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EMA Recommends Extension of Indications for Encorafenib

It is indicated in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation
06 May 2020
Anticancer agents & Biologic therapy;  Gastrointestinal cancers;  Personalised medicine

On 30 April 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product encorafenib (Braftovi).

The marketing authorisation holder for this medicinal product is Pierre Fabre Medicament.

The CHMP adopted a new indication as follows:

Encorafenib is indicated (new text in bold):

  • in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
  • in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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