Keytruda Receives New Indication for Merkel Cell Carcinoma

December 19, 2018 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck. Under the new indication, Keytruda is now approved to treat of adult and pediatric patients who have recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

A rare and aggressive form of skin cancer, Merkel cell carcinoma affects fewer individuals than melanoma, but has a higher rate of mortality. Approximately one in three patients diagnosed with MCC will die, compared to one in nine patients diagnosed with melanoma. The disease is highly metastatic and prone to recurrence. Approximately 700 U.S. patients diagnosed with MCC die of the disease annually, and an estimated 2,500 new cases are identified each year.

Keytruda achieved an overall response rate of 56% in patients with MCC in a clinical trial, as well as a complete response rate of 24%, and a partial response rate of 32%. Of patients who responded to treatment, 96% experienced a duration of response that lasted for six months or longer. More than half (54%) had a duration of response lasting at least 12 months.

Recommended dosing under the new indication is 200mg for adults and 2mg/kg for pediatric patients (up to a maximum dose of 200mg) administered via intravenous (IV) infusion over the course of 30 minutes every three weeks. Treatment can continue until disease progression or unacceptable toxicity, up to a maximum of 24 months.

First approved in 2014, Keytruda now holds indications to treat 11 different types of cancer.