Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new indication for ERBITUX (cetuximab injection) in combination with BRAFTOVI (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. 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. 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]). The safety of ERBITUX (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 (=25%) adverse reactions in patients receiving ERBITUX in combination with encorafenib were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. The labeling for ERBITUX includes warnings and precautions for infusion reactions, cardiopulmonary arrest, pulmonary toxicity, dermatologic toxicity, hypomagnesemia and accompanying electrolyte abnormalities, and embryo-fetal toxicity. Please see below for full Important Safety Information. On April 8, 2020, Pfizer's encorafenib was approved by the FDA for this indication, based on data from the BEACON CRC study. Encorafenib in combination with ERBITUX was evaluated in the randomized, active-controlled, open-label, multicenter, Phase 3 BEACON CRC trial. Eligible patients were required to have BRAF V600E mutant metastatic CRC, as detected by an FDA-approved test, with disease progression after one or two prior regimens. Patients were randomized 1:1:1 to one of the following treatment arms: Encorafenib 300 mg orally once daily in combination with ERBITUX (encorafenib/ERBITUX arm). Encorafenib 300 mg orally once daily in combination with ERBITUX and binimetinib. Irinotecan with ERBITUX or FOLFIRI with ERBITUX (control arm). The major efficacy outcome measure was OS. Additional efficacy outcome measures included PFS, ORR, and duration of response (DoR) as assessed by blinded independent central review (BICR). OS and PFS were assessed in all randomized patients. ORR and DoR were assessed in the subset of the first 220 patients included in the randomized portion of the encorafenib/ERBITUX and control arm of the study. A total of 220 patients were randomized to the encorafenib/ERBITUX arm and 221 to the control arm. The trial was conducted at over 200 investigational sites in North America, South America, Europe and the Asia Pacific region. Worldwide, colorectal cancer (CRC) is the second leading cause of cancer death. With approximately 1.9 million new diagnoses in 2020, CRC is third most common type of cancer in men and the second most common in women. In the U.S. alone, an estimated 149,500 people will be diagnosed with cancer of the colon or rectum in 2021, and approximately 53,000 are estimated to die of the disease each year. BRAF mutations are estimated to occur in up to 15% of people with metastatic CRC and represent a poor prognosis for these patients. The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAF V600E mutation is more than two times higher than for those with wild-type BRAF.