Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to panitumumab in combination with FOLFOX for the first-line treatment of 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). The product label specifies a limitation of use that panitumumab is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.

This is written in the approval document as:

Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of 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) in combination with FOLFOX for first-line treatment. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.

Citation

Amgen, Inc. Vectibix (panitumumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf. Revised April 2021. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	Wild type HRAS, Wild type KRAS	Colorectal Adenocarcinoma	Fluorouracil, Oxaliplatin, Panitumumab