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
Related News:- Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma
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