FDA's traditional approval of encorafenib followed earlier accelerated approval in same indication

A second FDA record reviewed for this report clarifies the regulatory history behind encorafenib's approval for metastatic colorectal cancer. The agency's listing shows that the FDA granted accelerated approval to encorafenib, marketed as Braftovi by Array BioPharma Inc., a subsidiary of Pfizer Inc., in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer carrying a BRAF V600E mutation, as detected by an FDA-approved test.¹

This accelerated approval preceded the traditional approval reported earlier, which the FDA's listing confirms was granted for the same BRAF V600E-mutant metastatic colorectal cancer indication. The sequencing question flagged in the prior report is now resolved: the accelerated approval came first, with traditional approval following.

The FDA records reviewed do not specify the dates of either approval action, the clinical trial data supporting the accelerated or traditional approval decisions, or whether the traditional approval carried the same combination therapy requirement (cetuximab and mFOLFOX6) as the accelerated approval. No efficacy endpoints, response rates, or survival data are included in either listing.

No company statements from Array BioPharma or Pfizer accompanying either approval action were included in the FDA records reviewed for this report. Further details on the clinical basis for the conversion from accelerated to traditional approval, including confirmatory trial results, would require review of additional FDA or company materials not available in the current source documents.