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.
This Week's Must Reads
Must Reads in FDA Actions
Stereotactic Radiotherapy System Approved For BC, FDA news release; 2017 Dec 22
Perjeta Approved for Certain Type of Early BC, Genentech news release; 2017 Dec 20
Bosulif Approved to Treat Newly-Diagnosed Ph+ CML, Avillion news release; 2017 Dec 19
FDA Approves Nucala to Treat Vasculitis, FDA news release; 2017 Dec 12
FDA Approves Hemlibra to Prevent Bleeding, FDA news release; 2017 Nov 9