Indication and Limitation of Use

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use: as first-line therapy in combination… read more

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13)… read more

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test… read more

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use: as first-line therapy in combination with FOLFOX, as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

Vectibix® is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.

×
×

You are now leaving Vectibix.com

Please know that the sponsors of this site are not responsible for content on the site you are about to enter.

Cancel
Continue

Biomarker testing and KRAS


Oncology is seeing an increased trend towards personalized medicine1

  • As a part of personalized medicine, biomarkers help inform clinical decisions by distinguishing patients who may or may not benefit from a given treatment1

Biomarker testing can inform first-line treatment planning in mCRC2,3

Download a list of facilities believed to be conducting extended RAS (KRAS, NRAS exons 2-4) testing

  • RAS is a family of oncogenes including the subtypes NRAS and KRAS; KRAS is implicated in cancers such as mCRC2,3
  • The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly recommend that RAS biomarker status be assessed in all patients with mCRC at time of diagnosis in order to determine eligibility for an anti-EGFR therapy4
  • Safety considerations:
    • Patients with RAS-mutant mCRC tumors, or those whose RAS status is unknown, should not be treated with Vectibix®3
    • In Study 3 (PRIME study), 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 alone3

Act on KRAS test results

  • KRAS mutation status provides actionable information when deciding on a first-line treatment option in mCRC3,4

In patients with wild-type (WT) KRAS* mCRC, first-line Vectibix® + FOLFOX improved median OS by 4.4 months vs. FOLFOX alone (exploratory analysis of the PRIME Study)3

  • KRAS mutation status provides actionable information when deciding on a first-line treatment option in mCRC3,4
  • Study 3 (PRIME Study): Phase 3, open-label, randomized, multicenter study of 1,183 previously untreated patients with mCRC who were treated with Vectibix® Q2W + FOLFOX or FOLFOX Q2W alone3,5
  • In WT KRAS patients, Vectibix® + FOLFOX extended the prespecified major efficacy measure of PFS vs FOLFOX alone (9.6 months vs 8.0 months, respectively) [HR = 0.80, 95% CI: 0.66, 0.97; P = 0.02]3
  • In an exploratory analysis of WT KRAS patients, median OS for the Vectibix® + FOLFOX arm (n = 325) was 23.8 months vs 19.4 months for the FOLFOX-alone arm (n = 331) [HR = 0.83, 95% CI: 0.70, 0.98]3
  • No benefit in OS or PFS were observed in patients with RAS-mutant mCRC2,3

Amgen: Committed to advancing personalized medicine

  • As a leader in mCRC research, Amgen is dedicated to advancing patient care with the identification of appropriate biomarkers to aid treatment selection
  • Amgen made the KRAS connection in the PRIME study. In an exploratory analysis, only patients with WT KRAS* mCRC had improved median OS with Vectibix® + FOLFOX vs FOLFOX alone3,5

*Exon 2 in codons 12 or 13.
No benefits in OS or PFS were observed in patients with mutant RAS mCRC.
mCRC = metastatic colorectal cancer; PFS = progression-free survival; OS = overall survival; Q2W = every two weeks.
PRIME = The Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy.

Site Map
×