GSK melanoma therapy Tafinlar cleared in EU

GlaxoSmithKline’s (GSK) melanoma therapy Tafinlar has been cleared in Europe for the skin cancer melanoma, adding to earlier approvals in the US, Canada and Australia.

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.

The landscape for melanoma therapy has changed rapidly in recent years with the approval of Daiichi Sankyo/ Roche’s Zelboraf (vemurafenib) – which also targets BRAF-positive tumours – and Bristol-Myers Squibb’s anti-CTLA4 immunotherapy Yervoy (ipilimumab) in 2011.

Zelboraf had sales of around $180m in the first half of the year, an 84 per cent gain on the same period of 2012, while Yervoy brought in $462m, up 46 per cent, thanks to its broad utility across all melanoma types.

Tafinlar and Mekinist were launched too late into the second quarter to register much in the way of sales but have been predicted by analysts at Cowen & Co to bring in around $350m apiece by 2016.

Others are more optimistic, saying the double-whammy approach of using the drugs in combination could boost collective sales above the $2bn mark at peak. GSK is carrying out a phase III trial comparing Tafinlar and Mekinist to Zelboraf and this should generate results later this year.

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