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Braftovi FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

FDA Approved: Yes (First approved June 27, 2018)
Brand name: Braftovi
Generic name: encorafenib
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Melanoma, Metastatic, Colorectal Cancer

Braftovi (encorafenib) is a kinase inhibitor indicated:

  • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
  • in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Development timeline for Braftovi

Apr  8, 2020Approval FDA Approves Braftovi (encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
Jun 27, 2018Approval Array BioPharma Announces FDA Approval of Braftovi (encorafenib) in Combination with Mektovi (binimetinib) for Unresectable or Metastatic Melanoma with BRAF Mutations

Further information

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