First Biosimilar for the Treatment of Cancer Approved by FDA
By: Susan Reckling
Posted: Friday, September 15, 2017
Yesterday, 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. It is the first biosimilar approved in the U.S. for the treatment of cancer.
Bevacizumab-awwb is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney, and cervical cancers. Specifically, the approved indications include:
- Nonsquamous non–small cell lung cancer, in combination with carboplatin and paclitaxel, for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease
- Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment or in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin–based chemotherapy for second-line treatment of patients whose disease has progressed on a first-line bevacizumab product–containing regimen
- Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate
- 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
Common expected side effects of bevacizumab-awwb include nose bleeds, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, excessive tear production, back pain, and skin irritation.
The FDA's approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate Mvasi is biosimilar to Avastin.