Safety

Vectibix (Panitumumab) Injection for Intravenous Infusion

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

March 2015

Summary View

WARNING AND PRECAUTIONS

Increased Tumor Progression, Increased Mortality, or Lack of Benefit in Patients with RAS-Mutant mCRC
  • Vectibix is not indicated for the treatment of patients with colorectal cancer that harbor somatic mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as “RAS” [see Indications and Usage (1.1), Dosage and Administration (2.1), Clinical Pharmacology (12.1) and Clinical Studies (14)].
  • Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab).
  • Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents [see Indications and Usage (1.1), and Clinical Pharmacology (12.1)].
  • Additionally, in Study 3, 272 patients with RAS-mutant mCRC tumors received Vectibix in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis, OS was shorter (HR = 1.21, 95% CI 1.01-1.45) in patients with RAS-mutant mCRC who received Vectibix and FOLFOX versus FOLFOX alone [see Indications and Usage (1.1)].

 

August 2014

Summary View

WARNINGS AND PRECAUTIONS

Dermatologic and Soft Tissue Toxicity
  • …It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (eg, Stevens Johnson syndrome or toxic epidermal necrolysis)…

ADVERSE REACTIONS

Postmarketing Experience

Skin and subcutaneous tissue disorders:

  • … life threatening and fatal bullous mucocutaneous disease

 

August 2012

Summary View 

WARNINGS AND PRECAUTIONS

Dermatologic Toxicity
  • Monitor patients who develop dermatologic toxicities while receiving Vectibix for the development of inflammatory or infectious sequelae…
 
Increased Mortality or Toxicity with Vectibix in Combination with Chemotherapy 
  • Vectibix is not indicated for use in combination with chemotherapy…       
 
Pulmonary Fibrosis/Interstitial Lung Disease (ILD)
  • Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix. Patients with a history or evidence of interstitial pneumonitis, pulmonary fibrosis, were excluded from most clinical trials…
 

ADVERSE REACTIONS

Immunogenicity
  • As monotherapy: The incidence of binding antibodies (excluding pre-existing and transient positive patients) was 0.4% (3/717), as detected by the acid dissociation ELISA, and 3.8% (27/717) as detected by the Biacore assay… 
  • In combination with irinotecan- or oxaliplatin-based chemotherapy: The incidence of binding antibodies (excluding pre-existing positive patients) was 1% (11/1124) as detected by the acid dissociation ELISA and 0.8% (9/1123) as detected by the Biacore assay…
 

 

Page Last Updated: 04/15/2015
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