Privately-held French drugmaker Pierre Fabre today announced that UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Braftovi (encorafenib) plus cetuximab, within its marketing authorization, as an option for treating BRAFV600E mutation-positive metastatic colorectal cancer (mCRC), in adults who have had previous systemic treatment.
Braftovi was approved in the mCRC indication by the European Commission in June this year. The drug was cleared for the treatment of unresectable or metastatic melanoma with a BRAF mutation in 2018.
This positive recommendation addresses the urgent need for effective and well-tolerated treatment options, since the current standard of care for these patients is chemotherapy-based regimens which have shown minimal response rates. Encorafenib plus cetuximab represents the first and only targeted combination regimen licensed in Europe specifically for BRAFV600E mCRC, and is now funded for these patients on the NHS in England, Wales and Northern Ireland, notes Pierre Fabre.
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