GlaxoSmithKline’s Tafinlar has been approved by the European Commission as an oral treatment for unresectable or metastatic melanoma in adults with a BRAF V600 mutation.
The approval comes some three months after the US Food and Drug Administration gave the green light to Tafinlar (dabrafenib) and another GSK melanoma treatment, the MEK inhibitor Mekinist (trametinib). Before taking dabrafenib, patients must have confirmation of a BRAF V600 mutation using a validated test and GSK has developed a companion diagnostic in conjunction with France’s bioMerieux.
Paolo Paoletti, head of GSK Oncology, noted that the company has brought Tafinlar to market "in less than five years after our initial testing”. He added that “with this new personalised medicine, we hope to make a meaningful difference in the lives of appropriate patients with metastatic melanoma, a devastating disease and a cancer with one of the lowest survival rates".
Tafinlar will now go up against Roche’s Zelboraf (vemurafenib) and Bristol-Myers Squibb’s Yervoy (ipilimumab).