Drug

HERCEPTIN®

Trastuzumab

Herceptin Overview

This is a summary of the European public assessment report (EPAR) for Herceptin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Herceptin.

Herceptin treatment should only be started by a doctor who has experience in the use of anticancer medicines.

When given as an infusion into a vein, Herceptin is given over 90 minutes every week or every three weeks for breast cancer, and every three weeks for gastric cancer. For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective. The recommended dose depends on the patient’s body weight and depends on the condition to be treated and whether Herceptin is given weekly or three-weekly.

The infusion can be associated with allergic reactions, so the patient should be monitored during and after the infusion. Patients who tolerate the first 90‑minute infusion can receive subsequent infusions over 30 minutes.

When given as an injection under the skin, the recommended dose of Herceptin does not depend on the patient’s body weight and is 600 mg given over 2 to 5 minutes every three weeks.

The active substance in Herceptin, trastuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found on certain cells in the body. Trastuzumab has been designed to attach to HER2, which is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow.

In the first study in early breast cancer, 8% of the patients who received Herceptin by infusion into a vein after having completed surgery, chemotherapy and radiotherapy (if applicable) experienced a reappearance of their cancer in the first year of treatment (127 out of 1,693), compared with 13% of the patients who did not receive it (219 out of 1,693). The addition of Herceptin to chemotherapy resulted in fewer patients experiencing a reappearance of their cancer over three years. The difference was between 4.8 and 11.8% depending on the type of chemotherapy. For locally advanced breast cancer, giving Herceptin by infusion into a vein before surgery in combination with chemotherapy and then again after surgery on its own resulted in fewer patients dying or having their cancer worsen or reappear over three years: after three years, 65% of patients given Herceptin were still alive without having their cancer worsen or reappear as compared to 52% in patients not given Herceptin.

In metastatic breast cancer, 15% of the patients whose previous treatment had failed responded to Herceptin given by infusion into a vein. When used in combination with paclitaxel or docetaxel, around half of the patients responded to Herceptin, compared with around a quarter of those receiving paclitaxel or docetaxel alone. Patients receiving Herceptin in combination with anastrozole also lived for longer without their cancer getting worse (4.8 months, on average) than those receiving anastrozole alone (2.4 months, on average).

In metastatic gastric cancer, the patients with higher levels of HER2 expression who received Herceptin by infusion into a vein survived for an average of 16.0 months, compared with 11.8 months in those receiving cisplatin and either capecitabine or 5‑fluorouracil alone.

When given by injection under the skin, Herceptin had the same effectiveness as when given by infusion into a vein. The levels of the active substance were at least as high as when Herceptin is given by infusion into a vein.

The CHMP decided that Herceptin’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin on 28 August 2000.

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

What is the risk associated with Herceptin?

The most common or serious side effects with Herceptin are heart problems, infections, lung and blood problems, and reactions related to the way Herceptin is given. In the study comparing Herceptin given under the skin and by infusion into a vein, some side effects have been reported more frequently with Herceptin given under the skin: infections with or without neutropenia (low levels of neutrophils, a type of white blood cells), heart problems, reactions related to the way Herceptin is given and high blood pressure. 

Herceptin must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients. It must not be used in patients who have serious breathing problems when they are at rest because of advanced cancer, or who need oxygen therapy.

Herceptin can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should). Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.

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

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