Posted by Michael Wonder on 13 Jun 2022
FDA accepts application for Merck’s Keytruda (pembrolizumab) as adjuvant therapy for stage IB (≥4 cm)-IIIA non-small-cell lung cancer following complete surgical resection
13 June 2022 - Acceptance based on results from the Phase 3 KEYNOTE-091 trial, the seventh positive pivotal trial evaluating a Keytruda based regimen in earlier stages of cancer.
Merck today announced the U.S. FDA has accepted for review a new supplemental biologics license application seeking approval for Keytruda for the adjuvant treatment of patients with stage IB (≥4 cm, II or IIIA non-small cell lung cancer following complete surgical resection.
