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# Merck’s Keytruda Gains Approval for Cancers with Biomarker
- URL: https://www.fdaweb.com/mercks-keytruda-gains-approval-for-cancers-with-biomarker/
- Published: 2017-05-23T12:00:00.000Z
- Updated: 2026-09-14T22:25:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138762

FDA has granted Merck accelerated approval for Keytruda (pembrolizumab) for treating patients whose cancers have a specific genetic feature (biomarker). “This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated,” an [FDA release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm560167.htm?ref=fdaweb.com) says. The agency previously approved Keytruda for treating certain patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.  
  
Keytruda is now indicated for treating adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker (microsatellite instability-high (MSI-H) or mismatch repair deficient). “This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs,” the agency says.  
  
“This is an important first for the cancer community,” FDA Oncology Center of Excellence director **Richard Pazdur** is quoted in the release as saying. “Until now, the FDA has approved cancer treatments based on where in the body the cancer started — for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”  
  
Approval was based on data from five uncontrolled, single-arm clinical trials involving 149 patients with one of 15 cancer types. “The review of Keytruda for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response),” FDA says. “Of the 149 patients who received Keytruda in the trials, 39.6% had a complete or partial response. For 78% of those patients, the response lasted for six months or more.”