Jaypirca

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.

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.

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 MCL or CLL. By blocking the action of BTK, the medicine is expected to slow the progression of the disease.

Mantle cell lymphoma

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.

Chronic lymphocytic leukaemia

One main study showed that Jaypirca is effective at delaying the worsening of CLL, compared with other cancer medicines. The study involved 238 patients with CLL who had been treated with a BTK inhibitor before and whose disease had come back or did not respond to previous treatments. Patients received either Jaypirca or a combination of other cancer medicines (rituximab given with either idelalisib or bendamustine). The study showed that patients taking Jaypirca lived on average for 14 months without the disease getting worse, compared with 9 months for patients given rituximab plus either idelalisib or bendamustine.

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 neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, diarrhoea, anaemia (low levels of red blood cells), rash and bruising.

Some side effects can be serious. The most frequent (which may affect up to 1 in 10 people) include pneumonia (infection of the lungs), neutropenia, anaemia, atrial fibrillation or atrial flutter (irregular and uncoordinated contractions or rapid contractions of the upper chambers of the heart) and urinary tract infection (infection of the parts of the body that collect and pass out 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, the European Medicines Agency 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. Jaypirca was also shown to be effective at delaying progression of CLL in patients whose disease came back or did not respond to previous treatments.

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 it has been authorised on the basis of less comprehensive data than are normally required because it fulfils an unmet medical need. The Agency considers that the benefit of having the medicine available earlier outweighs any risks associated with using it while awaiting further evidence.

The company must provide further data on Jaypirca. It must submit 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.

Every year, the Agency will review any new information that becomes available.

Jaypirca received a conditional marketing authorisation valid throughout the EU on 30 October 2023.