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# Merck gets Accelerated OK for Keytruda in Lung Cancer
- URL: https://www.fdaweb.com/merck-gets-accelerated-ok-for-keytruda-in-lung-cancer/
- Published: 2019-06-18T12:00:00.000Z
- Updated: 2026-09-15T01:33:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144365

FDA has granted Merck accelerated approval for Keytruda (pembrolizumab) and its use in treating patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The anti-PD-1 therapy’s approval was based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company says. Keytruda is already an established treatment option for non-small cell lung cancer. 

In clinical trials, Keytruda demonstrated an objective response rate of 19%, a complete response rate of 2% and a partial response rate of 17%, according to the company. Among the 16 responding patients, 94% had a duration of response of six months or longer, 63% had 12 months or longer and 56% had 18 months or longer. Responses ranged from 4.1 to 35.8 months.