FDA Expands Lilly's Erbitux Label For Colorectal Cancer Setting
- The FDA has approved Eli Lilly And Co's (NYSE: LLY) new indication for Erbitux (cetuximab injection) combined with Pfizer Inc's (NYSE: PFE) Braftovi (encorafenib) for metastatic colorectal cancer.
- The approval covers a new indication of CRC with a BRAF V600E mutation after prior therapy.
- Erbitux is the first, and only anti-EGFR antibody approved, combined with encorafenib, for this indication.
- The approval is based on 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.
- Based on the BEACON CRC trial results, Erbitux plus encorafenib showed a median overall survival of 8.4 months, compared to 5.4 months for the control arm.
- Additionally, Erbitux combo therapy showed an objective response rate of 20%, compared to 2% for the control arm.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: LLY shares are up 2.28% at $226.65 during the premarket session on the last check Wednesday.
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