FDA accepts two sBLAs for MSD’s Keytruda

MSD announced that FDA has granted Priority Review for two sBLAs (supplemental Biologics License Application) for Keytruda (pembrolizumab), an anti-PD-1 treatment for patients with metastatic or locally advanced urothelial carcinoma. The sBLAs refer to the use of the product as a first-line treatment for patients within this population and who cannot be treated through cis-platinum therapy and as a second-line treatment for those patients who have already received a platinum therapy or whose disease has progressed. FDA has also granted a Priority Review in both cases. The two applications are based on the results from the Phase II KEYNOTE-052 and the Phase III KEYNOTE-045 trials.
(Source Business Wire)