FDA Will Review Application Seeking Expansion of Keytruda’s Dosing Schedule

The U.S. Food and Drug Administration (FDA) has accepted for review six supplemental biologics license applications (sBLAs) seeking to expand the dosing schedule of Keytruda (pembrolizumab) so the medication can be administered every six weeks.

Keytruda is a checkpoint blockade immunotherapy developed by Merck (known as MSD outside the U.S. and Canada), which has been approved by the FDA and the European Medicines Agency (EMA) for treating several types of cancer.

It is a monoclonal antibody that has been designed to target and block the activity of the PD-1 receptor (a protein found on the surface of immune cells), preventing cancer cells from avoiding being targeted and killed by immune cells.

The company now is seeking to expand the dosing schedule of Keytruda, so that the medication can be administered at a dose of 400 mg every six weeks, in addition to the current dosing regimen of 200 mg every three weeks, in patients with melanoma, classical Hodgkin’s lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma, and Merkel cell carcinoma.

If approved, adult patients living in the U.S. soon will have the option to decide which dosing schedule of Keytruda they prefer.

“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,” Scot Ebbinghaus, vice president of clinical research at Merck Research Laboratories, said in a press release.

“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 Keytruda is indicated in both the adjuvant and metastatic settings. We look forward to working with the FDA to file additional Keytruda dosing sBLAs later this year,” he added.

The FDA has signed a Prescription Drug User Fee Act (PDUFA) dated Feb. 18, 2020. By then, the agency must decide whether the dosing schedule for Keytruda should be expanded for all these indications.

On March 28, 2019, the European Commission approved the same dosing schedule for Keytruda for all its current monotherapy indications in the European Union.