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.