FDA Accepts Supplemental Biologics License Applications for Pembrolizumab

Merck | MSD Exhibition booth at the 2019 annual meeting of the American Society of Medical Oncology (ASCO).
Merck | MSD Exhibition booth at the 2019 annual meeting of the American Society of Medical Oncology (ASCO).

The U.S. Food and Drug Administration (FDA) has agreed to review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for pembrolizumab (Keyttuda®; Merck | known as MSD outside the United States and Canada) to include an every-six-weeks (Q6W) dosing schedule option.

Pembrolizumab is a humanized monoclonal antibody that 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.

The drug works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

Merck is seeking the approval of FDA of a 400 mg Q6W dose infused over 30 minutes for pembrolizumab indications in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma.

If approved by the FDA, the Q6W dose would be available for use in adults in addition to the currently approved dose of pembrolizumab 200 mg every three weeks (Q3W) infused over 30 minutes. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Feb. 18, 2020.

“We are committed to improving cancer care, which includes identifying ways to ensure patients have a flexible dosing option that may reduce the amount of time they spend receiving treatment,” said Scot Ebbinghaus, MD, vice president, clinical research, Merck Research Laboratories.

“If approved, the six-week dosing schedule will provide physicians and patients with greater flexibility in their treatment plans across a variety of cancer types, including melanoma where pembrolizumab is indicated in both the adjuvant and metastatic settings. We look forward to working with the FDA to file additional pembrolizumab dosing sBLAs later this year,” Ebbinghause added.

In the European Union, 400 mg Q6W dosing for pembrolizumab monotherapy was approved by the European Commission on March 28, 2019.