NDA Submitted for Vemurafenib for Melanoma
Co-development partners Plexxikon and Genentech have submitted a New Drug Application (NDA) for vemurafenib to treat BRAF V600 mutation-positive metastatic melanoma. Additionally, a premarketing application has been submitted for approval for a companion diagnostic test, cobas 4800 BRAF V600 Mutation Test, which determines whether a patient's tumor tests positive for the BRAF mutation and is eligible to receive vemurafenib treatment. The submissions are based on results from two positive Phase 2 and Phase 3 studies (BRIM2 and BRIM3) that evaluated vemurafenib in patients with BRAF V600 mutation-positive metastatic melanoma, as determined by the investigational companion diagnostic test.
Vemurafenib is an investigational, oral, small molecule that is designed to selectively inhibit a cancer-driving mutated form of the BRAF protein. Vemurafenib is being co-developed under a 2006 license and collaboration agreement between Roche/Genentech and Plexxikon.