Bavencio Approval History
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 History and FDA Approval Process for Bavencio
|May 14, 2019|| FDA Approves Bavencio (avelumab) Plus Inlyta (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma|
|May 9, 2017|| FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma|
|Mar 23, 2017|| FDA Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma|
|Feb 28, 2017||FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review|
|Nov 29, 2016||FDA Accepts the BLA for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review|
|Jul 6, 2016||Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer|
|Jun 6, 2016||ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma|
|Jan 4, 2016||Merck, Pfizer and Syndax Announce Collaboration to Evaluate Combination of Avelumab and Entinostat in Ovarian Cancer|
|Nov 18, 2015||Merck and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma|
|Nov 4, 2015||Merck 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, 2015||Merck and Pfizer Initiate Phase III Study with Avelumab in Patients with Stage IIIb/IV Non-Small Cell Lung Cancer|
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