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Adcetris

Active Substance: brentuximab vedotin
Common Name: brentuximab vedotin
ATC Code: L01XC12
Marketing Authorisation Holder: Takeda Pharma A/S
Active Substance: brentuximab vedotin
Status: Authorised
Authorisation Date: 2012-10-25
Therapeutic Area: Hodgkin Disease Lymphoma, Non-Hodgkin
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):

  • following autologous stem cell transplant (ASCT) or
  • following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following ASCT.

Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

What is Adcetris and what is it used for?

Adcetris is a cancer medicine used to treat adults with Hodgkin’s lymphoma (HL, a type of cancer that originates from blood cells in the lymphatic system, a part of the immune system) when the tumour cells are CD30-positive (when they have a protein called CD30 on their surface). It is used:

  • when the cancer has come back or has not responded to an autologous stem cell transplant (a transplant of the patient's own blood-producing cells);
  • when patients have had an autologous stem cell transplant but are considered to be at increased risk of the cancer coming back or not responding;
  • when the cancer has come back or has not responded to at least two other therapies and when autologous stem cell transplant or multi-agent chemotherapy (a combination of cancer medicines) cannot be used.

Adcetris is also used to treat adults with two other lymphomas:

  • systemic anaplastic large cell lymphoma (sALCL, a CD30-positive cancer of white blood cells called T lymphocytes), when the cancer has come back or has not responded to other treatments;
  • CD30-positive cutaneous T-cell lymphoma (CTCL), a lymphoma of T lymphocytes that initially affects the skin, in patients who have received at least one previous treatment.

Because the number of patients with these conditions is low, the diseases are considered ‘rare’, and Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) on various dates (see below).

Adcetris contains the active substance brentuximab vedotin.

How is Adcetris used?

Adcetris can only be obtained with a prescription, and it should be given under the supervision of a doctor who has experience in the use of cancer treatments.

The recommended dose is 1.8 mg per kilogram body weight given by a 30-minute infusion (drip) into a vein every three weeks. Patients should be monitored during and after the infusion for certain side effects and they should have full blood counts (tests of the number of blood cells) before every dose of Adcetris. Treatment should continue for up to 1 year (16 cycles of treatment) unless the disease gets worse or severe side effects develop.

The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects. For further information, see the package leaflet.

How does Adcetris work?

The active substance in Adcetris, brentuximab vedotin, is made up of a CD30 monoclonal antibody (a type of protein that attaches to CD30). The monoclonal antibody is attached to monomethyl auristatin E, a cytotoxic (cell-killing) molecule. The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells, and once inside the cancer cells, it stops them from dividing, and the cancer cells eventually die.

How has Adcetris been studied?

The effects of Adcetris were first tested in experimental models before being studied in humans.

In HL, Adcetris has been studied in one main study in 102 patients with CD30-positive HL, who had previously received an autologous stem cell transplant and whose cancer had come back or had not responded to previous treatment. In addition, the company provided data on 40 patients with CD30-positive HL, whose cancer had come back or had not responded to at least two prior therapies and who are not eligible for autologous stem cell transplant or multi-agent chemotherapy. Adcetris was also compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back.

In sALCL, Adcetris has been studied in one main study in 58 sALCL patients whose cancer had come back or had not responded to treatment.

In the first HL study, and in the sALCL study, both involving patients whose disease had already come back or not responded, the main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and patients’ clinical data. A complete response is when a patient has no signs of the cancer. In the second HL study (in patients with HL at increased risk of progressing or coming back), the main measure of effectiveness was how long patients lived without their disease getting worse.

What benefit has Adcetris shown during the studies?

Hodgkin’s lymphoma

In a main study, Adcetris was used in 102 patients with CD30-positive HL, who had previously received an autologous stem cell transplant and whose cancer had come back or had not responded to previous treatment. The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and patients’ clinical data. A complete response is when a patient has no signs of cancer.In this study, 75% of patients (76 out of 102) responded partially or completely to treatment. A complete response was observed in 33% of patients (34 out of 102).

In addition, the company provided data on 40 patients with CD30-positive HL, whose cancer had come back or had not responded to at least two prior therapies and who were not eligible for autologous stem cell transplant or multi-agent chemotherapy. The data on these patients showed that 55% of patients (22 out of 40) responded to treatment. For 23% of these patients (9 out of 40) a complete response was observed.

In another main study, Adcetris was compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back. The main measure of effectiveness was how long patients lived without their disease getting worse. In this study, the average time patients lived before their disease got worse was around 43 months in those given Adcetris, compared with around 24 months in those given placebo. The benefit was sustained during 3 years of follow-up.

Systemic anaplastic large cell lymphoma

Adcetris was studied in 58 sALCL patients whose cancer had come back or had not responded to treatment. The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and patients’ clinical data. A complete response is when a patient has no signs of cancer. In this study, 86% of patients (50 out of 58) responded partially or completely to treatment and this response was complete for 59% (34 out of 58).

Cutaneous T-cell lymphoma

Adcetris has been shown to be of benefit in CD30-positive cutaneous T-cell lymphoma in a main study in 128 patients with CD30-positive CTCL who had had at least one previous treatment. The study compared treatment with Adcetris and treatment with another appropriate medicine (methotrexate or bexarotene). The proportion of patients whose disease responded to treatment for at least 4 months was 56% of those given Adcetris (36 of 64 patients) and 13% of those given alternative treatments (8 of 64 patients).

What are the risks associated with Adcetris?

The most frequent side effects (which may affect more than 1 in 10 people) are infections (including infections of the nose and throat) peripheral sensory or motor neuropathy (nerve damage that affects feeling or muscle control and co-ordination), tiredness, nausea (feeling sick), diarrhoea, fever, neutropenia (low white blood cell count), rash, cough, vomiting, joint pain, infusion-related reactions, itching, constipation, dyspnoea (difficulty breathing), weight loss, muscle pain and abdominal (belly) pain.

Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs. For the full list of all side effects and restrictions with Adcetris, see the package leaflet.

Why has Adcetris been approved?

The European Medicines Agency noted that, despite limited data and studies that did not compare Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy. In these patients, who generally have poor outcomes and lack suitable treatments, Adcetris could lead to a cure or could enable them to undergo potentially curative treatments. In addition, giving Adcetris to patients who have had a stem cell transplant and are considered at risk of the cancer progressing or coming back, resulted in a clear clinical benefit. In patients with CTCL a clinically significant benefit was seen over treatment with bexarotene or methotrexate. The Agency further noted that the overall safety profile of Adcetris was acceptable given the serious conditions for which it is used. Therefore, the Agency decided that Adcetris’ benefits are greater than its risks and recommended that it be approved for use in the EU.

Adcetris has been given ‘conditional approval’. This means that there is more evidence to come, especially about the medicine’s long-term effects, which are needed to confirm the positive benefit-risk balance. Every year, the Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Adcetris?

The company that markets the medicine will provide follow-up data on patients’ survival from the main studies submitted in HL and sALCL. In addition, the company will carry out two further studies on the benefits of the medicine and a safety study in a larger population of HL and sALCL patients.

What measures are being taken to ensure the safe and effective use of Adcetris?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adcetris have been included in the summary of product characteristics and the package leaflet.

Other information about Adcetris

The European Commission granted a marketing authorisation valid throughout the European Union for Adcetris on 25 October 2012.

For more information about treatment with Adcetris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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