Drug

ADCETRIS®

brentuximab vedotin

Adcetris Overview

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). Adcetris is used when the tumour cells are CD30-positive (when they have a protein called CD30 on their surface) and is given:

  • together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in HL patients who have stage IV disease (advanced cancer that has spread to other parts of the body) that has not been treated before;

  • 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.

    These diseases are rare, and Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) on various dates. Further information on the orphan designations can be found on the European Medicines Agency’s website (Hodgkin’s lymphoma: 15 January 2009; Anaplastic large cell lymphoma: 15 January 2009; Cutaneous T-cell lymphoma: 11 January 2012).

    Adcetris contains the active substance brentuximab vedotin.

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 depends on body weight and whether Adcetris is given with other cancer medicines. The medicine is given by a 30 minute infusion (drip) into a vein every 2 or 3 weeks. When given with other cancer medicines, patients may also be given a medicine to help prevent neutropenia (low white blood cell count). 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 6 months when used with other cancer medicines or up to 1 year when used alone.

The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects. For more information about using Adcetris, see the package leaflet or contact your doctor or pharmacist.

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.

Hodgkin’s lymphoma

In a main study of 1334 patients with CD30-positive HL who had not received previous treatment, Adcetris was compared with bleomycin (another HL medicine) when each was given with other cancer medicines (doxorubicin, vinblastine and dacarbazine). The main measure of effectiveness was how long patients lived without their disease getting worse. After 2 years, 82% of patients given Adcetris survived without their disease getting worse, compared with 77% of patients given bleomycin.

In another 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 2 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).

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. Previously untreated patients with advanced HL also benefited from Adcetris used in combination with other cancer medicines. 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 the benefits of Adcetris 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 overview will be updated as necessary.

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.

As for all medicines, data on the use of Adcetris are continuously monitored. Side effects reported with Adcetris are carefully evaluated and any necessary action taken to protect patients.

What are the risks associated with Adcetris?

The most common side effects of Adcetris given alone (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, rash, cough, vomiting, joint pain, infusion-related reactions, itching, constipation, dyspnoea (difficulty breathing), weight loss, muscle pain and abdominal (belly) pain. For the full list of all side effects with Adcetris, including side effects when used with doxorubicin, vinblastine and dacarbazine, see the package leaflet.

Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs.

Owner of copyright and other intellectual property rights to European Medicines Agency

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