RE:Total Time to Accelerated Approval (Months)First time I see this. For BCG-Unresponsive, Merck obtained the Accelerated Approval.
In 0.5 month!
BLA 125514 Supplement 79 4
KEYTRUDA
PEMBROLIZUMAB
MERCK SHARP & DOHME
4/14/2020
4/28/2020
0.5
PROVIDES FOR AN ALTERNATE DOSE/SCHEDULE OF 400MG EVERY 6 WEEKS FOR ADULT PATIENTS WITH BCG-UNRESPONSIVE, HIGH RISK, NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) WITH CARCINOMA IN-SITU (CIS) WITH OR WITHOUT PAPILLARY TUMORS WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY