Merck & Co.’s Keytruda Gets FDA Breakthrough Therapy StatusBy
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Merck & Co. Inc.’s Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This is the fourth breakthrough therapy designation granted for Keytruda.
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 was previously granted breakthrough status for specific patients with advanced melanoma, advanced non-small cell lung cancer (NSCLC), and advanced colorectal cancer.
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. It 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 for the treatment of patients with unresectable or metastatic melanoma. It is also indicated 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. The clinical development program for Keytruda includes patients with more than 30 tumor types in more than 250 clinical trials, including more than 100 trials that combine Keytruda with other cancer treatments.
In other news, the FDA has accepted for review the supplemental biologics license application (sBLA) for Keytruda for treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for Keytruda as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted priority review with a target action, date of August 9, 2016; the sBLA will be reviewed under the FDA's Accelerated Approval program.