Jaypirca (pirtobrutinib)
Jaypirca is approved for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have been previously treated with a Bruton's tyrosine kinase (BTK) inhibitor. Jaypirca contains the active ingredient pirtobrutinib.
Jaypirca is used as monotherapy (on its own) to treat chronic lymphocytic leukemia/small lymphocytic lymphoma in adults previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
Lymphocytic leukemia/small lymphocytic lymphoma is a cancer affecting B cells (a type of white blood cell) called lymphocytes.
This medicine is used when the cancer has come back (relapsed), or when previous treatment has not worked or has stopped working (refractory).
Jaypirca is a cancer medicine that works by blocking BTK. BTK is a protein that allows certain types of cancer cells to grow, including abnormal B cells, in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. By blocking BTK, the progression of the cancer may slow down.
The effectiveness and safety of Jaypirca were supported by one main clinical study and one supporting study.
The main clinical study compared the effectiveness and safety of Jaypirca to other cancer medicines (rituximab given with either idelalisib or bendamustine). This study included patients previously treated for chronic lymphocytic leukemia/small lymphocytic lymphoma.
The study showed a delay in the progression of the cancer.
Key findings from clinical studies
- Patients given Jaypirca lived for an average of 14.0 months without the disease getting worse, compared to an average of 8.7 months for those given other cancer medicines.
- Patients given Jaypirca had a similar incidence of serious adverse events (side effects, faults or unwanted outcomes), but a lower incidence of severe (Grade 3) or life-threatening (Grade 4) adverse events, and lower incidence of treatment discontinuation due to adverse events compared with patients given other cancer medicines.
- The most common side effects of Jaypirca were pneumonia (inflammation of the lungs), anaemia (low level of red blood cells), neutropenia (low level of neutrophils, a type of white blood cell), cough and diarrhoea.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Jaypirca and the medicine can be registered in Australia.
More detailed information on why the TGA approved Jaypirca will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and therefore may not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Jaypirca can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Jaypirca can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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