The predictive biomarker test optimizes the cancer fighter.

The FDA has approved the supplemental Biologics License Application (sBLA) for Vectibix (panitumumab). Along with the approval, Amgen announced physicians will have access to the first multi-gene, next-generation sequencing-based test to identify wild-type RAS mutation status (both KRAS and NRAS) in metastatic colorectal cancer (mCRC) to support more precise diagnosis and treatment.

Amgen described Vectibix as the “first and only fully human monoclonal anti-epidermal growth factor receptor (EGFR) antibody approved by the FDA for this patient population.” The company also said the companion diagnostic will help doctors take a more personalized approach to prescribing chemotherapy, thus realizing the benefits of Vectibix treatment.

Marwan G. Fakih, M.D. Co-Director of the Duarte, California City of Hope Gastrointestinal Cancer Program explained, “of the few biomarkers in colorectal cancer RAS mutation status provides actionable information when deciding on a first-line treatment option in mCRC patients.” Fakih noted the ability to understand RAS mutation status will help boost treatment effectiveness: “Panitumumab has demonstrated a significant overall survival benefit to patients whose mCRC does not have mutations in RAS, providing physicians with a novel targeted treatment option and allowing us to develop a personalized approach as we help patients fight this devastating disease."

According to Amgen, the approval of Vectibix to treat patients with wild-type KRAS mCRC was based on results from its Phase III PRIME and ASPECCT trials. The refined indication to treat wild-type RAS mCRC, said the company, was based on retrospective analysis from the PRIME study and prospective, predefined analysis from the Phase III ‘0007 study. The '0007 study, said Amgen, analyzed the efficacy of Vectibix (including best supportive care (BSC) versus BSC alone in patients with chemorefractory, wild-type KRAS mCRC): “Data from a key secondary endpoint showed that patients with wild-type RAS (exons 2, 3, and 4 of KRAS and NRAS) mCRC treated with Vectibix plus BSC resulted in a statistically significant improvement in overall survival (OS) of 10 months compared to 6.9 months for patients treated with BSC alone (HR=0.70; 95 percent CI: 0.53, 0.93, p=0.0135).”

"This approval for Vectibix reinforces the significance of biomarker testing as a treatment planning tool in metastatic colorectal cancer and further validates the potential for precision medicine to optimize patient outcomes,” said Sean E. Harper, M.D. and Executive VP of Research and Development at Amgen. "Every patient with cancer is unique, and we are committed to utilizing cutting-edge science and technology to target treatments to the patients more likely to benefit."