FDA Expands Approval of Pembrolizumab to Include New Lymphoma Indication

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or those who have relapsed after two or more prior lines of therapy.


Approval was based on data from 53 patients with relapsed or refractory primary mediastinal large B-cell lymphoma enrolled in a multicenter, open-label, single-arm trial, KEYNOTE-170. Patients were treated with pembrolizumab at 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression or for up to 24 months for patients without disease progression.

The overall response rate was 45% (95% confidence interval [CI] = 32%–60%), including 11% complete responses and 34% partial responses. The median duration of response was not reached within the follow-up period (median = 9.7 months). The median time to first objective response was 2.8 months. Pembrolizumab is not recommended for the treatment of patients with primary mediastinal large B-cell lymphoma who require urgent cytoreductive therapy.

The most common adverse reactions in ≥ 10% of patients treated in KEYNOTE-170 were musculoskeletal pain, upper respiratory tract infection, pyrexia, fatigue, cough, dyspnea, diarrhea, abdominal pain, nausea, arrhythmia, and headache. Pembrolizumab was discontinued or interrupted due to adverse reactions in 8% and 15% of patients, respectively. About 25% of patients had an adverse reaction requiring systemic corticosteroid therapy. Serious adverse reactions occurred in 26% of patients.

The recommended pembrolizumab dose for treatment of adults with primary mediastinal large B-cell lymphoma is 200 mg every 3 weeks.  The recommended dose in pediatric patients is 2 mg/kg (up to a maximum of 200 mg) every 3 weeks.

Pembrolizumab prescribing information is available at: https://www.keytruda.com/hcp/dosing/.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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