Regulatory approval

Published by the Food and Drug Administration. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	Wild type HRAS, Wild type KRAS	Colorectal Adenocarcinoma	Fluorouracil, Oxaliplatin, Panitumumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2021-08-25	Food and Drug Administration	Indication received traditional approval.