FDA Approves First Biosimilar to Fight Cancer

In September, the U.S. Food and Drug Administration (FDA) approved the first biosimilar drug to treat cancer. Mvasi (bevacizumab-awwb) was approved as a biosimilar to Avastin (bevacizumab) for the treatment of adults with certain colon, lung, brain, kidney and cervical cancers. Specifically, the approved indications include:

• metastatic colorectal cancer in combination with IV 5-fluorouracil-based chemotherapy for first- or second-line treatment;
• metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecanorfluoropyrimidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen;
• 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 after prior therapy, based on improvement in objective response rate (no data available demonstrating improvement in disease-related symptoms/survival with bevacizumab products);
• metastatic renal cell carcinoma, in combination with interferon alfa; and
• cervical cancer that is persistent, recurrent or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

Mvasi is marketed by Amgen. Like Avastin, the labeling for Mvasi has a boxed warning about an increased risk of holes in the stomach and intestines; surgery and wound-healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding. Common side effects include nosebleeds, headache, high blood pressure, inflammation of the nasal cavity, high levels of protein in the urine, taste alteration, dry skin, rectal bleeding, excessive tear production, back pain and skin irritation. In addition, women who are pregnant should not take Mvasi because it may cause harm to a developing fetus.