Tremelimumab AstraZeneca
Authorised
This medicine is authorised for use in the European Union
tremelimumab
MedicineHumanAuthorised
Overview
Tremelimumab AstraZeneca is a cancer medicine for treating non-small cell lung cancer (NSCLC) that has metastasised (spread to other parts of the body) in adults who have not been treated before. It is given together with durvalumab (another cancer medicine) and platinum-based chemotherapy, and is used when the cancer has shown no mutations (changes) in the so-called EGFR and ALK genes.
Tremelimumab AstraZeneca contains the active substance tremelimumab.
Tremelimumab AstraZeneca can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in treating cancer.
Tremelimumab AstraZeneca is given as an infusion (drip) into a vein which lasts about an hour, in combination with durvalumab and chemotherapy. Treatment consists of a maximum of 5 doses, but may be stopped permanently if the cancer worsens or if the patient gets severe side effects.
For more information about using Tremelimumab AstraZeneca, see the package leaflet or contact your doctor or pharmacist.
The active substance in Tremelimumab AstraZeneca, tremelimumab, is a monoclonal antibody (a type of protein). It is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system (the body’s natural defences). By blocking CTLA-4, the medicine increases the number and activity of T cells, which can then kill cancer cells. This is expected to slow down the spread of the cancer.
In a main study in patients with metastatic NSCLC, 338 patients given Tremelimumab AstraZeneca in combination with durvalumab and chemotherapy lived on average for 14 months, compared with 12 months for 337 patients given only chemotherapy. They also lived longer without their disease getting worse: around 6 months on average, compared with 5 months for patients who only received chemotherapy.
The most common side effects with Tremelimumab AstraZeneca in combination with durvalumab and chemotherapy (which may affect more than 2 in 10 people) are anaemia (low levels of red blood cells), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), tiredness, rash, thrombocytopenia (low levels of platelets in the blood) and diarrhoea.
The most common serious side effects (which may affect more than 2 in 10 people) are neutropenia and anaemia. Other serious side effects (which may affect up to 1 in 10 people) are pneumonia (infection of the lungs), thrombocytopenia, leucopenia (low levels of white blood cells), tiredness, neutropenia with fever, colitis (inflammation of the large intestine) and increased levels of liver enzymes and lipase (an enzyme that helps digest fat, mainly made in the pancreas).
Tremelimumab AstraZeneca is commonly associated with side effects related to the activity of the immune system on body organs, such as immune-mediated hypothyroidism (an underactive thyroid gland) and colitis.
For the full list of side effects and restrictions of Tremelimumab AstraZeneca, see the package leaflet.
Tremelimumab AstraZeneca, when given in combination with durvalumab and chemotherapy, can prolong patients’ lives compared with chemotherapy only. Side effects of added Tremelimumab AstraZeneca, in particular concerning immune-mediated side effects, can be serious, and warrant caution when treating frail or elderly patients.
The European Medicines Agency decided that Tremelimumab AstraZeneca’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Tremelimumab AstraZeneca must provide healthcare professionals prescribing the medicine with educational materials on the side effects resulting from excessive activity of the immune system. Patients will also receive from their doctor an alert card summarising key safety information on the medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tremelimumab AstraZeneca have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Tremelimumab AstraZeneca are continuously monitored. Suspected side effects reported with Tremelimumab AstraZeneca are carefully evaluated and any necessary action taken to protect patients.
Tremelimumab AstraZeneca received a marketing authorisation valid throughout the EU on 20 February 2023.
Product information
Latest procedure affecting product information: IG1659
04/09/2023
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
- Tremelimumab AstraZeneca
- Active substance
- Tremelimumab
- International non-proprietary name (INN) or common name
- tremelimumab
- Therapeutic area (MeSH)
- Carcinoma, Non-Small-Cell Lung
- Anatomical therapeutic chemical (ATC) code
- L01FX20
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
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