Merck Reports the US FDA’s sBLA Acceptance of Neoadjuvant Keytruda with Priority Review for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Shots:
- The US FDA has accepted sBLA & granted priority review to neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy ± cisplatin & then as a single agent to treat operable LA-HNSCC (PDUFA: Jun 23, 2025)
- sBLA was based on P-III (KEYNOTE-689) trial data assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (200mg, IV, Q3W × 15 cycles) + SoC radiotherapy ± cisplatin (100mg/m^2, IV, Q3W × 3 cycles) vs adj. SoC radiotherapy without cisplatin in treatment-naïve pts (n=704) with operable stage III/IVA LA-HNSCC
- Interim analysis showed that improved EFS (1EP) & mPR (2EP) in comparison to SoC therapy. Data to be highlighted at future conferences
Ref: Merck | Image: Merck
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
