Roche Files Vemurafenib for Regulatory Approval

On May 11, the Swiss drug maker, Roche, announced that is seeking both European and US backing for its drug, vemurafenib, which is used to treat patients with the most aggressive and deadliest form of skin cancer. Another application, also submitted by Roche, was for the cobas 4800 BRAF V600 Mutation Test. This is a companion diagnostic test designed to identify patients who are most likely to benefit from the drug.

Vemurafenib, a BRAF inhibitor, works by selectively targeting and inhibiting a mutated form of the BRAF protein found in about half of all cases of melanoma. Melanoma, the deadliest form of skin cancer, kills about 40,000 people each year worldwide.

Roche submitted the applications for both vemurafenib and the cobas 4800 BRAF V600 mutation assay based on results from 2 successful studies. Roche is aiming to file for the approval of the drug some time in late 2012 and hopes to launch the drug by early 2013. Analysts have estimated sales of vemurafenib around $0.5-$1 billion.

In the BRIM3 and BRIM2 trials, researchers found that vemurafenib helped to extend the period in which the patients’ disease did not get worse (when compared to dacarbazine), and that that the vemurafenib actually shrank tumors in 52% of the patients. Full data from both of these studies will be presented at the 47th Annual American Society of Clinical Oncology meeting in early June.