Therapy Areas: Respiratory
BeiGene Touts First Regulatory Approval in Australia for Brukinsa for Treatment of Patients with Waldenström's Macroglobulinemia
7 October 2021 - - Brukinsa (zanubrutinib) has been approved in Australia for the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy, China-based biotechnology company BeiGene (NASDAQ: BGNE) (HKEX: 06160) said.

Following registration of Brukinsa with the Therapeutic Goods Administration, these patients will have immediate access to Brukinsa through a BeiGene sponsored post-approval, pre-reimbursement access program.

In addition, Brukinsa recently received approval from the Singapore Health Sciences Authority for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

In Australia, more than 6,000 people are diagnosed with non-Hodgkin's lymphoma each year, making it the sixth most common cancer in adults. 

WM is a rare, slow-growing lymphoma that occurs in less than 2% of patients with NHL.

The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.

BeiGene has submitted for reimbursement of WM to the Pharmaceutical Benefits Advisory Committee. In a first for the PBAC, BeiGene expects to enter a facilitated resolution pathway in order to seek a listing date for the WM indication.

The Australian registration for Brukinsa in WM is based on efficacy results from the ASPEN clinical trial, a Phase 3 randomised, open-label, multicentre trial (NCT03053440) that evaluated Brukinsa compared to ibrutinib in patients with relapsed or refractory or treatment-naïve WM who harbor a MYD88 mutation (MYD88MUT).

In the ASPEN trial, Brukinsa demonstrated a numerically higher very good partial response rate (28.4%, 95% CI:20, 38) compared to ibrutinib (19.2%, 95% CI: 12, 28), although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met.

In the ASPEN trial, of the 101 patients with WM randomized and treated with Brukinsa, 5% of patients discontinued due to adverse events, including cardiomegaly, neutropenia, plasma cell myeloma, and subdural haemorrhage.

Adverse events leading to dose reduction occurred in 14.9% of patients, with the most common being neutropenia and diarrhea.

The overall safety profile of Brukinsa is based on pooled data from 779 patients with B-cell malignancies treated with Brukinsa in clinical trials.

The most common adverse reactions with Brukinsa were neutropenia, thrombocytopenia, upper respiratory tract infection, haemorrhage/haematoma, rash, bruising, anaemia, musculoskeletal pain, diarrhea, pneumonia, and cough.

The most common Grade 3 or higher adverse reactions were neutropenia, thrombocytopenia, pneumonia, and anaemia.

The recommended dose of Brukinsa is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

Brukinsa is a small molecule inhibitor of Bruton's tyrosine kinase discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Because new BTK is continuously synthesised, Brukinsa was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimising bioavailability, half-life, and selectivity.

With differentiated pharmacokinetics compared to other approved BTK inhibitors, Brukinsa has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

Brukinsa is approved in the United States, China, Australia, Canada, and other international markets in selected indications and under development for additional approvals globally.

BeiGene is committed to advancing hematology, immuno-oncology and targeted therapies in order to bring impactful and affordable medicines to patients across the globe.


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