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

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 Ref: Merck | Image: Merck