Roche is seeking approvals for vemurafenib, which the firm says is "the first personalised investigational medicine to have shown a significant overall survival benefit in metastatic melanoma".
Specifically, Roche has filed vemurafenib with the US Food and Drug Administration and the European Medicines Agency for approval for people with BRAF V600 mutation-positive metastatic melanoma. It has also submitted an application for the approval for a companion diagnostic.
Vemurafenib, which has been developed with USA's Plexxikon (which was acquired last month by Daiichi Sankyo) inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer. The submissions are based on two successful studies.
In BRIM3, a 675-patient Phase III trial, participants who received vemurafenib lived longer and also experienced better rates of progression-free survival compared to those who received dacarbazine chemotherapy, Full data will be presented at the American Society of Clinical Oncology meeting in Chicago next month.
The BRIM2 132-patient Phase II study showed that vemurafenib shrank tumours in 52% of trial participants. Patients lived a median of 6.2 months without their disease getting worse.
Hal Barron, Roche's chief medical officer, said that "we have worked swiftly to advance the vemurafenib development programme knowing that patients with metastatic melanoma have a poor prognosis and limited treatment options”. He added 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 personalised therapy for this disease".
Analysts believe that the path to approval should be fairly straightforward, given the unmet medical need and the strong efficacy data Roche has submitted.