Eli Lilly and Co. (LLY) said that the U.S. Food and Drug Administration has granted approval of a new indication for Erbitux or cetuximab injection in combination with Braftovi or encorafenib, marketed by Pfizer, Inc., for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Erbitux is the first and only anti-EGFR antibody approved, in combination with encorafenib, for this indication and is based on results from Pfizer's BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic colorectal cancer with a BRAF V600E mutation.
With this approval, Erbitux has now received seven FDA approvals to treat certain types of colorectal cancer and squamous cell carcinoma of the head and neck.
The BEACON study showed that the combination of Erbitux and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF V600E mutation - a subtype that typically has worse outcomes compared to those without the mutation.
The labeling for Erbitux includes warnings and precautions for infusion reactions, cardiopulmonary arrest, pulmonary toxicity, dermatologic toxicity, hypomagnesemia and accompanying electrolyte abnormalities, and embryo-fetal toxicity.
On April 8, 2020, Pfizer's encorafenib was approved by the FDA for this indication, based on data from the BEACON colorectal cancer study.
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