FDA Approves Additional Recommended Dose of Keytruda for SCLC
The U.S. Food and Drug Administration has approved an additional recommended dosage of 400 mg at every 6 weeks for Keytruda (pembrolizumab), according to a press release. The new 6-week dosing is for all approved adult indications.
“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 in a press release. “Today’s approval of an every six-week dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.”
Keytruda is indicated for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Read the full press release here.