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...
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.
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 , or the period of time a patient remains free of disease and related complications. Morningstar analyst Damien Conover expects the early-line lung cancer setting to be competitive with Bristol-Myers Squibb's Opdivo, Roche's Tecentriq and AstraZeneca PLC Imfinzi, all looking to gain approvals in the early-stage setting.
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