EMA recommends approval of Roche's Zelboraf

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorization for Swiss drug major Roche’s (ROG: SIX) Zelboraf (vemurafenib), a novel protein-kinase inhibitor to treat patients suffering from metastatic or unresectable melanoma with BRAF V600 mutations, the deadliest form of skin cancer.

The CHMP’s recommendation is now being sent to the European Commission for the adoption of a binding decision and a final decision is expected in February 2012, said Roche. Zelboraf - along with a companion diagnostic - was approved by the US Food and Drug Administration in the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma this summer (The Pharma Letter August 18). Zelboraf was originated by the USSA’s Plexxikon, which was acquired by Japanese drug major Daiichi Sankyo (TYO: 4568).

There is a high unmet medical need for alternative treatments for metastatic melanoma that improve survival of patients. In the pivotal clinical trial, Zelboraf (vemurafenib), the new protein-kinase inhibitor, was compared to the standard first-line treatment of dacarbazine. The medicine was shown to improve progression-free survival (PFS) by about four months (5.3 months for vemurafenib compared to 1.6 months for dacarbazine) and overall survival (OS) by about three months (13.2 months for vemurafenib compared to 9.9 months for dacarbazine) in patients who tested positive for BRAF V600 mutations.