Amgen announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX, and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. The approval marks Vectibix as the first fully human monoclonal anti-epidermal growth factor receptor (EGFR) antibody approved for this indication.
In addition, the FDA has also approved a multigene, next-generation sequencing-based test to identify RAS mutation status of the patient’s tumor and help physicians identify patients who will more likely benefit from Vectibix.
The approval of Vectibix for wild-type KRAS mCRC was supported by data from the Phase 3 trials, PRIME and ASPECCT; the approval of a refined indication for wild-type RAS mCRC was supported by data from PRIME and ‘0007. The ‘0007 study (n=377) compared the efficacy of Vectibix + best supportive care (BSC) vs. BSC alone in patients with chemorefractory, wild-type KRAS mCRC. Data from a secondary endpoint showed that patients with wild-type RAS (exons 2, 3, and 4 of KRAS and NRAS) mCRC who received Vectibix + BSC had a statistically significant improvement in overall survival (OS) vs. BSC alone (10 months vs. 6.9 months; hazard ratio [HR] 0.70, 95% CI: 0.53, 0.93; P=0.0135).
Patients with wild-type RAS mCRC demonstrated a comparable safety profile compared to what was seen in patients with wild-type KRAS mcRC. The most common side effects with Vectibix monotherapy were skin rash, paronychia, fatigue, nausea, and diarrhea.
Vectibix is now indicated for mCRC patients with wild-type RAS, defined as wild-type in both KRAS and NRAS, as determined-by an FDA-approved test. It is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown. Vectibix is available as 20mg/mL strength solution for IV infusion in 5mL, 10mL, and 20mL single-use vials.
For more information call (800) 772-6436 or visit Vectibix.com.