Copiktra
Authorised
This medicine is authorised for use in the European Union
duvelisib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Copiktra is a cancer medicine used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).
In CLL, Copiktra is used in patients whose disease has either come back or not improved after at least two other treatments. In follicular lymphoma, it is used in patients whose disease has not improved after at least two other treatments.
Copiktra contains the active substance duvelisib.
Copiktra can only be obtained with a prescription and it should be prescribed by a doctor experienced in the use of cancer medicines.
Copiktra is available as capsules to be taken by mouth; the recommended dose is 25 mg twice a day. Treatment should be continued for as long as the patient improves or remains stable and the side effects are tolerable. The doctor may reduce the dose or stop treatment temporarily or permanently if certain side effects occur. The dose may also need to be reduced in patients taking other medicines that increase the amount of duvelisib in the body.
Any infection should be treated before starting treatment with Copiktra and patients should also be monitored for infection during Copiktra treatment.
For more information about using Copiktra, see the package leaflet or contact your doctor or pharmacist.
The active substance in Copiktra, duvelisib, blocks the effects of certain enzymes (called PI3K-delta and PI3K-gamma) that are overactive in blood cancers. These enzymes enable the growth and survival of the cancer cells. By blocking the effects of the enzymes, duvelisib causes the cancer cells to die, thereby delaying or stopping the progression of the cancer.
A main leukaemia study showed that Copiktra was more effective than another cancer medicine, ofatumumab, in patients with CLL that had not improved or had come back after at least 2 other treatments. Among the 196 such patients in the study, those treated with Copiktra lived on average 16 months before the cancer got worse compared with 9 months in those treated with ofatumumab.
In a second main study of lymphoma, Copiktra was effective in producing a response in patients with follicular lymphoma whose cancer had not improved after 2 previous treatments: 40% of these patients (29 of 73) responded to treatment.
The most common side effects with Copiktra (which may affect more than 2 in 10 people) are diarrhoea or colitis (inflammation in the large bowel), neutropenia (low levels of neutrophils, a type of white blood cell), rash, tiredness, fever, cough, nausea (feeling sick), upper respiratory tract infection (nose and throat infection), pneumonia (infection of the lungs), musculoskeletal pain (pain in the muscle and bones) and anaemia (low red blood cell count).
The most common serious side effects were pneumonia, colitis and diarrhoea.
For the full list of side effects and restrictions with Copiktra, see the package leaflet.
Copiktra was shown to be effective in delaying worsening of the disease in patients with CLL that had not improved or had come back after at least 2 previous treatments. In addition, the medicine was effective in patients with follicular lymphoma that had not improved after at least 2 previous treatments. The safety of Copiktra was considered acceptable. The European Medicines Agency therefore decided that Copiktra’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 Copiktra have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Copiktra are continuously monitored. Side effects reported with Copiktra are carefully evaluated and any necessary action taken to protect patients.
Copiktra received a marketing authorisation valid throughout the EU on 19 May 2021
Product information
Latest procedure affecting product information:
IB/0007/G
10/08/2023
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
- Copiktra
- Active substance
- duvelisib
- International non-proprietary name (INN) or common name
- duvelisib
- Therapeutic area (MeSH)
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma, Follicular
- Anatomical therapeutic chemical (ATC) code
- L01EM04
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Copiktra monotherapy is indicated for the treatment of adult patients with:
- Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies.
- Follicular lymphoma (FL) that is refractory to at least two prior systemic therapies.
News on Copiktra
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