Shots:

• The approval is based on KEYNOTE-057 (NCT02625961) study involves assessing of Keytruda (200 mg- q3w) in 96 patients with BCG-unresponsive- high-risk- non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with/out papillary tumors who are ineligible for or have elected not to undergo cystectomy
• The study resulted in median follow-up time 28 mos.- CRR 41%- mDOR 16.2 mos.- 46% has response of 12 mos. or longer
• Merck & Co’s (MSD outside the United States and Canada) Keytruda is a mAb blocking the interaction between PD-1 and its ligands- PD-L1 & PD-L2- activating the T lymphocytes and is evaluated in 950+ trials for multiple indications

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Ref: Merck | Image: Merck