FDA expands Erbutix label with Braftovi for BRAF V600E mutation-positive metastatic colorectal cancer after prior therapy.

Erbutix 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 III trial to specifically study patients with previously treated metastatic CRC with a BRAF V600E mutation. With this approval, Erbutix 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 Erbutix 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, Erbutix 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 Erbutix or FOLFIRI with Erbutix) ([HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]). Additionally, Erbutix 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, 1r7) ([hr 0.40, (95% ci: 0.31, 0.52), p><0.0001]).></0.0001]).></0.0001),>

The safety of Erbutix (400 mg/m2 initial infusion, followed by 250 mg/m2 weekly) in combination with encorafenib (300 mg once daily) was evaluated in 216 patients with BRAF V600E mutation-positive metastatic CRC in a randomized, open-label, active-controlled trial (BEACON CRC). The most common ( greater than 25%) adverse reactions in patients receiving Erbutix in combination with encorafenib were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. The labeling for Erbutix includes warnings and precautions for infusion reactions, cardiopulmonary arrest, pulmonary toxicity, dermatologic toxicity, hypomagnesemia and accompanying electrolyte abnormalities, and embryo-fetal toxicity.