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FDA Extends Approval of Pembrolizumab for Classical Hodgkin Lymphoma

Oncology Practice Insider

On October 14, 2020, the Food and Drug Administration extended the approval of pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme Corp.) for the following indications: 

  • adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and
  • pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Approval was based on KEYNOTE-204 (NCT02684292), a phase 3, 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. Read more