European Commission approves Tafinlar for metastatic melanoma

The European Commission has given marketing authorization for dabrafenib as monotherapy for unresectable or metastatic melanoma in adults with a BRAF V600 mutation, GlaxoSmithKline announced.

Dabrafenib (Tafinlar), a kinase inhibitor that targets BRAF, can be used after a diagnostic test confirms the BRAF V600 mutation in patients with unresectable or metastatic melanoma.

The European Commission’s decision was based on results from several multicenter global trials, according to a GlaxoSmithKline press release. In a phase 3 study, dabrafenib was compared with dacarbazine (chemotherapy) in 250 previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma. Relative risk for disease progression or death was reduced by 70% in dabrafenib-treated patients compared with dacarbazine (95% CI, 0.18-0.51), according to analysis conducted in December 2011. Dabrafenib-treated patients had a median progression-free survival of 5.1 months (95% CI, 4.9-6.9 months) compared with 2.7 months for dacarbazine (95% CI, 1.5-3.2 months).

According to post-hoc analysis 6 months later, dabrafenib reduced relative risk for disease progression or death by 63% compared with dacarbazine (95% CI, 0.24-0.58). Median progression-free survival of patients treated with dabrafenib was 6.9 months (95% CI, 5.2-9 months) compared with 2.7 months for dacarbazine (95% CI, 1.5-3.2 months).

Adverse drug reactions reported with dabrafenib, based on data from five monotherapy studies involving 578 patients with melanoma, included hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, skin papilloma, alopecia, rash and vomiting, according to the release.

“Authorization of Tafinlar represents an important step in GlaxoSmithKline’s ongoing effort to bring new treatment options to cancer patients, especially as we have brought it to market in less than 5 years after our initial testing,” Paolo Paoletti, MD, president of GlaxoSmithKline Oncology, said in the release.

In May, the FDA approved dabrafenib for treating patients with metastatic or unresectable melanoma.