Instant Report

Date: 08-Oct-2021

BeiGene Announces First Regulatory Approval In Australia For BRUKINSA® Zanubrutinib For Treatment Of Patients With Waldenstroms Macroglobulinemia

Represents BRUKINSA’s Second Recent Approval in the Asia-Pacific Region, Following October 1 Approval in Singapore for Treatment of Patients with Mantle Cell Lymphoma

The TGA approval is based on results from ASPEN, an Australia-inclusive head-to-head clinical trial evaluating BRUKINSA compared to ibrutinib in patients with Waldenström’s macroglobulinemia


CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)-- BeiGene Co.,Ltd (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that BRUKINSA® (zanubrutinib) has been approved in Australia for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy.1 Following registration of BRUKINSA with the Australia Therapeutic Goods Administration (TGA), 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 (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

“BTK inhibition is an established mode of treatment for patients with WM, and the ASPEN trial showed that BRUKINSA is highly effective and has improved tolerability compared to the first-generation BTK inhibitor,” said Professor Con Tam, MBBS, M.D., Disease Group Lead for Low Grade Lymphoma and Chronic Lymphocytic Leukemia at the Peter MacCallum Cancer Centre and a principal investigator on the BRUKINSA clinical program. “BeiGene first began clinical trials of BRUKINSA in Australia in 2013, and since that time, many Australians have benefitted from treatment as part of ongoing clinical studies. We hope this therapy will offer new hope for people living with WM in Australia.”

In Australia, more than 6,000 people are diagnosed with non-Hodgkin’s lymphoma (NHL) each year, making it the sixth most common cancer in adults.WM is a rare, slow-growing lymphoma that occurs in less than two percent of patients with NHL.3 The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.3

“While WM is a slow-growing lymphoma, not all patients fully respond to existing therapies and many discontinue treatment due to side effects,” commented David Young, the National Team Leader at the WMozzies. “We are pleased to hear that people living with WM in Australia will have immediate access to this next-generation BTK inhibitor that has demonstrated clinical benefit with potential to improve treatment outcomes.”

BeiGene has submitted for reimbursement of WM to the Australia Pharmaceutical Benefits Advisory Committee (PBAC). 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.

“BRUKINSA has been shown to induce deep and durable responses with reduced off-target side effects, suggesting improved clinical benefit compared to standard BTK inhibitor therapy,” said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. “We are grateful to the Australian investigators, patients and families who participated in clinical trials contributing to TGA approval. Our ability to offer BRUKINSA to people in Australia impacted by WM is another step toward fulfilling our goal of increasing affordable access to oncology medicines around the world