GlaxoSmithKline’s Tafinlar Receives EU Approval

GlaxoSmithKline’s (GSK) Tafinlar has been given the green light by the European Commission to be used as an oral treatment for unresectable or metastatic melanoma in adults with a BRAF V600 mutation.

Tafinlar (dabrafenib) is an orally bioavailable inhibitor of BRAF,  part of the pathway that regulates the normal growth and death of cells.  Mutations in BRAF are present in roughly half of the patients who are diagnosed with advanced melanoma.

European approval comes roughly three months after the US regulatory body, the Food and Drug Administration (FDA), approved Tafinlar and another GSK melanoma treatment, the MEK inhibitor Mekinist (trametinib).

Prior to 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.

The European regulatory approval was based partly on results from the phase III BREAK-3 clinical study, which tested Tafinlar against dacarbazine in 250 previously-untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma, in addition to supporting data from phase II clinical studies.

Paolo Paoletti, head of GSK Oncology, commented that GSK have brought Tafinlar to market “in less than five years after our initial testing.”  He noted 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.”


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