Vectibix FDA Approval History
FDA Approved: Yes (First approved September 27, 2006)
Brand name: Vectibix
Generic name: panitumumab
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Colorectal Cancer
Vectibix (panitumumab) is an epidermal growth factor receptor (EGFR) antagonist for use in the treatment of wild-type RAS metastatic colorectal cancer and KRAS G12C-mutated metastatic colorectal cancer.
- Vectibix is indicated for the treatment of:
- adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC)*:
• In combination with FOLFOX for first-line treatment.
• As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
- KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC)*:
• In combination with sotorasib, for the treatment of adult patients with KRAS G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
*Limitations of Use:
Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
Development timeline for Vectibix
Further information
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