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FDA Approves First Biosimilar to Treat Cancer
FDA news release; 2017 Sep 14
The FDA has approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer.
Indications: Mvasi is a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of metastatic colorectal cancer (mCRC), non-squamous non-small cell lung cancer (NSCLC), glioblastoma, metastatic renal cell carcinoma (mRCC), and cervical cancer.
Dosage and administration:
- mCRC: 5 mg/kg IV every 2 weeks with bolus-IFL; 10 mg/kg IV every 2 weeks with FOLFOX4; 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy.
- Non-squamous NSCLC: 15 mg/kg IV every 3 weeks with carboplatin/paclitaxel.
- Glioblastoma: 10 mg/kg IV every 2 weeks.
- mRCC: 10 mg/kg IV every 2 weeks with interferon alfa.
- Cervical cancer: 15 mg/kg IV every 3 weeks with paclitaxel/cisplatin or paclitaxel/topotecan.
Efficacy and safety: Approval is based on evidence showing that Mvasi is biosimilar to Avastin.
Side effects/risks: Most common adverse reactions are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.
FDA approves first biosimilar for the treatment of cancer [news release]. Silver Spring, MD: FDA. September 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm. Accessed September 16, 2017.
Mvasi [package insert]. Thousand Oaks, CA: Amgen, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761028s000lbl.pdf. Accessed September 16, 2017.