The Food and Drug Administration on Tuesday approved a new use for Merck's best-selling cancer drug, Keytruda, based on a patient's individual genetic makeup, rather than the physical location of the tumor, reports Reuters.
Here are four things to know.
1. This approval marks the first time the agency has approved a drug for a specific patient population purely on genetic makeup.
"Until now, the FDA has approved cancer treatments based on where in the body the cancer started — for example, lung or breast cancers," Richard Pazdur, head of oncology products for the FDA's Center for Drug Evaluation and Research, told Reuters.
2. Keytruda may now be used to treat solid cancer tumors that are inoperable or that have metastasized in patients with specific genetic biomarkers. These types of tumors commonly occur in colorectal, endometrial and gastrointestinal cancers, according to the report.
3. Many industry experts believe this decision marks a major step forward for precision medicine, which uses genetic biomarkers to develop individual treatment plans for patients.
"With approval of Keytruda, FDA is leading a shift in cancer care," Jonathan Hirsch, president and founder of the San Francisco-based precision medicine technology startup Syapse, told Becker's in an emailed statement. "This is a giant leap forward for precision medicine and an encouraging sign for patients and providers."
4. The FDA approved this use of Keytruda through its accelerated approval regulations, which means continued approval for this treatment indication is contingent upon the clinical outcomes of confirmatory clinical trials.
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