FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD


August 01, 2018

In This Article

Unresectable or Metastatic Melanoma: Braftovi (encorafenib)

Indication: Indicated in combination with binimetinib for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

Mechanism: Kinase inhibitor that targets BRAF V600E. This pathway regulates several key cellular activities, including proliferation, differentiation, survival, and angiogenesis; inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma.

Dosage: 450 mg PO once daily in combination with binimetinib until disease progression or unacceptable toxicity. Dosage modifications are recommended for toxicities.

Approval was based on results from the phase 3 COLUMBUS trial, which demonstrated that the combination doubled median progression-free survival (mPFS) compared with vemurafenib alone (14.9 months versus 7.3 months, respectively (P<0.0001).


  • Dummer R, Ascierto PA, Gogas HJ, et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2018 May;19(5):603-615. https://www.ncbi.nlm.nih.gov/pubmed/29573941


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.