Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that Wild type KRAS, Wild type NRAS status confers therapeutic sensitivity to Panitumumab in patients with Colorectal Adenocarcinoma.
The European Medicines Agency (EMA) has authorized panitumumab as a monotherapy for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRPC) after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. 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 statement is based on a regulatory approval from the European Medicines Agency:
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.