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# Keytruda OK’d for Head-Neck Cancer Pre/Post-Surgery
- URL: https://www.fdaweb.com/keytruda-okd-for-head-neck-cancer-pre-post-surgery/
- Published: 2025-06-13T12:00:00.000Z
- Updated: 2026-09-14T15:14:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159355

FDA has approved Merck’s Keytruda (pembrolizumab) as the first anti‑PD‑1 therapy that can be given both before and after surgery for adults with resectable, locally advanced head and neck squamous‑cell carcinoma whose tumors express PD‑L1\. The approval allows the drug to be used as a single neoadjuvant dose, followed by adjuvant treatment alongside radiotherapy with or without cisplatin, and then continued as monotherapy.

Approval was based on data from the KEYNOTE-689 (NCT03765918) trial that evaluated event-free survival (EFS), which was defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding definitive surgery, local or distant disease progression or recurrence, or death due to any cause, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck?ref=fdaweb.com). For patients whose tumors express PD-L1, median EFS was 59.7 months in the pembrolizumab arm and 29.6 months in the control arm,” it says. Overall survival results were immature and there was no observed “trend towards a detriment,” it adds.