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FDA Grants Accelerated Approval of Drug for Primary Mediastinal Large B-Cell Lymphoma


June 13, 2018

The US Food and Drug Administration granted accelerated approval of a drug for the treatment of adult and pediatric patients with primary mediastinal large B-cell lymphoma (PMBCL).

Keytruda (pembrolizumab, Merck) is now approved for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. 

This approval was based on the multicenter, open-label, single-arm KEYNOTE-170 trial. Fifty-three patients with relapsed or refractory PMBCL were enrolled and treated with Keytruda 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression for up to 24 months. The overall response rate was 45%, including 11% complete responses and 34% partial responses.

The most common adverse reactions, occurring in 10% or less of patients were musculoskeletal pain, upper respiratory tract infection, pyrexia, fatigue, cough, dyspnea, diarrhea, abdominal pain, nausea, arrhythmia, and headache. Keytruda was discontinued or interrupted due to adverse reactions in 8% and 15% of patients, respectively. A total of 25% of patients had an adverse reaction requiring systemic corticosteroid therapy. Serious adverse reactions occurred in 26% of patients.

This indication was approved under accelerated approval based on tumor response rate and durability of response.

—Janelle Bradley


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