Merck & Co’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Patients with BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer

Merck’s (KEYTRUDA in combination with ALIMTA and Pt CT) Receives EU Approval for 1L mNonsq NSCLC with no EGFR or ALK Genomic Tumour


  • 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

Click here to read full press release/ article | Ref: Merck | Image: Twitter