Pembrolizumab receives FDA approval for extended indications in classical Hodgkin lymphoma

On October 15, 2020, the U.S. Food and Drug Administration (FDA) announced the approval of pembrolizumab as a monotherapy for the treatment of relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). The extended indication of pembrolizumab includes adult patients with R/R cHL following frontline therapy and pediatric patients with refractory cHL or relapsed disease following ≥ 2 lines of therapy.

The decision was based on the randomized phase III KEYNOTE-204 trial (NCT02684292), which resulted in the priority review of second-line pembrolizumab for the treatment of R/R cHL by the FDA in July 2020.  The KEYNOTE-204 trial compared pembrolizumab with standard-of-care brentuximab vedotin in patients with R/R cHL.