The U.S. Food and Drug Administration has approved Merck & Co.'s Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma who have been previously treated with ipilimumab. Pembrolizumab is of a new class of medications that target the programmed cell death 1 (PD-1) receptor.
Results of the study that lead to the approval of Keytruda were presented at the American Society of Clinical Oncology (ASCO) annual meeting earlier this year. Of 411 patients enrolled in the study, 221 had previously received ipilimumab, while 190 had not. The study tested pembrolizumab at three different dosing schedules: 10 mg/kg every 3 weeks, 2 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks. Of those enrolled in the study, 28% of those previously treated with ipilimumab experienced a response, while 40% of those not previously treated with ipilimumab had a response at 6 months or more.
Researchers found a median progression-free survival of 23 weeks for those previously treated with ipilimumab and 24 weeks for those that had not been. Furthermore, about 90% of patients did not experience side effects and only 4% discontinued the drug due to adverse effects.
Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments.
The Food and Drug Administration said it has granted accelerated approval to Merck’s Keytruda, for treating melanoma that’s spread or can’t be surgically removed, in patients previously treated with another melanoma drug called Yervoy. Experts called the news “game-changing” for patients with the deadly skin cancer, which is becoming more common and kills nearly 10,000 Americans each year.