Plexxikon’s Zelboraf® (vemurafenib) has been approved by the European Commission as a monotherapy for the treatment of adult patients with BRAFV600 mutation-positive unresectable or metastatic melanoma.

FDA-approved Zelboraf is a novel, oral small molecule, which was designed to selectively inhibit the BRAF mutation.

The BRIM3 global randomised open-label controlled multicentre Phase 3 study compared Zelboraf to dacarbazine (chemotherapy), in 675 patients with previously untreated BRAFV600E mutation-positive, unresectable (inoperable) or metastatic melanoma.

The study endpoints included overall survival (OS), investigator-assessed progression-free survival (PFS), and confirmed investigator-assessed overall response rate.

"The approval of Zelboraf by the European Commission marks a significant advancement for European patients with metastatic melanoma who historically have had very limited treatment options," said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon.

"We are very pleased that our strategy to co-develop Zelboraf along with a companion diagnostic helped accelerate the availability of this personalized medicine for these patients."

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The pre-specified interim analysis of BRIM3 reported that patients who received Zelboraf showed 63% reduction in risk of death compared to those who received standard first-line treatment.

The post-hoc analysis of BRIM3 data demonstrated that patients in the Zelboraf treatment arm considerably improved survival by providing a median overall survival of 13.2 months compared to 9.6 months for those who received chemotherapy.

The data also showed that at 12 months, 55% of patients who received Zelboraf were alive, compared to 43% of patients who received chemotherapy.

In the single arm BRIM2 study of previously treated patients, Zelboraf treatment also showed a survival benefit compared to historical control data.

Currently, Zelboraf and its companion diagnostic are approved in the US, Switzerland, Israel, Brazil, New Zealand and Canada.

Plexxikon, a member of Daiichi Sankyo Group, aims to develop novel small molecule pharmaceuticals to treat human disease.