FDA Drug Approvals: Oncology and Hematology — Year in Review 2018

Mary L Windle, PharmD


January 15, 2019

New Drugs for Metastatic Melanoma

Braftovi (encorafenib)
Mektovi (binimetinib)

The combination use of encorafenib, a BRAF inhibitor, plus binimetinib, a MEK inhibitor, was approved for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Results from the phase 3 COLUMBUS trial supported the approval. The trial demonstrated that the combination doubled median progression-free survival compared with vemurafenib alone (14.9 months vs 7.3 months, respectively [P <.0001]). (Lancet Oncol. 2018 May;19(5):603-615) Overall median survival was 33.6 months with encorafenib plus binimetinib compared with 16.9 months with vemurafenib (P <.0001). (Lancet Oncol. 2018 Oct;19(10):1315-1327)


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