For doctors

What is it?

Herceptin is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance trastuzumab.

What is it used for?

Herceptin is used to treat the following types of cancer:

Herceptin can only be used when the cancer has been shown to ‘overexpress’ HER2: this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells.

The medicine can only be obtained with a prescription.

How is it used?

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

Herceptin is given as a 90-minute infusion 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 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.

How does it work?

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. 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. About a quarter of breast cancers and a fifth of gastric cancers overexpress HER2.

How has it been studied?

In early breast cancer, Herceptin has been studied in four main studies involving around 10,000 patients. The first study was in patients who had first been treated with surgery, chemotherapy and radiotherapy (if applicable). Half of the patients received Herceptin, while the other half did not receive it. The other three studies looked at the effects of giving Herceptin earlier in treatment, in combination with chemotherapy. All of these studies measured how many patients had their cancer re-appear within in the body.

In metastatic breast cancer, Herceptin has been studied in four main studies: one looked at Herceptin on its own in 222 patients whose previous treatment had failed; two looked at Herceptin in combination with paclitaxel or docetaxel in a total of 657 patients; and one looked at the combination of Herceptin and anastrozole (an aromatase inhibitor) in 208 women who had been through the menopause. These studies measured how many patients responded to treatment, or how long they lived without their cancer getting worse.

In metastatic gastric cancer, Herceptin in combination with cisplatin and either capecitabine or 5-fluorouracil was compared with the same combination but without Herceptin in one main study involving 594 patients. The main measure of effectiveness was how long the patients survived.

All of the studies were in patients whose cancers expressed HER2.

What benefits has it shown during the studies?

In the first study in early breast cancer, 8% of the patients who received Herceptin after having completed surgery, chemotherapy and radiotherapy (if applicable) experienced a re-appearance 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 re-appearance of their cancer over three years. The difference was between 4.8 and 11.8% depending on the type of chemotherapy.

In metastatic breast cancer, 15% of the patients whose previous treatment had failed responded to Herceptin. 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 survived for an average of 16.0 months, compared with 11.8 months in those receiving cisplatin and either capecitabine or 5-fluorouracil alone.

What is the risk associated?

The most common side effects with Herceptin (seen in more than 1 patient in 10) are febrile neutropenia (low levels of neutrophils, a type of white blood cell that fights infections, together with fever), tremor (shaking), dizziness, headache, decreased blood pressure, increased blood pressure, irregular heart beat, palpitations (a rapid or irregular heartbeat), cardiac flutter (rapid contractions of the heart), decreased ejection fraction (blood pumped out of the heart), wheezing, dyspnoea (difficulty breathing), diarrhoea, vomiting, nausea (feeling sick), lip swelling, abdominal pain (stomach ache), erythema (reddening of the skin), rash, face swelling, arthralgia (joint pain), muscle tightness, myalgia (muscle pain), asthenia (weakness), chest pain, chills, fatigue (tiredness), influenza (flu)-like symptoms, pain and pyrexia (fever). Side effects related to the infusion itself, such as chills, fever, rash, nausea and vomiting, tend to happen during the first few infusions before becoming less common. For the full list of all side effects reported with Herceptin, see the package leaflet.

Herceptin should not be used in people who may be 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 their 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 treatment to check their heart.

Why has it been approved?

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

How has it been studied?

The company that makes Herceptin is carrying out more studies looking at cardiotoxicity, including looking at the guidance supplied to doctors and how to identify patients at risk of heart problems to ensure that they are carefully monitored.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin to Roche Registration Limited on 28 August 2000. The marketing authorisation is valid for an unlimited period. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Herceptin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011.

Name

Herceptin 150 mg powder for concentrate for solution for
infusion

Composition

One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.

The reconstituted Herceptin solution contains 21 mg/ml of trastuzumab.

For a full list of excipients, (see section 6.1).

Pharmaceutical Form

Powder for concentrate for solution for infusion.

Herceptin is a white to pale yellow lyophilised powder.