29 June 2017 - Approved companion diagnostic tool strengthens precision medicine approach.
Amgen today announced that the U.S. FDA has 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 (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.
Vectibix is the first-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.