publication date: Jun. 30, 2017

Drugs and Targets

FDA approves Vectibix for use in wild-type ras metastatic colorectal cancer

FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.

Vectibix is the first-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.

As part of this indication, FDA approved the first multigene, next-generation sequencing-based test to identify the RAS mutation status of a patient’s tumor.

Next-generation sequencing is a novel diagnostics test technique that makes a more personalized medicine approach possible. This companion diagnostic helps physicians identify patients that are more likely to benefit from treatment with Vectibix.

“Of the few biomarkers in colorectal cancer, RAS mutation status provides actionable information when deciding on a first-line treatment option in mCRC patients,” said Marwan Fakih, co-director of the Gastrointestinal Cancer Program at City of Hope, Duarte, Calif.

“Panitumumab has demonstrated a significant overall survival benefit to patients whose mCRC does not have mutations in RAS,” Fakih added, “providing physicians with a novel targeted treatment option and allowing us to develop a personalized approach as we help patients fight this devastating disease.”

The full approval for Vectibix as a treatment for patients with wild-type KRAS mCRC was based on results from the phase III Prime and Aspecct trials. The approval of a refined indication for the treatment of patients with wild-type RAS mCRC was based on a retrospective analysis … Continue reading FDA approves Vectibix for use in wild-type ras metastatic colorectal cancer

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