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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.

Citation:

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.