VECTIBIX
Vectibix (panitumumab) is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC). For patients with wild-type RAS (KRAS and NRAS) status, it is used as a first-line therapy in combination with FOLFOX or as a monotherapy following progression on standard chemotherapy. It is also indicated in combination with sotorasib for patients with KRAS G12C-mutated mCRC who have received prior chemotherapy. Treatment is restricted to patients with confirmed RAS status as determined by an FDA-approved test.
How VECTIBIX Works
Panitumumab binds specifically to the epidermal growth factor receptor (EGFR), a protein overexpressed in colorectal cancers that regulates cellular growth and survival. By competitively inhibiting the binding of natural ligands, the drug prevents receptor activation and the signaling of intracellular proteins involved in tumor proliferation. In the context of KRAS G12C-mutated cancer, EGFR activation serves as a resistance mechanism, and panitumumab works with sotorasib to increase antitumor activity. This process leads to inhibited cell growth, induction of apoptosis, and decreased production of vascular growth factors.
Details
- Status
- Prescription
- First Approved
- 2006-09-27
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
VECTIBIX Approval History
What VECTIBIX Treats
1 indicationsVECTIBIX is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Colorectal Cancer
VECTIBIX Boxed Warning
DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: DERMATOLOGIC TOXICITY See full prescribing information for complete boxed warning . Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving monotherapy...
WARNING: DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: DERMATOLOGIC TOXICITY See full prescribing information for complete boxed warning . Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving monotherapy. ( 2.3 , 5.1 , 6.1 )
VECTIBIX Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
VECTIBIX Competitors
Pro10 other drugs also target HER2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (HER2). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VECTIBIX FDA Label Details
ProIndications & Usage
FDA Label (PDF)Vectibix is an epidermal growth factor receptor (EGFR) antagonist 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,...
WARNING: DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.