Jaypirca

Authorised

This medicine is authorised for use in the European Union

pirtobrutinib

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.

How is Jaypirca used?

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.

How does Jaypirca work?

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.

What benefits of Jaypirca have been shown in studies?

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.

What are the risks associated with Jaypirca?

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).

What measures are being taken to ensure the safe and effective use of Jaypirca?

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.

Other information about Jaypirca

Jaypirca received a conditional marketing authorisation valid throughout the EU on 31 October 2023.

Jaypirca : EPAR - Medicine overview

Reference Number: EMA/212725/2023

Jaypirca : EPAR - Risk management plan

Product information

Jaypirca : EPAR - Product information

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).

Jaypirca : EPAR - All authorised presentations

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)

Authorisation details

• EMA product number:
  EMEA/H/C/005863
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Marketing authorisation holder:
  Eli Lilly Nederland B.V.

  Papendorpseweg 83; 3528 BJ Utrecht; NETHERLANDS

• Opinion adopted:
  26/04/2023
• Marketing authorisation issued:
  30/10/2023

Assessment history

Initial marketing authorisation documents

Jaypirca : EPAR - Orphan maintenance assessment report - initial authorisation

AdoptedReference Number: EMA/OD/0000124200

Jaypirca : EPAR - Public assessment report

AdoptedReference Number: EMA/308908/2023

CHMP summary of positive opinion for Jaypirca

AdoptedReference Number: EMA/167799/2023