This is a summary of the European public assessment report (EPAR) for Perjeta. 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 Perjeta.
- What is Perjeta?
Perjeta is a medicine that contains the active substance pertuzumab. It is available as a concentrate to be made into a solution for infusion (drip) into a vein.
- What is Perjeta used for?
Perjeta is used to treat adults with breast cancer which is ‘HER2-positive’ (where a specific protein called ‘HER2’ is found on the surface of the cancer cells) and is metastatic (has spread to other parts of the body) or has come back after treatment and cannot be removed by surgery. It is only used in patients whose metastatic breast cancer has not already been treated with chemotherapy (anticancer medicines) or medicines designed to attach to HER2. It is used together with trastuzumab and docetaxel (other anticancer medicines).
The medicine can only be obtained with a prescription.
- How is Perjeta used?
Treatment with Perjeta should only be started under the supervision of a doctor who is experienced in using anticancer medicines and in a hospital setting where resuscitation equipment is available. The HER2-positive status of the patient’s cancer must be determined in advance of treatment with Perjeta by suitable tests.
Perjeta is given by infusion into a vein. The recommended first dose is 840 mg given over a period of one hour. This is followed by a dose of 420 mg every three weeks given over a period of half an hour to one hour. Treatment should continue until the disease gets worse or until the side effects become unmanageable. Treatment should be temporarily interrupted if the patient experiences certain side effects.
- How does Perjeta work?
The active substance in Perjeta, pertuzumab, 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. Pertuzumab has been designed to recognise and attach to HER2, a protein found on the surface of HER2-positive cancer cells. By attaching to HER2, pertuzumab stops HER2 producing signals that cause the cancer cells to grow, eventually killing them. It also activates cells of the immune system, which then kill the cancer cells.
- How has Perjeta been studied?
The effects of Perjeta were first tested in experimental models before being studied in humans.
Perjeta was studied in one main study involving 808 adults with previously untreated HER2-postive metastatic breast cancer. The effects of Perjeta were compared with placebo (a dummy treatment) when given together with other anticancer medicines (trastuzumab and docetaxel). The patients were treated until their disease got worse or the side effects of treatment became unmanageable. The main measure of effectiveness was progression free survival (how long the patients lived without their disease getting worse).
- What benefit has Perjeta shown during the studies?
Patients treated with Perjeta lived for longer without their disease getting worse than patients given placebo. On average, patients treated with Perjeta lived for 18.5 months without their disease getting worse, compared with 12.4 months for patients given placebo.
- What is the risk associated with Perjeta?
The most common side effects with Perjeta given with trastuzumab and docetaxel are diarrhoea, alopecia (hair loss) and neutropenia (low white blood cell counts), which experienced by more than half of all patients. The most common serious side effects are febrile neutropenia (low white blood cell counts with fever) as well as serious diarrhoea and neutropenia. Several other side effects are seen in more than 1 patient in 10. For the full list of all side effects reported with Perjeta, see the package leaflet.
Perjeta must not be used in people who are hypersensitive (allergic) to pertuzumab or any of the other ingredients.
- Why has Perjeta been approved?
The CHMP noted that HER2-positive breast cancer is an aggressive form which occurs in around one in five cases of breast cancer. The Committee considered that Perjeta had been shown to benefit patients by extending the amount of time patients lived without their disease getting worse as well as how long they lived. It considered that this would provide an additional benefit when added to other medicines for HER2-positive cancer, notably trastuzumab. The CHMP considered that, despite the side effects reported with Perjeta, the overall safety profile was acceptable. Therefore the CHMP decided that Perjeta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- What measures are being taken to ensure the safe use of Perjeta?
The company that markets Perjeta will carry out two studies to assess the effects of using Perjeta and trastuzumab together with two different types of anticancer medicine, in patients with HER2-positive breast cancer who are at certain stages of disease and at certain stages of treatment.
- Other information about Perjeta
The European Commission granted a marketing authorisation valid throughout the European Union for Perjeta on 4 March 2013.
This EPAR was last updated on 02/04/2013 .
14/12/2012 Perjeta -EMEA/H/C/002547 --
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Antineoplastic agents, monoclonal antibodies
Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Changes since initial authorisation of medicine
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Initial marketing-authorisation documents
This medicine is approved for use in the European Union