September 29, 2023
The FDA approved Keytruda for a range of cancers with a common biomarker. At right, Dr. Thomas George, associate director of clinical investigation at University of Florida Health Cancer Center.

Cancer Care

Wider Approval

The FDA takes a broader approach to approving drug therapy.

Amy Martinez | 2/27/2018

Historically, the FDA has approved cancer drugs based on a particular cancer’s location in the body, but that may be changing.

Last year, the FDA said Keytruda, a new immunotherapy drug by Merck, could be used to treat all cancers that share a genetic abnormality called mismatch repair (MMR) deficiency. It was the first time the FDA approved a cancer drug based on a common biomarker rather than the cancer type — lung vs. breast, for example. Keytruda itself previously had been approved for patients with metastatic lung, neck and skin cancers.

The immunotherapy targets proteins on T-cells that prevent a patient’s immune system from recognizing and attacking cancer cells. By blocking these proteins, Keytruda aims to increase the im- mune system’s ability to home in on cancer cells without harming normal, healthy tissue. About 40% of cancer patients who received Keytruda in clinical trials saw their tumors shrink or disappear.

Doctors estimate that 4% of all cancers are MMR deficient, potentially making 60,000 patients a year eligible for the infused drug, which costs about $150,000 a year.

“At some point in the future — and it may be past my lifetime — if the immune system can be harnessed safely and effectively, there should be no need for surgery, radiation and traditional chemotherapy,” says Dr. Thomas George, associate director of clinical investigation at University of Florida Health Cancer Center. “The cancer should be permanently destroyed by a patient’s own immune system.”


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Tags: Government/Politics & Law, Healthcare, Life Sciences, Research & Development, Technology/Innovation, Cancer Care, Economic Backbone

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