Bavencio Approval History
- FDA approved: Yes (First approved March 23rd, 2017)
- Brand name: Bavencio
- Generic name: avelumab
- Dosage form: Injection
- Company: EMD Serono, Inc.
- Treatment for: Merkel Cell Carcinoma
Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC).
Bavencio was granted accelerated approval by the FDA based on results of the JAVELIN Merkel 200 trial, an open-label, single-arm, multi-center study conducted in 88 patients with metastatic MCC. Of the patients who received Bavencio, 22 percent experienced partial shrinkage of their tumors, while 11 percent experienced complete shrinkage. The response lasted more than six months in 86 percent of patients, and more than 12 months in 45 percent of patients.
Bavencio is administered as an intravenous infusion over 60 minutes every two weeks. To reduce the risk of serious infusion-related reactions, patients should be premedicated with an antihistamine and acetaminophen for the first four doses, and thereafter as required. Bavencio carries warnings for immune-mediated reactions, which may be serious. Common side effects include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema.
Development History and FDA Approval Process for Bavencio
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