The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Keytruda® (Merck) to include an additional recommended dosage of 400mg every 6 weeks across all adult indications. The new dosing schedule is in addition to the approved dosage of 200mg every 3 weeks.
The sBLA was approved through an accelerated approval pathway based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Interim analysis of 41 patients with melanoma treated with pembrolizumab 400mg every 6 weeks showed no anticipated clinically significant differences in efficacy and safety between pembrolizumab doses of 200mg or 2mg/kg every 3 weeks or 400mg every 6 weeks. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in confirmatory trials.
“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Today’s approval of an every 6-week dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.”
Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, is indicated for the treatment of small cell lung cancer, non-small cell lung cancer, melanoma, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, non-muscle invasive bladder cancer, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, endometrial cancer, hepatocellular carcinoma, merkel cell carcinoma, and renal cell carcinoma.
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