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Bavencio FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved March 23, 2017)
Brand name: Bavencio
Generic name: avelumab
Dosage form: Injection
Company: EMD Serono, Inc.
Treatment for: Merkel Cell Carcinoma, Urothelial Carcinoma, Renal 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); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.

Development timeline for Bavencio

DateArticle
May 19, 2023Positive Results from Interim Analysis of 'GEN-001' Plus avelumab (Bavencio) Phase II Trial
Jun 30, 2020Approval FDA Approves Bavencio as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
May 14, 2019Approval  FDA Approves Bavencio (avelumab) Plus Inlyta (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma
May  9, 2017Approval FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma
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

See also

Bavencio (avelumab) Consumer information

Further information

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