FDA approves new indication for Amgen’s Vectibix

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FDA approves new indication for Amgen’s Vectibix

By David Salazar - 06/30/2017

SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Amgen’s Vectibix (panitumumab). The biologic has been approved to treat patients with wild-type RAS metastatic colorectal cancer, the company announced Thursday.


The drug is now indicated as a first-line treatment for the disease, in combination with Folfox or as a monotherapy following the disease’s progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Along with the new indication, the FDA approved a next-generation sequencing-based test to identify the RAS mutation status of a patient’s tumor. The technique allows for a more personalized treatment approach, Amgen said, noting that it helps identify patients who would benefit from treatment with Vectibix.


“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,” Amgen EVP research and development Dr. Sean Harper said. “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.”