Calquence
Authorised
This medicine is authorised for use in the European Union
acalabrutinib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Calquence is a cancer medicine used in adults to treat:
- chronic lymphocytic leukaemia (CLL), a blood cancer affecting B cells (a type of white blood cell). Calquence is used on its own (monotherapy) in patients with CLL who have had previous treatment. In patients who have not had previous treatment, Calquence may be used on its own or combined with another cancer medicine, obinutuzumab;
- mantle cell lymphoma (MCL; a blood cancer affecting B cells). Calquence is used on its own in patients whose MCL has come back (relapsed) or not responded (refractory) to treatment and who have not received treatment with a type of cancer medicine called a Bruton’s tyrosine kinase (BTK) inhibitor. It is also used in combination with other cancer medicines, bendamustine and rituximab, in adults with previously untreated MCL who cannot have an autologous stem cell transplantation (ASCT). An ASCT is a procedure where the patient’s bone marrow is replaced by their own stem cells to form new bone marrow that produces healthy cells.
Calquence contains the active substance acalabrutinib.
Calquence can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in the use of cancer medicines. It is available as capsules to be taken by mouth; the recommended dose is 100 mg taken twice a day. Calquence is continued as long as the cancer remains under control and there are no unacceptable side effects. Treatment may be interrupted or stopped, or the dose modified, if serious side effects occur or certain other medicines have to be taken.
For more information about using Calquence, see the package leaflet or contact your doctor or pharmacist.
The active substance in Calquence, acalabrutinib, blocks an enzyme called Bruton's tyrosine kinase, which helps B cells to survive and grow. By blocking this enzyme, acalabrutinib is expected to slow down the build-up of cancerous B cells in CLL, thereby delaying progression of the cancer.
Chronic lymphocytic leukaemia
Two main studies have shown that Calquence is effective at delaying death or the worsening of the disease.
The first study, involving 535 patients who had not had previous treatment for CLL, compared Calquence given on its own or in combination with obinutuzumab to a combination of obinutuzumab with another cancer medicine, chlorambucil. After around 28 months, 8% of the patients given Calquence in combination with obinutuzumab and 15% of those given Calquence alone had died or their cancer had got worse, compared with 53% of patients given obinutuzumab and chlorambucil.
The second study, involving 310 patients, compared Calquence given on its own with a combination of other cancer medicines (rituximab and either idelalisib or bendamustine) in patients whose CLL had come back or not responded to previous treatment. After around 16 months, 17% of patients given Calquence had died or their cancer had got worse, compared with 44% of those given the rituximab combinations.
Mantle cell lymphoma
In a study involving 124 adults with MCL that had come back or not responded to previous treatment, and who had not received treatment with a BTK inhibitor, around 82% of patients (101 out of 124) responded to treatment with Calquence. These patients lived for an average of 29 months without their disease getting worse. The study did not compare Calquence with another medicine or placebo (a dummy treatment).
A second study, involving 598 adults aged 65 years and older with previously untreated MCL, showed that Calquence given in combination with bendamustine and rituximab is more effective than placebo with bendamustine and rituximab at delaying death or worsening of the cancer. Patients given Calquence lived on average for 66.4 months without their cancer getting worse compared with 49.6 months for patients given placebo.
For the full list of side effects and restrictions with Calquence, see the package leaflet.
The most common side effects with Calquence (which may affect more than 1 in 5 people) include infections, headache, diarrhoea, bruising, musculoskeletal pain (pain in the muscles and bones), nausea (feeling sick), tiredness, cough, joint pain and rash.
When Calquence is used in combination with obinutuzumab the most common side effects (which may affect more than 1 in 5 people) include infections, musculoskeletal pain, diarrhoea, headache, leucopenia (low levels of white blood cells), neutropenia (low levels of neutrophils, a type of white blood cell), cough, tiredness, joint pain, nausea, dizziness and constipation.
When Calquence is used in combination with bendamustine and rituximab, the most common side effects (which may affect more than 1 in 5 people) include neutropenia, nausea, rash, diarrhoea, musculoskeletal pain, headache, tiredness, vomiting, constipation, anaemia (low levels of red blood cells) and thrombocytopenia (low levels of blood platelets, components that help the blood to clot).
Calquence showed clear benefits in patients with CLL, whether used on its own or in combination with obinutuzumab, in patients who had not received previous treatment. These results were considered clinically relevant. Even though the studies involved older patients and those with other illnesses, the results are likely to apply to younger and fitter patients too.
Most patients with previously untreated MCL who are older than 65 years are not able to undergo intensive treatments that are part of ASCT. Furthermore, there is an unmet medical need for patients with previously untreated MCL as there is no curative treatment available. The use of Calquence with bendamustine and rituximab delayed death or worsening of the cancer, that was considered to be valuable for patients.
Patients with MCL whose disease has come back or not responded to treatment with first-line therapy (the first treatment given for a disease) have poor outcomes and limited treatment options. The response rate to treatment with Calquence was found to be high and those who received the medicine had a durable response. However, there were some uncertainties due to the lack of comparator in the main study.
Calquence’s side effects are considered acceptable and in line with those of other medicines that work in the same way.
The European Medicines Agency therefore decided that Calquence’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 Calquence have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Calquence are continuously monitored. Side effects reported with Calquence are carefully evaluated and any necessary action taken to protect patients.
Calquence received a marketing authorisation valid throughout the EU on 5 November 2020.
Product information
Latest procedure affecting product information:
II/0025
02/05/2025
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
- Calquence
- Active substance
- acalabrutinib
- International non-proprietary name (INN) or common name
- acalabrutinib
- Therapeutic area (MeSH)
- Leukemia, Lymphocytic, Chronic, B-Cell
- Anatomical therapeutic chemical (ATC) code
- L01EL02
Pharmacotherapeutic group
Antineoplastic agents, protein kinase inhibitorsTherapeutic indication
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.
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