Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that Wild type HRAS, Wild type KRAS status confers therapeutic sensitivity to Fluorouracil, Oxaliplatin, Panitumumab in patients with Colorectal Adenocarcinoma.
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 statement is based on a regulatory approval from the Food and Drug Administration:
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.