(Reuters) -The U.S. Food and Drug Administration on Monday approved the expanded use of Merck & Co’s blockbuster immunotherapy Keytruda in early-stage patients with non-small cell lung cancer who can get their tumors removed surgically.
The U.S. health regulator’s approval extends Keytruda’s use in combination with chemotherapy as a treatment given before surgery to shrink the size of the tumor in patients.
The decision also allows use of the drug as a follow-up treatment after surgery.
The U.S. drugmaker is aiming to widen use of Keytruda, used as a second line of treatment in some cancer patients, into earlier lines of treatment. The drug is set to lose certain U.S. patents towards the end of the decade.
Merck’s application to the agency for expanded use was based on data from a late-stage trial in which Keytruda met one of the dual primary study goals of event-free survival (EFS), or the period of time a patient remains free of disease and related complications.
Keytruda, Merck’s top selling product which is approved in multiple indications worldwide, helps the body’s own immune system fend off cancer by blocking a protein called PD-1.
(Reporting by Shivani Tanna and Pratik Jain in Bengaluru; Editing by Shinjini Ganguli and Shailesh Kuber)
