Talzenna
Authorised
This medicine is authorised for use in the European Union
talazoparib
MedicineHumanAuthorised
Overview
Talzenna is a cancer medicine used on its own to treat a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site, in patients who have been treated with certain medicines which have stopped working or when these medicines are not suitable.
Talzenna contains the active substance talazoparib.
Talzenna can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Talzenna is available as capsules (1 mg and 0.25 mg) and the recommended dose is 1 mg once a day. Treatment should continue for as long as the patient continues to benefit from it and side effects are tolerable. The dose may be reduced or treatment interrupted if certain side effects develop.
For more information about using Talzenna, see the package leaflet or contact your doctor or pharmacist.
The active substance in Talzenna, talazoparib, blocks the action of enzymes called human poly-ADP ribose polymerase (PARP), which are proteins that help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division. Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and as a result the cancer cells die.
Talzenna was shown to be effective at increasing the time patients live without their disease getting worse in one main study involving 431 patients with HER2-negative breast cancer with BRCA mutations whose cancer had spread. Patients treated with Talzenna lived on average for 8.6 months without their disease getting worse compared with 5.6 months for patients treated with the doctor's choice of another cancer medicine.
The most common side effects with Talzenna (which may affect more than 1 in 4 people) are tiredness, anaemia (low red blood cell counts which can cause tiredness and pale skin), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), thrombocytopenia (low blood levels of platelets), and headache. The most common severe side effects (which may affect more than 1 in 10 people) which led to changes in the dose of Talzenna are anaemia, neutropenia and thrombocytopenia.
Women must not breastfeed during treatment with Talzenna and for a month after stopping treatment. For the full list of side effects and restrictions with Talzenna, see the package leaflet.
Generally the outcome is poor for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread. Talzenna can increase the time these patients live without their disease getting worse. The side effects with Talzenna were generally well-tolerated and when needed, manageable with dose modifications, and/or standard supportive medical therapy.
The European Medicines Agency therefore decided that Talzenna’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talzenna have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Talzenna are continuously monitored. Side effects reported with Talzenna are carefully evaluated and any necessary action taken to protect patients.
Talzenna received a marketing authorisation valid throughout the EU on 20 June 2019.
Product information
Latest procedure affecting product information: R/0017
15/04/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Talzenna
- Active substance
- talazoparib
- International non-proprietary name (INN) or common name
- talazoparib
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01XK04
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Patient selection
Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method.
Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable.
Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.
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