Roche and Daiichi Sankyo are celebrating this morning after regulators in Europe gave the green light to their personalised cancer drug Zelboraf.
The European Commission has approved Zelboraf (vemurafenib) as a monotherapy for melanoma patients whose tumours express a gene mutation called BRAF V600E. The drug was approved in the USA in August, as was a companion diagnostic co-developed by Roche to detect the BRAF V600E mutation and that test is available in Europe.
The approval is supported by Phase III data which showed the risk of death was reduced by 63% for people who received Zelboraf compared to those on standard first-line treatment. In a post-hoc review of data with a longer follow-up compared to previous analyses, the twice-daily pill showed a median overall survival of 13.2 months compared to 9.6 months for chemotherapy.
Zelboraf "significantly improves patient survival", noted Roche's chief medical officer Hal Barron, who added that the approval "exemplifies the benefits that [the company's] personalised approach to medicine can provide".
As well as the USA and the EU, Zelboraf has also recently been approved in Switzerland, Brazil, Israel, Canada and New Zealand. Marketing authorisation submissions are currently under review in Australia, India and other countries.