ZanubrutinibBrukinsa
Treatment of relapsed or refractory mantle cell lymphoma (MCL), Waldenström macroglobulinaemia (WM), treatment-naïve and relapsed/refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
Decisions on record
- Meeting Nov 2025 Recommended Mantle cell lymphoma, Waldenstrom macroglobulinaemia, chronic lymphocytic leukaemia or small lymphocytic lymphoma
- Meeting Jul 2024 Recommended Waldenström macroglobulinaemia
- Meeting Mar 2023 Recommended Chronic lymphocytic leukaemia (CLL)/Small lymphocytic leukaemia (SLL); treatment naive CLL/SLL
- Meeting Mar 2023 Recommended Chronic lymphocytic leukaemia (CLL)/Small lymphocytic leukaemia (SLL); relapsed or refractory CLL or SLL
- Meeting Mar 2022 Recommended Waldenstrom macroglobulinemia
- Meeting Jul 2021 Not recommended Waldenstrom macroglobulinaemia
- Meeting Jul 2021 Recommended Relapsed/refractory mantle cell lymphoma
Access path
- TGA registered · Brukinsa
TGA label narrower than the PBS population
- Jul 2021Recommended · restricted
Comparator changed: ibrutinib → Rituximab monotherapy (treatment-naïve unsuitable for…
- Jul 2021Not recommended
Comparator changed: ibrutinib → Rituximab monotherapy (treatment-naïve unsuitable for…
- ↻ resubmittedMar 2022Recommended · restricted
Comparator changed: Rituximab monotherapy (treatment-naïve unsuitable for…
- Mar 2023Recommended
Comparator changed: Rituximab monotherapy (treatment-naïve population); bendamustine +…
- Mar 2023Recommended
Comparator changed: Rituximab monotherapy (treatment-naïve population); bendamustine +…
- Jul 2024Recommended
Evidence: RCT → Registry
- Nov 2025Recommended
Evidence: Registry → Single-arm
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of zanubrutinib (Brukinsa®) 160 mg tablet on the PBS under the same circumstances as the PBS-listed 80 mg capsule on a cost- minimisation basis. 5 OFFICIALPSD · Nov 2025
OFFICIAL Public Summary Document – November 2025 PBAC MeetingPSD · Nov 2025
6.53 The submission presented a cost-minimisation approach of zanubrutinib versus ibrutinib based on the claim of non-inferior effectiveness and safety. 21PSD · Mar 2023
6.54 The submission proposed the following equi-effective doses:PSD · Mar 2023
6.49 The submission described zanubrutinib as non-inferior in terms of effectiveness and safety compared to ibrutinib. The evaluation and the ESC considered this was reasonable.PSD · Mar 2023
6.50 The PBAC considered that the clinical claims of non-inferior effectiveness and safety for zanubrutinib versus ibrutinib were reasonably supported by the data.PSD · Mar 2023
4.4 In August 2023, the AIHW published comprehensive cancer statistics, including incidence and survival data, providing a more detailed understanding of cancer subtypes for the period of 2003 – 2019 (AIHW 2023a). These new data allowed for the identification of individual haematological subtypes, such as WM.PSD · Jul 2024
4.6 In March 2022, the incidence rate of 0.37 per 100,000 population for WM could not be verified due to the absence of reliable Australian data specific to the WM subset (see paragraph 4.3). To support this incidence base case, the sponsor provided a rationale that the incidence of WM could be derived using the AIHW 2017 data indicating the incidence of non-Hodgkin lymphoma (NHL) in Australia (19.8 per 100,000) and assuming WM accounted for 1 - 2% of NHL …PSD · Jul 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the 160 mg tablet is claimed to be bioequivalent to the 80 mg capsule with identical daily cost.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because zanubrutinib 160 mg tablet is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over zanubrutinib 80 mg capsule, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 for Pricing Pathway A were not met. PBAC · 2025
Decision context
PopulationAdults with relapsed or refractory mantle cell lymphoma, Waldenström macroglobulinaemia, treatment-naïve chronic lymphocytic leukaemia or small lymphocytic lymphoma, and those with relapsed/refractory CLL/SLL.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | zanubrutinib 80 mg capsule | — | Single-arm · Bioequivalence |
| Jul 2024 | Recommended | — | — | Registry |
| Mar 2023 | Recommended | ibrutinib | — | RCT · PFS |
| Mar 2023 | Recommended | venetoclax + obinutuzumab | — | RCT · PFS |
| Mar 2022 | Recommended · restricted | Rituximab monotherapy (treatment-naïve population); bendamustine + rituximab (relapsed/refractory population) | — | RCT · ORR |
| Jul 2021 | Recommended · restricted | ibrutinib | — | Single-arm · ORR |
| Jul 2021 | Not recommended | Rituximab monotherapy (treatment-naïve unsuitable for chemo-immunotherapy); Bendamustine + rituximab (relapsed/refractor | — | RCT · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ASPEN | Ph 3 | 201 | Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial … | completed |
| ASPEN (Phase 3, BGB-3111-302) | Ph 3 | 780 | Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC) | recruiting |
Consumer voice
Consumer input from individuals and healthcare professionals highlighted benefits of zanubrutinib including ease of use, efficacy, tolerability, reduced hospital visits, and improved quality of life through return to work and community participation. Comments also noted the difficulty of 'watch and wait' approach for asymptomatic patients.
the ease of taking zanubrutinib, efficacy, high tolerability, the potential for reduced hospital visits, and the opportunity for improved quality of life through the ability to return to work and participate in the community Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts MCL to relapsed/refractory only, whereas TGA label permits treatment-naïve MCL.