Erbitux

Erbitux (cetuximab) is an approved drug with an objective response rate (ORR) of 13% and a median duration of response (DoR) of 5.8 months. In studies, the median progression-free survival (PFS) for cetuximab with FOLFIRI was 8.9 months, compared to 8.1 months for FOLFIRI alone, with a PFS hazard ratio of 0.85 (p-value 0.036). For K-Ras Wild-type patients, the ORR with FOLFIRI was 39%, and the median PFS for cetuximab with FOLFIRI was 9.5 months versus 8.1 months for FOLFIRI alone, with a PFS hazard ratio of 0.70.

Notable safety findings include an incidence of grade 3 or 4 adverse events ranging from 71.2% to 85.8%, and serious adverse events ranging from 38.9% to 46.1%. Discontinuations due to adverse events occurred in 6.9% to 17.0% of patients, and adverse events leading to death were observed in 4.3% to 4.4% of cases. Infusion reactions (any grade) were reported in 8.4% of patients, with severe (Grades 3 and 4) reactions in 2.2%. Erbitux received FDA approval on April 6, 2021, under application number 125084, with a proposed dosing schedule of 500 mg/m2 every two weeks. Pediatric study requirements were waived or exempted.