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NICE recommends Pierre Fabre's Braftovi in BRAF V600-mutated advanced melanoma

Published on 21/01/19 at 10:16am
Image Credit: Pierre Fabre

Braftovi (encorafenib), a BRAF kinase inhibitor developed by Pierre Fabre, has been awarded approval in combination with Mektovi (binimetinib) by UK drug watchdog NICE for the treatment of unresectable or metastatic melanoma in adult patients with a BRAF V600 mutation, it has emerged.

The decision was determined with the support of Phase 3 data which showed that Braftovi 450mg in combination with twice-daily Mektovi 45mg improved median progression-free survival (PFS) by 14.9 months compared to just 7.3 months for vemurafenib alone, and means that the therapy will now be available on the NHS to eligible patients in England and Wales.

The combo also scored a median overall survival of 33.6 months, compared to 16.9 months with vemurafenib as a monotherapy.

In the UK, there were approximately 15,000 new cases of melanoma diagnosed between the years 2013 and 2015, at whcih time it was the fifth most common cancer in the country.

“This is great news for the melanoma patient community,” commented Gillian Nuttall, CEO of Melanoma UK. “Patients with BRAF-mutant melanoma still face significant challenges managing their disease and there remains a substantial need for well-tolerated treatments that delay disease progression and improve overall survival.”

Paul Lorigan, Professor of Medical Oncology at the University of Manchester and Honorary Consultant Medical Oncologist at the Christie NHS Foundation Trust, added: “Today’s decision to reimburse encorafenib in combination with binimetinib for adults with metastatic BRAF-mutant melanoma is great news for both patients and clinicians, and is a decision that reflects the benefits of this targeted oral combination as shown in the Phase 3 COLUMBUS trial. The availability on the NHS of a therapy ensures that this patient population will soon be able to benefit from an additional treatment option.”

Matt Fellows

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