Benzinga | Sep 28, 2021 05:50PM EDT

Eli Lilly Says FDA Expands Co's ERBITUX (cetuximab) Label With Combination Of BRAFTOVI (encorafenib) For Treatment Of BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) After Prior Therapy

Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new indication for ERBITUX(r) (cetuximab injection) in combination with BRAFTOVI(r) (encorafenib), marketed by Pfizer, Inc., for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.1 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 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 to those without the mutation," said David Hyman, M.D., chief medical officer, oncology at Lilly. "We are grateful to Pfizer for their collaboration as we've worked to bring this treatment regimen to patients."

Based on results from the BEACON CRC trial, ERBITUX plus encorafenib showed a median overall survival (OS) of 8.4 months (95% CI: 7.5, 11.0), compared to 5.4 months (95% CI: 4.8, 6.6) for the control arm (irinotecan with ERBITUX or FOLFIRI with ERBITUX) ([HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]). Additionally, ERBITUX plus encorafenib showed an objective response rate (ORR) of 20% (95% CI: 13%, 29%), compared to 2% (95% CI: 0%, 7%) for the control arm (p<0.0001), and a median progression-free survival (mPFS) of 4.2 months (95% CI: 3.7, 5.4), compared to 1.5 months for the control arm (95% CI: 1.4, 1.7) ([HR 0.40, (95% CI: 0.31, 0.52), p<0.0001]).