Merck’s Keytruda (pembrolizumab) Receives FDA’s Priority Review for sBLA to Treat High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Merck’s Zerbaxa (ceftolozane and tazobactam) Receives FDA’s Approval for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia in Adults

Shots:

  • The application is based on P-II KEYNOTE-057 trial which involves assessing of Keytruda (200mg, q3w) in 102 patients with BCG unresponsive, high-risk NMIBC with carcinoma in-situ (CIS) with/out papillary tumors who were ineligible for or had elected not to undergo cystectomy
  • The results of P-II KEYNOTE-057 is expected to disclose in FDA’s Oncologic Drugs Advisory Committee (ODAC) on Dec 17, 2019, and will also be presented at European Society for Medical Oncology 2018 Congress
  • 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. The company is expecting PDUFA date as Jan 2020 based on priority review

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