PEMBROLIZUMAB NEAR APPROVAL FOR HODGKIN LYMPHOMA

The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, for the treatment of patients with refractory classical Hodgkin lymphoma or for patients who have relapsed after three or more prior lines of therapy. The FDA granted Priority Review with a target action date of March 15, 2017. The sBLA will be reviewed under the FDA’s Accelerated Approval program. In April 2016, pembrolizumab was granted Breakthrough Therapy Designation by the FDA for this indication.

“Patients with refractory or relapsed classical Hodgkin lymphoma have limited treatment options,” said Roger Dansey, MD, Senior Vice President and Therapeutic Area Head, Oncology Late-Stage Development, Merck Research Laboratories. “We believe that the expedited review of this sBLA granted by the FDA is an important step in helping us make pembrolizumab available as quickly as possible to patients living with this disease.”

The application is seeking approval for pembrolizumab at a fixed dose of 200 mg administered intravenously every 3 weeks, and is based on data from the KEYNOTE-087 and KEYNOTE-013 trials, which studied patients with refractory classical Hodgkin lymphoma or who had relapsed after three or more prior lines of therapy. This is the first application for regulatory approval of pembrolizumab in a hematologic malignancy.

Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab 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.

Pembrolizumab is administered as an intravenous infusion over 30 minutes every 3 weeks for the approved indications. Pembrolizumab for injection is supplied in a 100 mg single use vial.