FDA New Drug and Biologic Approvals, 2018 Midyear Review

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).

Reference:

• 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

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.