Merck’s Keytruda Gets Breakthrough Therapy for Colorectal Cancer
Merck known as MSD outside the United States and Canada, today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. This is the third breakthrough therapy designation granted for Keytruda. Keytruda was previously granted breakthrough status for advanced melanoma and advanced non-small cell lung cancer (NSCLC).
The FDA's breakthrough therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Keytruda is also indicated at the same dosing for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Source: Merck & Co. Inc.