Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that Wild type HRAS, Wild type KRAS status confers therapeutic sensitivity to Panitumumab in patients with Colorectal Adenocarcinoma.
The U.S. Food and Drug Administration granted approval to panitumumab for the 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)following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. 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) as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.