The U.S. Food and Drug Administration (FDA) has granted the accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
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). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.
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.
Despite having some side effects, Keytruda would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm560167.htm
