First personalised drug Zelboraf is approved in EU
Basel/Berkeley – Europe enters into the age of personalised medicine. The European Commission has approved the melanoma drug Zelboraf. While the compound was developed by US-based Plexxikon Inc., owned by Daiichi Sankyo Group, the companion diagnostic is made by Roche. Zelboraf is a selective oral blocker of the oncogenic V600E mutant BRAF kinase RO5185426 in patients with metastatic melanoma. About half of patients carry the mutation. “We are very pleased that our strategy to co-develop Zelboraf along with a companion diagnostic helped accelerate the availability of this personalised medicine for these patients”, said Plexxikon'S CEO Peter Hirth. Roche claims that the companion diagnostic significantly reduced development and approval time of the treatment. The cobas 4800 BRAF V600 test is already commercially available in Europe. Roche Molecular Diagnostics developed the test following a 2005 agreement with Plexxikon. It is the first companion diagnostic designed simultaneously with the drug from scratch. The package has already been approved in the US, Switzerland, Israel, Brazil, New Zealand and Canada. In contrast to existing treatments with interleukin 2 or the chemotherapeutic agent dacarbazine, to which 10-20% of melanoma patients respond, targeted treatment with Zelboraf showed a response rate in more than 80% of patients. After a year of treatment, 55% of patients who received Zelboraf were alive, according to results from the Phase III study, as compared to 43% of patients who received chemotherapy.