FDA Approves Erbitux/Braftovi Combination for Advanced Colorectal Cancer

This is the seventh approval for Erbitux and the only anti-EGFR antibody approved for this indication.

The FDA has granted approval of a new indication for Lilly’s Erbitux (cetuximab) in combination with Pfizer’s Braftovi (encorafenib) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation.

Erbitux is the first anti-EGFR antibody approved for this indication and is based on results from Pfizer’s BEACON CRC trial, a 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.

“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 with those without the mutation,” David Hyman, M.D., chief medical officer, oncology at Lilly, said in a statement.

The combination of Erbitux and Braftovi showed a median overall survival of 8.4 months compared with 5.4 months for the control arm of Erbitux with either the chemotherapy irinotecan or the chemotherapy regimen known as FOLFIRI.

Additionally, Erbitux/Braftovi showed an objective response rate of 20% compared with 2% for the control arm and a median progression-free survival of 4.2 months compared with 1.5 months for the control arm.

he most common adverse reactions were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash.

In April 2020, the FDA approved Pfizer’s Braftovi for this indication, based on data from the BEACON CRC study.

Colorectal cancer is the fourth most common type of cancer, according to the National Cancer Institute. The NCI estimates that in 2021, there will be almost 150,000 new cases of colorectal cancer and more than 50,000 deaths.