U.S. Food and Drug Administration
December 19, 2018
On December 19, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017 (NCT02267603), a multicenter, non-randomized, open-label trial that enrolled 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease. Patients received pembrolizumab 2 mg/kg every 3 weeks.
The major efficacy outcome measures were overall response rate (ORR) and response duration assessed by blinded independent central review per RECIST 1.1. The ORR was 56% (95% CI: 41, 70) with a complete response rate of 24%. The median response duration was not reached. Among the 28 patients with responses, 96% had response durations of greater than 6 months and 54% had response durations of greater than 12 months.
The authoritative source on Merkel cell carcinoma.
May 20, 2020
- What is a Merkel cell?
- What is Merkel cell carcinoma?
- Symptoms & appearance of Merkel cell carcinoma
- Causes of Merkel cell carcinoma
- Surgical excision
- Mohs micrographic surgery
- Radiation therapy
- Complementary & alternative therapies
- Clinical trials
- Adjuvant Avelumab in Merkel Cell Carcinoma Trial