Medication Monitor



Generic Name (Trade Name—Company)
Notes
December 27, 2018

Pembrolizumab

(Keytruda—Merck)
FDA approves pembrolizumab for Merkel cell carcinoma

FDA granted accelerated approval to pembrolizumab 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, a multicenter, nonrandomized, 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 most common adverse reactions, reported in at least 20% of patients who received pembrolizumab as a single agent, were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

The recommended dose for MCC is 200 mg administered as a 30-minute I.V. infusion every 3 weeks for adults; 2 mg/kg (to a maximum of 200 mg) administered as a 30-minute I.V. infusion every 3 weeks for patients younger than 18 years (pediatric patients).