Today’s approval of a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated is a very big first for the cancer community. This approval provides a scientific rationale behind the goal of the RACE for Children Act — drugs developed for adult cancers should be studied for kids’ cancers regardless of the location of a tumor when they share a molecular target.
Until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers, said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence.
The drug, Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
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.
Read more on the FDA’s website: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm560167.htm