FDA grants Priority Review to avelumab

The FDA will decide over second-line use of the anti-PDL1-antibody on 27 August. Prior to that, the Agency will decide over the BLA of avelumab in the rare skin cancer metastatic Merkel cell carcinoma in May. Avelumab is in Phase III testing for certain other cancers, including, renal cell carcinoma, non-small cell lung cancer (NSCLC), and gastric  and ovarian cancers

“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,” said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at EMD Serono, the biopharma business of Merck. “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.”

Competition in the field, however, is fierce as Roche’s PDL1 inhibitor atezolizumab as well as Bristol Myers Squibb’s PD1 blocker nivolumab received accelerated approval as second-line treatment in urothelial carcinoma in May and October 2016, respectively. While Roche’s application was approved before the Prescription Drug User Fee Act (PDUFA) goal date of September 12, 2016, the PDUFA date for BMS’ PD-1 inhibitor is March 2, 2017.

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