FDA has approved a new indication for Lilly‘s (NYSE:LLY) Erbitux (cetuximab injection) in combination with Pfizer’s Braftovi (encorafenib) to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation confirmed with an FDA-approved test.

The indication covers previously-treated patients.

Erbitux is currently the only FDA-approved antibody that targets the epidermal growth factor receptor (EGFR). Merck (NYSE:MRK) was also involved in developing the drug.

The recent label expansion is based on data from Pfizer’s Phase 3 BEACON CRC study, which focused on patients with metastatic colorectal cancer with a BRAF V600E mutation.

The latest approval gives Erbitux a total of seven indications covering various colorectal and head-and-neck cancers.

“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,” said Dr. David Hyman, chief medical officer, oncology at Lilly, in a statement.

Volunteers in the trial who received cetuximab and encorafenib had a median overall survival of 8.4 months compared to 5.4 months for control-arm participants.

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Filed Under: Oncology
Tagged With: BRAF V600E, Braftovi, cancer, cetuximab, EGFR, epidermal growth factor receptor, Erbitux, Lilly, Merck
 

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