Merck Receives the US FDA Advisory Committee’s Recommendation on Approval of Keytruda (pembrolizumab) for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

 Merck Receives the US FDA Advisory Committee’s Recommendation on Approval of Keytruda (pembrolizumab) for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

Merck Receives the US FDA Advisory Committee’s Recommendation on Approval of Keytruda (pembrolizumab) for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

Shots:

  • The US FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 9-4 in favor of recommending Keytruda for bacillus Calmette-Guérin-unresponsive, high risk NMIBC with carcinoma in-situ with/ out papillary tumors who are ineligible for or have elected not to undergo cystectomy
  • The ODAC recommendation is based on the results of P-II KEYNOTE-057 study and supports the potential of Keytruda as monothx. to treat patients with NMIBC. Merck expects PDUFA date in Jan’2020, based on priority review
  • The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational therapies for use in the treatment of cancer

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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