It has been revealed that Roche has filed regulatory submission for vemurafenib with the US Food and Drug Administration and the European Medicines Agency for approval to be used for people with BRAF V600 mutation-positive metastatic melanoma. Moreover, it has submitted an application for the approval for a companion diagnostic.

Vemurafenib inhibits a mutated form of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive forms of skin cancer. The company has filed the application on the basis of two studies BRIM3 and BRIM2.

In BRIM3 included a 675-patient Phase III trial. During the study, it was found that participants who received vemurafenib lived longer and also experienced better rates of progression-free survival compared to those who received dacarbazine chemotherapy.

In the other study, BRIM2, 132-patient Phase II study was conducted. The study showed that vemurafenib shrank tumors in 52% of trial participants. Patients lived a median of 6.2 months without their disease getting worse.

The Chief Medical Officer of Roche, Hal Barron, said that the company has worked swiftly to advance the vemurafenib development program knowing that patients with metastatic melanoma have a poor prognosis and limited treatment options. He further said that the regulatory submissions of the drug and the companion diagnostic to identify people with the type of melanoma specifically targeted by this medicine "are exciting steps toward our goal of delivering a personalized therapy for this disease".