Array receives approval for BEACON CRC Phase 3 trial

Array BioPharma and the U.S. Food and Drug Administration have reached an agreement regarding Special Protocol Assessment (SPA) for Array’s Phase 3 trial for encorafenib and Erbitux called BEACON CRC.
"Colorectal cancer is the third-most common cancer among men and women in the United States and BRAF-mutant CRC represents a high unmet medical need, as there are currently no targeted treatment options available for patients with this form of the disease,"  Scott Kopetz, University of Texas MD Anderson Cancer Center in Houston and BEACON CRC investigator, said. "The SPA agreement between Array and the FDA represents a welcome next step for the CRC community and, as a physician, I look forward to exploring these novel treatment combinations."
The SPA addresses the design and planned analysis of the BEACON CRC trial and provides assurance that the study met the essential goals that will support a regulatory submission that will lead to the approval of a doublet regimen of encorafenib and Erbitux.
The FDA has also stated that evidence from the study shows that the triplet regimen met its main goal and established a clinical benefit compared to the doublet regimen.