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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.
Merck. FDA approves expanded indication for Merck’s KEYTRUDA® (pembrolizumab) in adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). https://www.merck.com/news/fda-approves-expanded-indication-for-mercks-keytruda-pembrolizumab-in-adult-patients-with-relapsed-or-refractory-classical-hodgkin-lymphoma-chl/. Published Oct 15, 2020. Accessed Oct 16, 2020.
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