INDICATION AND LIMITATION OF USE

Vectibix® is indicated 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):Read More

Prescribing Information Indication Important Safety Information Patient Site
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paradigm

THE LEFT SIDE STORY

PARADIGM is the first study designed to test the superiority of panitumumab vs bevacizumab when used with standard chemotherapy, in WT RAS* left-sided mCRC, in Japanese patients.3

A LOOK BACK AT THE PRIME STUDY

The efficacy of Vectibix® as first-line (1L) therapy in WT RAS* patients was first established in PRIME, a phase 3 study. Results showed early targeted therapy with Vectibix® + FOLFOX4 improved median PFS by 27.8% and median OS by 5.6 months vs FOLFOX4 alone.1,2

NOW, LET’S LOOK TO THE LEFT.

Presented at ASCO, June 2022
Published in the Journal of the American
Medical Association, April 2023

*Defined as wild type in both KRAS and NRAS.1 mCRC = metastatic colorectal cancer.

upward moving bar graph

EFFICACY AS 1L THERAPY FIRST ESTABLISHED IN THE PRIME STUDY

5.6-month increase in median OS† with Vectibix® + FOLFOX4 vs FOLFOX4 alone in patients with newly diagnosed WT RAS* mCRC1

EXPLORE PRIME STUDY
Documents for ASCO Guidelines

SELECTING HIGHLY TARGETED 1L TREATMENTS BASED ON RAS STATUS AND TUMOR SIDEDNESS IS CRITICAL FOR IMPROVING PATIENT OUTCOMES3,4

ASCO Guidelines now strongly recommend anti-EGFR therapy plus doublet chemotherapy 1L for patients with WT RAS* left-sided mCRC3

LEARN MORE ABOUT TARGETED TREATMENT
Study population

PROVEN IN CHEMOREFRACTORY PATIENTS

EXPLORE ASPECCT STUDY
EXPLORE 0007 STUDY

VECTIBIX® IS THE #1 PRESCRIBED ANTI-EGFR IN mCRC5,‡

EXPAND YOUR KNOWLEDGE WITH VECTIBIX® VIDEOS AND PODCASTS

Join leading clinical experts as they discuss the studies that have helped inform targeted treatment recommendations for patients with WT RAS mCRC.

Experts discuss studies and recommendation treatments for patients with WT RAS mCRC

FROM PRIME TO PRACTICE

Join Dr. Marwan Fakih as he discusses the importance of moving to more targeted 1L treatment of newly diagnosed WT RAS* mCRC patients.

Dr. Fakih is a paid consultant for Amgen.

Vectibix® (panitumumab) podcast as experts discuss studies and recommendation treatments for patients with WT RAS mCRC

REAL-WORLD IMPLICATIONS FROM THE PRIME STUDY

Hear clinical experts discuss the real-world implications from the PRIME study.

Dr. Philip and Dr. Tauer are paid consultants for Amgen.

EXPLORE MEDIA

*Defined as wild type in both KRAS and NRAS.1

†OS with updated information based on events in 82% of patients.1

‡Based on total patient counts for patients treated for mCRC from IQVIA LAAD claims data from January 2018 through September 2022.5

1L = first-line; ASCO = American Society of Clinical Oncology; ASPECCT = A Study of Panitumumab Efficacy and Safety Compared to Cetuximab; EGFR = epidermal growth factor receptor; FOLFOX = fluorouracil, leucovorin, and oxaliplatin; LAAD = longitudinal access and adjudication data; mCRC = metastatic colorectal cancer; OS = overall survival; PARADIGM = Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC; PFS = progression-free survival; PRIME = Panitumumab Randomized Trial in Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy; WT = wild type.

LEARN WHY TARGETED TREATMENT IS VITAL

Dr. Fakih is a paid consultant for Amgen.

REAL-WORLD TREATMENT IMPLICATIONS
FROM THE PRIME STUDY

Drs. PHILIP AND TAUER

Drs. Philip and Tauer

Real-world treatment implications from the Prime study

IMPORTANT SAFETY INFORMATION

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)].

  • In Study 20020408, dermatologic toxicities occurred in 90% of patients and were severe (NCI0CTC grade 3 and higher) in 15% of patients with mCRC receiving Vectibix®. The clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
  • Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix®. Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix®. 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). Withhold or discontinue Vectibix® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix® concerning dermatologic toxicity are provided in the product labeling.
  • Vectibix® is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS 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.”
  • 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. Additionally, in Study 20050203, 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.
  • Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia occurred in up to 7% (in Study 20080763) of patients across clinical trials. Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix® treatment, periodically during Vectibix® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
  • In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC grades 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
  • Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix® in combination with chemotherapy.
  • Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix®. Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix®. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix® therapy. Discontinue Vectibix® therapy if ILD is confirmed.
  • In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix® versus the risk of pulmonary complications must be carefully considered.
  • Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix®.
  • Serious cases of keratitis, ulcerative keratitis, and corneal perforation have occurred with Vectibix® use. Monitor for evidence of keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix® therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
  • In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC grade 3-4 adverse reactions occurring at a higher rate in Vectibix®-treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs < 1%), and hypomagnesemia (4% vs 0).
  • NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate in Vectibix®-treated patients (7% vs 3%) and included fatal events in three (< 1%) Vectibix®-treated patients. As a result of the toxicities experienced, patients randomized to Vectibix®, bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
  • Vectibix® can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix®.
  • In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
  • The most commonly reported adverse reactions (≥ 20%) with Vectibix® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. The most common serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.

Please see Vectibix® full Prescribing Information, including Boxed WARNING.

INDICATION

Vectibix® is indicated 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):

  • As first-line therapy in combination with FOLFOX.
  • 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.

IMPORTANT SAFETY INFORMATION

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)].

References 1. Vectibix® (panitumumab) prescribing information, Amgen. 2. Douillard J-Y, Oliner KS, Siena S, et al. N Engl J Med. 2013;396:1023-1034. 3. Watanabe J, Muro K, Shitara K, et al. JAMA. 2023;329:1271-1282. 4. Morris VK, Kennedy EB, Baxter NN, et al. J Clin Oncol. 2023;41:678-700. 5. Data on file, Amgen; 2022.

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