Tafinlar (Dabrafenib) approvato nell’Unione Europea per la terapia del melanoma metastatico inoperabile

La commissione europea ha approvato l’uso del Tafinlar,Dabrafenib, nella monoterapia del melanoma metastatico inoperabile in pazienti che esprimono il gene BRAF V600E

Leggi: The European Commission (EC) gave a green light to Tafinlar (dabrafenib) as a monotherapy for unresectable or metastatic melanoma in adults who are shown to express the BRAF V600E gene variant on validated testing, said GSK. 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 implicated in around half of patients diagnosed with advanced melanoma. EU approval was based partly on data from the phase III BREAK-3 study that tested Tafinlar against dacarbazine in 250 previously-untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma, as well as supporting data from phase II studies Data unveiled in June 2012 showed that GSK’s drug reduced the relative risk of disease progression or death by 63 per cent compared to dacarbazine and also increased median progression-free survival (PFS) to 6.9 months from 2.7 months. Meanwhile, a post-hoc analysis from December 2012 demonstrated overall survival of 70 per cent with Tafinlar after one year, compared with 63 per cent for dacarbazine. GSK filed for approval of Tafinlar in combination with its MEK inhibitor Mekinist (trametinib) which was also approved for melanoma in the US earlier this year along with a new companion diagnostic developed by bioMerieux to guide the drugs’ use.

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