Avelumab BLA accepted for Priority Review by FDA

The US FDA has accepted for Priority Review the Biologics License Application (BLA) for avelumab, as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy, according to the drug’s developers, Germany’ Merck KGaA (MRK: DE) and US pharma giant Pfizer (NYSE: PFE).

The BLA was submitted by EMD Serono, the biopharmaceutical business of Merck in the USA and Canada. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2017, for avelumab in this indication.

Despite advances in the treatment of urothelial carcinoma, the prognosis for patients remains poor, particularly when the disease has metastasized.Bladder cancer makes up approximately 90% of urothelial cancers and is the sixth most common cancer in the US.