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Avelumab Approval Status

  • FDA approved: No
  • Generic name: avelumab
  • Company: EMD Serono, Inc.
  • Treatment for: Merkel Cell Carcinoma

Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody in development for the treatment of metastatic Merkel cell carcinoma.

Development Status and FDA Approval Process for avelumab

DateArticle
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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