FDA Approves Keytruda for Cancers with Specific Biomarker

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This marks the first FDA approval of a treatment based on a specific biomarker.

On May 23, 2017, FDA approved Merck’s blockbuster cancer drug Keytruda (pembrolizumab) for the treatment of cancers with a specific biomarker. This new approval marks the first-time FDA has approved a treatment based on a common biomarker, as opposed to the location in the body where the tumor originated.

“This is an important first for the cancer community,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “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.”

In clinical trials, of the 149 patients who received the drug, 39.6% had a complete or partial response. For 78% of these patients, the response lasted for six months or more, FDA wrote.


Keytruda is approved for other indications including melanoma and non-small cell lung cancer, among others. The drug was listed as a topic selling drug in Merck’s 2016 full-year financial results.

Source: FDA, Merck