Merck (MRK) said Tuesday that the US Food and Drug Administration has granted priority review for its new supplemental biologics application for Keytruda, in combination with standard of care, as perioperative treatment for patients with resectable locally advanced head and neck squamous cell carcinoma.
The company said the application was based on data from a phase 3 trial, where the combination therapy demonstrated "statistically significant" improvement in event-free survival and in major pathological response. Merck said results from the first interim analysis of trial data is set to be released at an upcoming medical meeting.
According to the company, the FDA has set a target action date of June 23 for the application.
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