Posted by Michael Wonder on 01 Mar 2017
FDA accepts the biologics license application for avelumab for the treatment of metastatic urothelial carcinoma for priority review
28 February 2017 - Second biologics license application accepted by the FDA for avelumab.
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announced that the US FDA has accepted for priority review EMD Serono's biologics license application for avelumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy.
The FDA has set a Prescription Drug User Fee Act target action date of 27 August 2017, for avelumab in this indication.
