GlaxoSmithKline’s Tafinlar is on course to become the second BRAF inhibitor to reach the European market after a key regulatory committee recommended it be approved.
Tafinlar (dabrafenib) is under consideration as a treatment for adult patients with advanced (unresectable or metastatic) melanoma expressing a BRAF V600 gene mutation.
Tafinlar, which is given orally, has been shown to delay the progression of the disease and to improve the response rate compared with the chemotherapy dacarbazine.
The positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) lines Tafinlar up to compete with Roche’s Zelboraf (vemurafinib), which won EU approval last year.
Mutations of the protein kinase BRAF have been identified in about half of patients with metastatic melanoma, with the BRAF V600E mutation found in about 80 to 90 per cent of these.
These mutations cause the cell to make an abnormal protein that promotes cancer growth, and it’s this abnormal protein that Tafinlar and Zelboraf seek to block, helping to slow down the growth and spread of tumours.
Such personalised medicines represent a significant therapeutic advance in melanoma treatment, follows decades when treatment options centred around cytotoxic chemo- and immunotherapy.
Melanoma is the sixth most common malignancy in men and the seventh most common in women, with almost 60,000 new cases diagnosed every year in Europe.
Cutaneous melanoma, the most common form of melanoma, is also the most aggressive type of skin cancer, with a median survival time for patients with stage IV melanoma of approximately six months.
Tafinlar won FDA approval in the US in May and now the CHMP recommendation puts the drug on course to receive full European approval by the European Commission within its usual decision timeline of three months.