Merck and Co Inc (MRK)

[DewDiligence]

FDA approves two sBLAs for Keytruda in bladder cancer:

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm

On May 18, 2017, the U.S. Food and Drug Administration granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

FDA also granted accelerated approval to pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy [emphasis added].

The PDUFA date for both approvals was 6/14/17.