Active Substance: pertuzumab
Common Name: pertuzumab
ATC Code: L01XC13
Marketing Authorisation Holder: Roche Registration Limited
Active Substance: pertuzumab
Authorisation Date: 2013-03-04
Therapeutic Area: Breast Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents, monoclonal antibodies
Metastatic Breast Cancer:
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.
Neoadjuvant Treatment of Breast Cancer:
Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
What is Perjeta and what is it used for?
Perjeta is a cancer medicine for treating adults with ‘HER2-positive’ breast cancer (where a protein called ‘HER2’ is found on the cancer cells).
Perjeta is used for metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery. In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines).
It is also used for neoadjuvant treatment (treatment to shrink the cancer) in locally advanced, inflammatory or early-stage cancer at high risk of coming back. In these cases, Perjeta is used with trastuzumab and chemotherapy before the patient undergoes surgery.
Perjeta contains the active substance pertuzumab.
How is Perjeta used?
Perjeta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who is experienced in using cancer medicines and in a hospital setting where resuscitation equipment is available. The HER2-positive status of the patient’s cancer must be confirmed by suitable tests before starting treatment with Perjeta.
Perjeta is available as a concentrate to be made into a solution for infusion (drip) into a vein. The recommended first dose is 840 mg given over one hour. This is followed by a dose of 420 mg every three weeks, with each dose given over half an hour to one hour. When used for earlier stages of breast cancer, treatment with Perjeta should continue until the patient has surgery. For metastatic cancer, treatment should continue until the disease gets worse or the side effects become unmanageable. Treatment with Perjeta should be stopped permanently if the patient gets certain side effects.
How does Perjeta work?
The active substance in Perjeta, pertuzumab, is a monoclonal antibody, a type of protein that has been designed to attach to HER2, a protein found on HER2-positive cancer cells. By attaching to HER2, pertuzumab stops HER2 producing signals that cause the cancer cells to grow. It also activates cells of the immune system (the body’s natural defences), which then kill the cancer cells.
What benefits of Perjeta have been shown in studies?
Perjeta has been studied in one main study involving 808 adults with previously untreated HER2-positive metastatic breast cancer. The effects of Perjeta were compared with placebo (a dummy treatment) when given together with other cancer 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). Patients treated with Perjeta lived for 18.5 months without their disease getting worse, compared with 12.4 months for patients given placebo.
Perjeta has also been studied in two main studies involving a total of 642 patients with earlier stages of breast cancer who were to undergo surgery. In these studies, Perjeta was given with trastuzumab or chemotherapy or both. The studies looked at how many patients responded to treatment (i.e. patients who had no cancer cells in the breast after surgery). In the first study, 46% of the patients treated with Perjeta plus trastuzumab and docetaxel responded to treatment, compared with 29% of patients who received trastuzumab and docetaxel alone. Response to treatment was also high in the second study (ranging from 57% to 66%) where Perjeta was given with trastuzumab and different chemotherapy medicines.
What are the risks associated with Perjeta?
The most common side effects (affecting more than 1 in 10 people) with Perjeta when given with trastuzumab and chemotherapy are upper respiratory tract infection (infection of the nose and throat), nasopharyngitis (inflammation of the nose and throat), neutropenia and febrile neutropenia (low levels of neutrophils, a type of white blood cell important for fighting infections, with or without fever), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), hypersensitivity (allergic) reactions and other reactions at the infusion site, decreased appetite, insomnia (difficulty sleeping), peripheral neuropathy (nerve damage in the hands and feet causing tingling or numbness), headache, dysgeusia (taste disturbances), cough, diarrhoea, vomiting, constipation, dyspepsia (heartburn), alopecia (hair loss), nausea (feeling sick), rash, nail disorder, muscle and joint pain, inflammation of moist body surfaces and of the moist tissue that lines certain body cavities, pain, oedema (swelling), pyrexia (fever), tiredness and weakness.
For the full list of all side effects and restrictions with Perjeta, see the package leaflet.
Why is Perjeta approved?
HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases. The European Medicines Agency considered that Perjeta has been shown to benefit patients with metastatic cancer 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. Perjeta has also been shown to improve the outcome of patients with earlier stages of breast cancer, when used with trastuzumab and chemotherapy. The Agency considered that, despite the side effects reported with Perjeta, the overall safety profile was acceptable.
What measures are being taken to ensure the safe and effective use of Perjeta?
The company that markets Perjeta will carry out a study to assess the effects of using Perjeta and trastuzumab together with a type of cancer medicines called taxanes, in previously untreated patients with HER2-positive metastatic or locally advanced breast cancer.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Perjeta have also been included in the summary of product characteristics and the package leaflet.
Other information about Perjeta
The European Commission granted a marketing authorisation valid throughout the European Union for Perjeta on 4 March 2013.
For more information about treatment with Perjeta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.