August 17, 2011
Zelboraf and Companion Diagnostic Test Approved for Metastatic Skin Cancer
The approvals of Zelboraf and the cobas 4800 BRAF V600 Mutation Test were based on data from BRIM3, a Phase 3, international, randomized, open-label, controlled, multicenter trial of 675 patients with late-stage melanoma with the BRAF V600E mutation who had not received prior therapy. Patients were assigned to receive either Zelboraf or dacarbazine. The trial was designed to measure overall survival. The median survival of patients receiving Zelboraf has not been reached (77% still living) while the median survival for those who received dacarbazine was 8 months (64% still living).
Zelboraf, an oral, small molecule, kinase inhibitor, will be available in a 240mg dosage strength tablet.
For more information call (800) 821-8590 or visit www.zelboraf.com.