On October 14, 2020, the FDA approved an expanded indication for pembrolizumab for adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL or cHL that has relapsed after two or more lines of therapy. The approval was based on KEYNOTE-204, a phase III, randomized, open-label trial in 304 adult patients with relapsed or refractory cHL after at least one multiagent regimen.

Patients were randomized (1:1) to receive either pembrolizumab 200 mg every 3 weeks or brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks for up to 2 years. Efficacy was based on progression-free survival (PFS) per blinded, independent central review assessment. PFS was statistically significant longer in the pembrolizumab arm. The average PFS was 13.2 months (95% CI, 10.9, 19.4) in the pembrolizumab arm and 8.3 months (95% CI, 5.7, 8.8) in the BV arm, with a hazard ratio of 0.65 (95% CI, 0.48, 0.88; P = .0027).

Reports of serious adverse reactions occurred in 30% of the patients who received pembrolizumab. Serious adverse reactions in ≥1% of patients included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Adverse reactions in ≥20% of pembrolizumab recipients included upper respiratory tract infection, musculoskeletal pain, diarrhea, cough, pyrexia, fatigue, and rash. The study also found that 38% of patients had adverse reactions requiring systemic corticosteroids, including pneumonitis in 11%.

The recommended pembrolizumab dosage for patients with lymphoma is 200 mg every 3 weeks or 400 mg every 6 weeks IV for adults, or 2 mg/kg (up to 200 mg) every 3 weeks IV for pediatric patients, for up to 2 years.

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