Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized panitumumab in combination with FOLFIRI for the second-line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRPC) who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). Panitumumab's product information further states that evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with panitumumab and that mutational status should be deteremined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) variants.

This is written in the approval document as:

Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

Citation

Amgen Europe B.V. Vectibix (panitumumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf. Revised July 2022. Accessed March 28, 2024.

Therapeutic response

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

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