Jaypirca
Authorised
This medicine is authorised for use in the European Union
pirtobrutinib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Jaypirca is a cancer medicine used to treat adults with mantle cell lymphoma (a cancer of B cells, a type of white blood cell) whose cancer has come back (relapsed) or no longer responds to treatment (refractory), and who had previously received a type of cancer medicine called a Bruton’s tyrosine kinase (BTK) inhibitor.
Mantle cell lymphoma is rare, and Jaypirca was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 June 2021. Further information on the orphan designation can be found on the EMA website.
Jaypirca contains the active substance pirtobrutinib.
Jaypirca can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
The medicine is available as tablets to be taken by mouth once daily. Treatment should be continued until the disease gets worse or the patient gets unacceptable side effects.
For more information about using Jaypirca, see the package leaflet or contact your doctor or pharmacist.
The active substance in Jaypirca, pirtobrutinib, works by blocking an enzyme called BTK, which is important for the growth of B cells, including the abnormal B cells in patients with mantle cell lymphoma. By blocking the action of BTK, the medicine is expected to slow the progression of the disease.
In a main study, Jaypirca was found to reduce the amount of cancer in the body or remove all signs of cancer in patients with MCL whose cancer had come back or did not respond to previous treatments, including with a BTK inhibitor.
The main study involved 164 patients with MCL and the main analysis involved 90 patients who had been treated with a BTK inhibitor before and whose disease could be assessed using a scan. Jaypirca was not compared with another treatment in this study.
Around 57% of patients (51 out of 90) had either a complete or partial response to Jaypirca, which means there was either no sign of the cancer left or the amount of cancer in the body had decreased after treatment. Around 19% had a complete response (17 out of 90). The response to treatment lasted on average 18 months.
For the full list of side effects and restrictions with Jaypirca, see the package leaflet.
The most common side effects with Jaypirca (which may affect more than 1 in 10 people) include tiredness, neutropenia (low levels of neutrophils, a type of white blood cell), diarrhoea and bruising.
The most common serious side effects (which may affect up to 1 in 10 people) include pneumonia (infection of the lungs), neutropenia, anaemia (low levels of red blood cells) and urinary tract infection (infection of the structures that carry urine).
Patients with MCL whose cancer has come back after previous treatments, including treatment with a BTK inhibitor, have few treatment options and a poor prognosis. Although data on Jaypirca at the time of authorisation were limited due to the small number of patients involved in the main study and the absence of a comparator, EMA considered that the proportion of patients who had a response to treatment and the average duration of this response represent a meaningful health benefit for patients with this aggressive form of cancer.
In addition, the side effects of Jaypirca were considered manageable and appeared to be similar to those of other authorised BTK inhibitors.
Jaypirca has been given ‘conditional authorisation’. This means that EMA decided that the benefits of Jaypirca are greater than its risks, but the company will have to provide additional evidence after authorisation.
Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the Agency will review any new information that becomes available until data become comprehensive and this overview will be updated as necessary.
Since Jaypirca was given conditional authorisation, at the time of authorisation the company marketing Jaypirca was required to provide the results of an ongoing study comparing Jaypirca with another BTK inhibitor in patients with MCL who had not been treated with a BTK inhibitor before.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jaypirca have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Jaypirca are continuously monitored. Suspected side effects reported with Jaypirca are carefully evaluated and any necessary action taken to protect patients.
Jaypirca received a conditional marketing authorisation valid throughout the EU on 31 October 2023.
Product information
Latest procedure affecting product information:
R/0004
16/08/2024
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
- Jaypirca
- Active substance
- pirtobrutinib
- International non-proprietary name (INN) or common name
- pirtobrutinib
- Therapeutic area (MeSH)
- Lymphoma, Mantle-Cell
- Anatomical therapeutic chemical (ATC) code
- L01
Pharmacotherapeutic group
- Antineoplastic agents
- Protein kinase inhibitors
Therapeutic indication
Treatment of mantle cell lymphoma (MCL)
News on Jaypirca
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