(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, which is set to lose certain U.S. patents towards the end of the decade, had sales of $12.1 billion in the last two quarters.
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.
The drug is already approved as a follow-up treatment for adult patients with early stages of NSCLC after chemotherapy and surgery.
Earlier in October, Merck reported that Keytruda also met its second primary goal of overall survival among NSCLC patients in the late-stage study, building its case for use of the drug in the patient population.
The Keytruda/chemotherapy combination, when given before surgery, helped patients live longer without the disease compared to only chemotherapy.
Merck, earlier in the day, also reported that the European Commission has approved Keytruda as a follow-up treatment for adult NSCLC patients who are at a high risk of the disease returning after complete resection and chemotherapy.
(Reporting by Shivani Tanna and Pratik Jain in Bengaluru; Editing by Shinjini Ganguli and Shailesh Kuber)
