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Bavencio Approval History

Reviewed on Mar 23, 2017 by J.Stewart BPharm
  • 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

Mar 23, 2017Approval FDA Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma
Feb 28, 2017FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review
Nov 29, 2016FDA Accepts the BLA for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review
Jul  6, 2016Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer
Jun  6, 2016ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma
Jan  4, 2016Merck, Pfizer and Syndax Announce Collaboration to Evaluate Combination of Avelumab and Entinostat in Ovarian Cancer
Nov 18, 2015Merck and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma
Nov  4, 2015Merck and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer
Apr 20, 2015Merck and Pfizer Initiate Phase III Study with Avelumab in Patients with Stage IIIb/IV Non-Small Cell Lung Cancer

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