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Merck’s KEYTRUDA Wins Expanded Approval in Non-Small Cell Lung Cancer

With this approval, KEYTRUDA is the only immunotherapy with an approved option for NSCLC regardless of PD-L1 expression.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Merck received approval from the FDA for KEYTRUDA, an anti-PD-1 therapy, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB, II, or IIIA non-small cell lung cancer (NSCLC).   The approval is based on data from the pivotal Phase 3 KEYNOTE-091 trial. The major efficacy outcome measure was investigator-assessed disease-free survival (DFS). In patients who received adjuvant platinum-based chemotherapy following su...

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