Serious side effects include infections, hyperglycemia, hypertension, noninfectious pneumonitis, neutropenia, and severe skin reactions. Women who are pregnant or breastfeeding should not take copanlisib because it may cause harm to a developing fetus or newborn baby. ■



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