The FDA granted accelerated approval to Keytruda, an adult and pediatric treatment for unresectable or metastatic solid tumors identified as having a biomarker.
Here's what you should know.
1. This is the first time the FDA approved a cancer treatment based on a common biomarker.
2. The approval covers patients with solid tumors that continue to progress despite prior treatments or for patients with no satisfactory alternative treatments.
3. FDA Center for Drug Evaluation and Research Office of Hematology and Oncology Products Acting Director Richard Pazdur, MD, said in a release, "This is an important first for the cancer community. 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."
4. Colorectal, endometrial and gastrointestinal cancers all have tumors with biomarkers. Keytruda targets cellular pathways. By blocking the pathways, the body's immune cells can target cancer cells.