On September 26, 2024, the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the risk-benefit assessment of Keytruda in combination with chemotherapy for first-line treatment of certain advanced gastric, gastroesophageal junction (GEJ), and esophageal cancers.
The committee did not find the risk-benefit assessment favorable for the subset of patients with PD-L1 <1 in certain advanced HER2-negative gastric and advanced esophageal squamous cell cancers. Merck expressed disappointment with this outcome, noting limited first-line treatment options beyond chemotherapy for these patients.
Merck stated its support for retaining the current approved indications, which reflect results from global Phase 3 trials across all PD-L1 expression levels. The company plans to continue discussions with the FDA to ensure continued access to Keytruda for appropriate patients, as the FDA is not bound by the committee's recommendations.
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