FDA has approved revisions to the US prescribing information for Amgen’s epidermal growth factor receptor (EGFr) class of antibodies, including Vectibix (panitumumab).
The decision follows the FDA’s December 2008 Oncologics Drugs Advisory Committee (ODAC) meeting, where the clinical utility of the Kras gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-EGFr antibody, was discussed.
This label update is specific to the utility of Kras as a biomarker for Vectibix used as a monotherapy. In the combination chemotherapy setting, the Vectibix 181 and Prime (203) trials will be the first prospective studies testing the clinical utility of Kras as a predictive biomarker in mCRC patients in earlier lines of therapy.
Sean Harper, CMO and head of Global Development at Amgen, said: We are pleased that the FDA has recognized the clinical importance of Kras as a predictive biomarker for anti-EGFr antibody therapy.
With this label update, physicians can now eliminate anti-EGFr antibodies as a treatment option for patients with mutated Kras tumors and redirect those patients to alternative therapies, avoiding unnecessary treatments in patients who are unlikely to benefit, he added.