EMD Serono, the biopharmaceutical business of Merck KGaA and Pfizer Inc., received U.S. Food and Drug Administration Priority Review approval of its Biologics License Application (BLA) for avelumab.
"Taken together with last year's filing for metastatic Merkel cell carcinoma, this BLA acceptance confirms our rapid and continued progress in the clinical development of avelumab," Dr. Luciano Rossetti, executive vice president of Merck KGaA, said in a statement. "We continue to evaluate avelumab in cancers that have limited or suboptimal treatment choices, such as metastatic or locally advanced urothelial carcinoma, to hopefully be able to provide patients with new treatment options for fighting their disease."
Avelumab, an investigational, fully human anti-PD-L1 antibody, is a potential treatment for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy. It is not yet approved in any indication in any market, but is moving forward with phase III studies.
The FDA set a Prescription Drug User Fee Act target action date of Aug. 27.