FDA approves additional recommended dosage for Keytruda
The FDA approved an additional recommended dosage of pembrolizumab, authorizing its use at 400 mg every 6 weeks.
The new dosage option — available in addition to the previously approved dose of 200 mg every 3 weeks — applies to all adult indications for pembrolizumab (Keytruda, Merck).
The anti-PD-1 therapy is approved for use as monotherapy and as part of combination therapy for multiple cancer types.
“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a company-issued press release. “[This] 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.”
The FDA has approved pembrolizumab for treatment of specific patients with melanoma, lung cancer, head and neck squamous cell carcinoma, lymphoma, urothelial carcinoma, bladder cancer, renal cell carcinoma gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma and microsatellite instability-high cancers.