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Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA approves pembrolizumab for relapsed/refractory PMBCL

FDA Press Announcement, June 15, 2018; Keytruda Prescribing Information (Drugs@FDA)

The FDA has approved (pembrolizumab) Keytruda for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL).

Indications: Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody is indicated for the treatment of adult and pediatric patients with refractory PMBCL or who have relapsed after 2 or more prior lines of therapy. It is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Keytruda also is indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.

Dosage and administration: For adults, the recommended dose is 200 mg every 3 weeks. In pediatric patients, the recommended dose is 2 mg/kg every 3 weeks, with a maximum dose of 200 mg.

Efficacy and safety: Based on a multicenter, open-label, single-arm trial of 53 patients with relapsed or refractory PMBCL (KEYNOTE-170; NCT02576990), the overall response rate was 45%, with 11% of patients seeing a complete response and 34% seeing a partial response.

Side effects/risks: The most common adverse reactions to pembrolizumab were musculoskeletal pain, upper respiratory tract infection, pyrexia, fatigue, cough, dyspnea, diarrhea, nausea, arrhythmia, and headache. In total, a quarter of patients with adverse reactions required systemic treatment with a corticosteroid and 26% of patients had serious adverse reactions.


FDA Press Announcement, June 15, 2018

Keytruda Prescribing Information (Drugs@FDA)

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