PD-L1 drug Bavencio gains bladder cancer approval

FDA granted accelerated approval to Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) to treat locally advanced or metastatic urothelial carcinoma. Specifically, the PD-L1-targeted mAb is indicated for patients with disease progression during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, regardless of PD-L1 status.

The approval came more than three months ahead of Bavencio's Aug. 27 PDUFA date in the indication...