Priority Review Granted by FDA for Combination Therapy in Metastatic Colorectal Cancer
Posted: Monday, December 23, 2019
On December 18, Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted and granted priority review to the supplemental new drug application for the doublet regimen of encorafenib (Braftovi) plus cetuximab (Erbitux). This review is based on results from the phase III BEACON CRC trial, which evaluated the efficacy and safety of the combination therapy with or without binimetinib (Mektovi) in patients with advanced BRAF V600E–mutant metastatic colorectal cancer after one or two lines of therapy.
As published in The New England Journal of Medicine, the BEACON CRC trial showed improvements in overall survival and objective response rates for both the doublet regimen of encorafenib and cetuximab as well as the triplet regimen of encorafenib, cetuximab, and binimetinic, compared with cetuximab plus irinotecan-containing regimens. In descriptive analyses comparing the doublet and triplet arms, the findings showed comparable efficacy in the overall population with no unexpected toxicities.
If approved, the combination therapy of encorafenib and cetuximab would become the first targeted regimen for patients with BRAF-mutant metastatic colorectal cancer who have received prior treatment. The doublet regimen, with or without binimetinib, is being studied in earlier lines of treatment in this patient population, including the phase II ANCHOR study in previously untreated patients.