New Indication for Keytruda
February 15, 2019 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck, for use as an adjuvant therapy for patients who have a significant chance of relapse after surgery to remove stage III melanoma that has spread to the lymph nodes. This is Keytruda’s second approval for treatment of melanoma. It is also indicated to treat patients who have metastatic or unresectable melanoma.
Approval for the new indication is based on a clinical study in which 71.4% of patients who received Keytruda had no recurrence for at least 18 months, compared to 61% of patients who received a placebo. Recommended dosing under the new indication is 200mg infused over the course of 30 minutes every three weeks following tumor resection. Treatment should be continued for 18 cycles, or until disease recurrence or treatment intolerance.
First FDA approved in 2014, Keytruda holds indications to treat 11 different types of cancer, including non-small cell lung cancer, classical Hodgkin lymphoma, and gastric cancer.