FDA Approves First Drug for Cancer Treatment Based on Common Biomarkers

"This is an important first for the cancer community," said Dr. 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 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."

The U.S. Food and Drug Administration granted accelerated approval last week to a treatment for patients whose cancers have a specific genetic feature, and Johns Hopkins also reported the news because the drug, Keytruda (pembroluzimab), was developed from 30 years of basic research at Johns Hopkins and its Bloomberg–Kimmel Institute, Vanessa Wasta reported.

The drug can be used for colon, pancreatic, stomach, ovarian, and other cancers in adult and pediatric patients if genetic testing reveals defects in mismatch repair genes, she reported, with FDA saying 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.

FDA granted accelerated approval of Keytruda to Merck & Co. "Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body's immune system fight the cancer cells. The FDA previously approved Keytruda for the treatment of 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," the agency announced.

"This is an important first for the cancer community," said Dr. 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 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."

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