The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL).

The approval was based on data from the KEYNOTE-170 study, a multicenter, open-label, single-arm trial that included 53 patients with relapsed or refractory PMBCL. Patients were treated with Keytruda 200mg IV every 3 weeks until unacceptable toxicity or documented disease progression, or for up to 24 months for patients who did not progress; efficacy was based on overall response rate (ORR) and duration of response.

Results showed that for the 24 responders, the median time to first objective response (complete or partial response) was 2.8 months (range: 2.1 to 8.5 months); median follow-up time was 9.7 months. The ORR was 45% (11% complete response, 34% partial response) while median duration of response was not reached (range: 1.1+ months to 19.2+ months). 

“Relapsed or refractory PMBCL is often a challenging disease to treat, and many affected patients are young adults,” said Philippe Armand, MD, PhD, medical oncologist in the Hematologic Oncology Treatment Center at Dana-Farber Cancer Institute. “In the clinical trial that supported this approval, treatment with Keytruda resulted in meaningful responses, including complete disease remission in some patients. This approval therefore provides another therapeutic option for patients with PMBCL who have progressed on or after prior therapies.”

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Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, is also approved for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell cancer,  classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.

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