According to a Pharmalive report, the European Commission has approved vemurafenib (Zelboraf™) as a first-in-class treatment, for adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

The approval is based on the phase III BRIM3 trial which compared vemurafenib to the standard first-line treatment dacarbazine and demonstrated an improvement in progression-free survival by about 4 months (5.3 months vemurafenib vs. 1.6 months dacarbazine) and overall survival by about 3 months (13.2 months vemurafenib vs. 9.9 months dacarbazine) in 675 untreated patients who tested positive for BRAF V600 mutations. The most common grade 3 or higher adverse events seen more often in people receiving vemurafenib was cutaneous squamous cell carcinoma, keratoacanthomas, rash, liver function abnormalities, joint pain and photosensitivity.

Vemurafenib has also recently been approved in the US, Switzerland, Brazil, Israel, Canada and New Zealand and marketing authorization submissions are currently under review by health authorities in Australia, India and other countries worldwide.