FDA Extends Approval of Pembrolizumab for Classical Hodgkin Lymphoma
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.