Indication and Limitations of Use

Vectibix® is indicated for treating adult patients with wild-type RAS metastatic colorectal cancer (cancer that has spread outside the colon and rectum). RAS status is determined by an FDA-approved test. Wild-type RAS is a cancer without mutations in the KRAS and NRAS genes.
Vectibix® can be used:

  • As a first-time treatment given with chemotherapy called FOLFOX (folinic acid, fluorouracil, oxaliplatin)
  • Alone, following disease progression with the following chemotherapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

Vectibix®, when given with FOLFOX or alone, is not to be used to treat patients with tumors that have mutations in the RAS gene (called RAS mutant). Vectibix® is not to be used when the RAS mutation status is unknown. Talk to your doctor about your RAS status.

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Results for Vectibix® From Clinical Trials

The results from clinical trials of Vectibix® reinforce the importance of knowing your RAS status when discussing treatment options with your doctor.

Vectibix® is for treating patients with wild-type RAS metastatic colorectal cancer. Vectibix® is not to be used to treat patients with mutant RAS, or whose RAS status is not known.1

Initial treatment for patients after wild-type RAS colorectal cancer has spread

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PRIME Clinical Study

First clinical trial to establish that Vectibix® works for patients' first treatment after colorectal cancer has spread

See PRIME Data

PRIME Clinical Study

The PRIME clinical trial included 512 patients with wild-type RAS* metastatic colorectal cancer who had never been treated for their cancer before:1,2

  • 259 were given Vectibix® + chemotherapy†
  • 253 were given only chemotherapy†

*Defined as WT in NRAS and KRAS.1

†A type of chemotherapy called FOLFOX.2

Patients treated with Vectibix® + chemotherapy lived 5.6 months longer than those treated with chemotherapy alone1,2,*

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*Survival events measured in 82% of patients.
†Half of patients treated with Vectibix® + chemotherapy alive at 25.8 months or longer.
‡Half of patients treated with chemotherapy alone alive at 20.2 months or longer.

Patients treated with Vectibix® + chemotherapy went 2.2 months longer without having their cancer begin to grow again than those treated with chemotherapy alone2

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More patients saw their tumors shrink by at least 30% with Vectibix®1

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The PRIME clinical trial showed the benefits of adding Vectibix® to chemotherapy for people newly diagnosed with wild-type RAS* metastatic colorectal cancer starting their first treatment regimen.1,2

The investigators found that Vectibix® did not work for patients with mutant RAS. Vectibix® is not to be used to treat patients with mutant RAS, or whose RAS status is not known.1 The results shown here are only the patients with wild-type RAS*.

FOLFOX = fluorouracil, leucovorin, and oxaliplatin; mCRC = metastatic colorectal cancer; PRIME = Panitumumab Randomized Trial in Combination with Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy; WT = wild type.

*Defined as WT in NRAS and KRAS.1

Treatment guidelines for oncologists recommend that patients with left-sided WT RAS metastatic colorectal cancer receive a treatment like Vectibix®.5,6

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Vectibix® is a treatment option for people with wild-type RAS metastatic colorectal cancer1

Hear from Vectibix® Patients

References: 1. Vectibix® (panitumumab) prescribing information, Amgen. 2. Douillard J-Y, Oliner KS, Siena S, et al. Panitumumab–FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013;369:1023-1034. 3. Douillard J-Y, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: The PRIME study. J Clin Oncol. 2010;28:4697-4705. 4. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: Revised recist guideline (version 1.1). Eur J Cancer. 2009;45:228-247. 5. Systemic therapy for metastatic colorectal cancer (mCRC) algorithm. ASCO Guidelines®. 2022. 6. Morris VK, Kennedy EB, Baxter NN, et al. Treatment of metastatic colorectal cancer: ASCO guideline. J Clin Oncol. 2023;41:678-700.

Important Safety Information:

Vectibix® can cause skin side effects, which may be severe. In a clinical study, nearly all patients (90%) taking Vectibix® experienced skin rash or other skin reactions. Skin reactions included but were not limited to:

  • Acne-like skin rash
  • Itching
  • Redness
  • Skin rash
  • Skin peeling
  • Nail infections at the side of the nail beds of the fingers or toes
  • Dry skin
  • Openings in the skin

Of these patients, 15% had severe skin reactions that involved, for some, pain, disfigurement, ulceration, or loss of outer layers of skin when receiving Vectibix® alone. Some patients who developed severe skin reactions also developed infections in the blood, skin, fat, or tissue that sometimes resulted in death.

Your doctor may need to make changes to your dose to address your side effects or, in the event of severe or life-threatening side effects, stop Vectibix® treatment. It is important that you tell your doctor right away if you have any skin reactions or any signs of infection (such as chills, fever, or increased redness or swelling of an existing skin reaction).

Patients who have metastatic colorectal cancer with RAS-mutant tumors should not receive Vectibix® with FOLFOX or alone. Several clinical trials have been done evaluating treatments that block part of the pathway that increases tumor cell growth (anti-epidermal growth factor receptor [EGFR]). Anti-EGFR treatments include Vectibix® and Erbitux (cetuximab). In studies of these medicines, patients with RAS-mutant tumors experienced serious side effects without any benefit from the treatment. In one study, patients with RAS-mutant tumors who received Vectibix® + FOLFOX did not live as long as patients who received FOLFOX alone.

Some patients who were taking Vectibix® developed low levels of certain electrolytes, including magnesium, calcium and potassium. Some patients also developed high levels of potassium. Your doctor may check the levels of these electrolytes in your blood while you are on treatment and for up to 2 months after you finish treatment. Your doctor may add other oral or intravenous medications to your Vectibix® treatment.

Vectibix® is given by infusion into a vein. Some patients may develop an infusion reaction, which can be severe and in rare cases has resulted in death. In one clinical study, infusion reactions developed in 4% of patients, and 1% of patients experienced serious infusion reactions. Infusion reactions included:

  • Fever
  • Chills
  • Shortness of breath
  • Throat spasms
  • Low blood pressure

Depending on how severe the reaction is, your doctor may decide to slow the rate of the infusion, stop the infusion, or stop your Vectibix® treatment completely.

Tell your doctor right away if you experience severe diarrhea or dehydration. Some patients treated with Vectibix® and chemotherapy developed kidney failure and other complications because of severe diarrhea and dehydration.

Lung disease, including fatal lung disease, occurred in 1% or less of patients who had taken Vectibix®. Tell your doctor if you have problems breathing, wheezing, or a cough that doesn't go away or keeps coming back. If you have had lung problems in the past, be sure to tell your doctor. Your doctor may decide to stop Vectibix® treatment.

Being in the sun may make skin reactions worse. Wear sunscreen and protective clothing (such as a hat) and avoid direct sunlight while you are on treatment with Vectibix®. Tell your doctor if you have new or worsening skin reactions.

Inflammation of the eye and injury to the cornea have been reported. Tell your doctor if you have any vision changes or eye problems. If you experience any of these side effects or they worsen, your doctor should interrupt or discontinue Vectibix®.

In a study of patients treated for mCRC, the addition of Vectibix® to the combination of Avastin (bevacizumab) and chemotherapy caused patients to experience severe side effects and to not live as long as patients receiving only Avastin and chemotherapy. Do not take Avastin with Vectibix®.

  • Some moderate to severe side effects happened at a higher rate for Vectibix® patients, including acne-like rash, diarrhea, dehydration, painful ulcers and mouth sores, and abnormally low levels of potassium and magnesium in the blood.
  • Serious or potentially fatal blood clots that traveled to the lungs occurred more in Vectibix®-treated patients, and less than 1% of Vectibix®-treated patients died.
  • Because of the side effects experienced, patients receiving Vectibix®, Avastin, and chemotherapy received less chemotherapy for the first 24 weeks of the study compared with those receiving Avastin and chemotherapy.

Vectibix® can cause harm to an unborn child. Use effective birth control to avoid pregnancy while taking Vectibix® and for at least 2 months after the last dose.

In patients who received Vectibix® alone, the most commonly reported side effects (experienced by 20% or more of patients) were different types of skin rash, infections at the side of the nail beds of the fingers or toes, fatigue (extreme tiredness), nausea, and diarrhea.

In patients who received Vectibix® + FOLFOX, the most commonly reported side effects (experienced by 20% or more of patients) were diarrhea, sore mouth, inflammation of mucous membranes, weakness, infection of the nail beds, loss of appetite, low magnesium, low potassium, rash, acne-like skin rash, itching, and dry skin. Serious side effects were diarrhea and dehydration.

These are not all the possible side effects of Vectibix®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read the full Prescribing Information and discuss it with your doctor.

Important Safety Information:

Vectibix® can cause skin side effects, which may be severe. In a clinical study, nearly all patients (90%) taking Vectibix® experienced skin rash or other skin reactions. Skin reactions included but were not limited to:

  • Acne-like skin rash
  • Itching
  • Redness
  • Skin rash
  • Skin peeling
  • Nail infections at the side of the nail beds of the fingers or toes
  • Dry skin
  • Openings in the skin

Of these patients, 15% had severe skin reactions that involved, for some, pain, disfigurement, ulceration, or loss of outer layers of skin when receiving Vectibix® alone. Some patients who developed severe skin reactions also developed infections in the blood, skin, fat, or tissue that sometimes resulted in death.

Your doctor may need to make changes to your dose to address your side effects or, in the event of severe or life-threatening side effects, stop Vectibix® treatment. It is important that you tell your doctor right away if you have any skin reactions or any signs of infection (such as chills, fever, or increased redness or swelling of an existing skin reaction).

Patients who have metastatic colorectal cancer with RAS-mutant tumors should not receive Vectibix® with FOLFOX or alone. Several clinical trials have been done evaluating treatments that block part of the pathway that increases tumor cell growth (anti-epidermal growth factor receptor [EGFR]). Anti-EGFR treatments include Vectibix® and Erbitux (cetuximab). In studies of these medicines, patients with RAS-mutant tumors experienced serious side effects without any benefit from the treatment. In one study, patients with RAS-mutant tumors who received Vectibix® + FOLFOX did not live as long as patients who received FOLFOX alone.

Some patients who were taking Vectibix® developed low levels of certain electrolytes, including magnesium, calcium and potassium. Some patients also developed high levels of potassium. Your doctor may check the levels of these electrolytes in your blood while you are on treatment and for up to 2 months after you finish treatment. Your doctor may add other oral or intravenous medications to your Vectibix® treatment.

Vectibix® is given by infusion into a vein. Some patients may develop an infusion reaction, which can be severe and in rare cases has resulted in death. In one clinical study, infusion reactions developed in 4% of patients, and 1% of patients experienced serious infusion reactions. Infusion reactions included:

  • Fever
  • Chills
  • Shortness of breath
  • Throat spasms
  • Low blood pressure

Depending on how severe the reaction is, your doctor may decide to slow the rate of the infusion, stop the infusion, or stop your Vectibix® treatment completely.

Tell your doctor right away if you experience severe diarrhea or dehydration. Some patients treated with Vectibix® and chemotherapy developed kidney failure and other complications because of severe diarrhea and dehydration.

Lung disease, including fatal lung disease, occurred in 1% or less of patients who had taken Vectibix®. Tell your doctor if you have problems breathing, wheezing, or a cough that doesn't go away or keeps coming back. If you have had lung problems in the past, be sure to tell your doctor. Your doctor may decide to stop Vectibix® treatment.

Being in the sun may make skin reactions worse. Wear sunscreen and protective clothing (such as a hat) and avoid direct sunlight while you are on treatment with Vectibix®. Tell your doctor if you have new or worsening skin reactions.

Inflammation of the eye and injury to the cornea have been reported. Tell your doctor if you have any vision changes or eye problems. If you experience any of these side effects or they worsen, your doctor should interrupt or discontinue Vectibix®.

In a study of patients treated for mCRC, the addition of Vectibix® to the combination of Avastin (bevacizumab) and chemotherapy caused patients to experience severe side effects and to not live as long as patients receiving only Avastin and chemotherapy. Do not take Avastin with Vectibix®.

  • Some moderate to severe side effects happened at a higher rate for Vectibix® patients, including acne-like rash, diarrhea, dehydration, painful ulcers and mouth sores, and abnormally low levels of potassium and magnesium in the blood.
  • Serious or potentially fatal blood clots that traveled to the lungs occurred more in Vectibix®-treated patients, and less than 1% of Vectibix®-treated patients died.
  • Because of the side effects experienced, patients receiving Vectibix®, Avastin, and chemotherapy received less chemotherapy for the first 24 weeks of the study compared with those receiving Avastin and chemotherapy.

 

Vectibix® can cause harm to an unborn child. Use effective birth control to avoid pregnancy while taking Vectibix® and for at least 2 months after the last dose.

In patients who received Vectibix® alone, the most commonly reported side effects (experienced by 20% or more of patients) were different types of skin rash, infections at the side of the nail beds of the fingers or toes, fatigue (extreme tiredness), nausea, and diarrhea.

In patients who received Vectibix® + FOLFOX, the most commonly reported side effects (experienced by 20% or more of patients) were diarrhea, sore mouth, inflammation of mucous membranes, weakness, infection of the nail beds, loss of appetite, low magnesium, low potassium, rash, acne-like skin rash, itching, and dry skin. Serious side effects were diarrhea and dehydration.

These are not all the possible side effects of Vectibix®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read the full Prescribing Information and discuss it with your doctor.

 

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