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Hibruka (orelabrutinib)
Australian Prescription Medicine Decision Summary
Hibruka has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). Hibruka contains the active ingredient orelabrutinib.
Published
Product name
Hibruka
Active ingredient
Orelabrutinib
Submission type
New chemical entity - Type A application
Decision
Approved for provisional registration in the Australian Register of Therapeutic Goods (ARTG)
Decision date
Registration date
What this medicine was approved for
Hibruka is provisionally approved to treat mantle cell lymphoma (MCL), a rare and aggressive type of non-Hodgkin lymphoma (a cancer that affects the lymph nodes).
It is used in adult patients who have had at least one prior treatment for their MCL, when:
- the cancer has come back (relapsed)
- previous treatment did not work or no longer works (refractory).
MCL is a serious, life-threatening disease with generally poor outcomes. Although many patients respond well to initial (first-line) chemo-immunotherapy, most patients relapse and require further treatment. There are few treatment options for relapsed or refractory MCL.
How this medicine works
Hibruka is a Bruton’s tyrosine kinase (BTK) inhibitor. BTK inhibitors work by blocking the BTK enzyme, a protein that helps certain cancer cells survive and grow.
By blocking BTK, Hibruka may reduce the number of cancer cells in MCL and may also slow the spread of the cancer.
Why the TGA approved or did not approve this medicine
The registration application for Hibruka included 2 clinical studies in patients with MCL who had received at least one prior treatment. These studies assessed effectiveness (how well the medicine works) and safety. Study ICP-CL-00102 included 86 patients, and study ICP-CL-00107 included 43 patients.
Effectiveness was measured using criteria for assessing treatment response in non-Hodgkin lymphoma, based on computed tomography (CT) and magnetic resonance imaging (MRI) scans. The studies assessed:
- complete response rate – the percentage of patients with no detectable evidence of MCL after treatment
- partial response rate – the percentage of patients whose MCL improved after treatment
- overall response rate – the total percentage of patients who had either a complete or partial response.
Additional safety information came from pooled data of 630 patients with B-cell cancers treated with Hibruka across 8 clinical studies, including studies ICP-CL-00102 and ICP-CL-00107.
Key findings from the clinical studies
- The overall response rate in study ICP-CL-00102 was 72.1%. This means MCL improved or could no longer be detected after treatment with Hibruka in about three-quarters of patients.
- The complete response rate was 33.7%, meaning MCL could no longer be detected after treatment with Hibruka in about one-third of patients.
- Findings from study ICP-CL-00107 were similar, with an overall response rate of 83.7% and a complete response rate of 39.5%.
- Across both studies, 38.8% of patients experienced serious adverse events (serious side effects or unexpected outcomes).
- The most common adverse events were thrombocytopenia (low platelet count), anaemia (low red blood cell count), upper respiratory tract infection, neutropenia (low neutrophil count, a type of white blood cell), rash, and diarrhoea.
- In the pooled safety data, the most common adverse events were thrombocytopenia, upper respiratory tract infection, neutropenia, anaemia, and COVID-19.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Hibruka and the medicine can be provisionally registered in Australia. Continued approval depends on additional clinical study data that must be submitted to the TGA for evaluation once the study is completed.
More detailed information on why the TGA provisionally approved Hibruka 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 may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
Consumer Medicine Information (CMI)
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 Hibruka can be accessed through the searchable TGA eBusiness Services or ARTG databases.
Product Information (PI)
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 Hibruka can be accessed through the searchable TGA eBusiness Services or ARTG databases.
ARTG details
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.
Treatment with Hibruka should be initiated and supervised by a physician experienced in the use of anticancer therapies.