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Merck Reports the US FDA's Acceptance of Keytruda's sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma

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Merck Reports the US FDA's Acceptance of Keytruda's sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma

Merck Reports the US FDA's Acceptance of Keytruda's sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma

Shots:

  • The application is based on ORR data from cohorts D & K of KEYNOTE-158 trial evaluating Keytruda as monothx. (200 mg- q3w) in 90 patients with MSI-H/dMMR advanced EC with disease progression following prior systemic therapy in any setting & are not candidates for curative surgery or radiation
  • This indication is approved under accelerated approval- based on tumor response rate & DoR while the continuous approval is contingent on verification & description of clinical benefit in confirmatory studies
  • Keytruda + Lenvima received accelerated & full approval in Sept’19 & Jul’21 in for advanced EC respectively. The anticipated PDUFA date is Mar 28- 2022

Ref: Merck | Image: Merck

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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