By Dean Seal

 

Merck & Co. Inc. is seeking the U.S. Food and Drug Administration's approval for its drug Keytruda to be used as an adjuvant treatment for patients with stage IB, II or IIIA non-small cell lung cancer following a complete surgical resection.

The company said Monday that the FDA has accepted and will review its supplemental biologics license application for Keytruda, which is based on a pivotal Phase 3 trial evaluating the drug against a placebo that showed a significant improvement in disease-free survival for lung cancer patients regardless of their PD-L1 expression.

The trial, which is being conducted in collaboration with the European Organisation for Research and Treatment of Cancer and the European Thoracic Oncology Platform, will continue analyzing disease-free survival for patients whose tumors express high levels of PD-L1, Merck said.

The FDA has set Jan. 29, 2023 as the target date to respond to Merck's biologics license application, though further data provided during the review process may delay that.

 

Write to Dean Seal at dean.seal@wsj.com

 

(END) Dow Jones Newswires

June 13, 2022 07:53 ET (11:53 GMT)

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