FDA Expands Lilly's Erbitux Label For Colorectal Cancer Setting

The FDA has approved Eli Lilly And Co's LLY new indication for Erbitux (cetuximab injection) combined with Pfizer Inc's PFE Braftovi (encorafenib) for metastatic colorectal cancer.
The approval covers a new indication of CRC with a BRAF V600E mutation after prior therapy.
Erbitux is the first, and only anti-EGFR antibody approved, combined with encorafenib, for this indication.
The approval is based on Pfizer's BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAF V600E mutation.
With this approval, Erbitux has now received seven FDA approvals to treat certain types of CRC and squamous cell carcinoma of the head and neck.
Based on the BEACON CRC trial results, Erbitux plus encorafenib showed a median overall survival of 8.4 months, compared to 5.4 months for the control arm.
Additionally, Erbitux combo therapy showed an objective response rate of 20%, compared to 2% for the control arm.
Related content: Benzinga's Full FDA Calendar.
Price Action: LLY shares are up 2.28% at $226.65 during the premarket session on the last check Wednesday.