BeiGene announces Brukinsa approved in Australia for treatment of patients with Mantle Cell Lymphoma.
On October 7, 2021, Brukinsa received its initial approval 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.
Following registration of Brukinsa with the Therapeutic Goods Administration (TGA) in both approved indications, these patients will have immediate access to Brukinsa through the BeiGene sponsored post-approval, pre-reimbursement access program.
“Mantle cell lymphoma is an uncommon form of non-Hodgkin lymphoma that is generally considered incurable. While the majority of patients respond well to their initial treatment, virtually all will develop progressive lymphoma over time. Existing therapies for patients with recurrent or refractory MCL are often ineffective or have side effects that can lead to treatment discontinuation,” said Professor Stephen Opat, Director of Clinical Haematology at Monash Health and a principal investigator in the zanubrutinib clinical program. “I’m encouraged that zanubrutinib – a highly selective BTK inhibitor with promising clinical results from two trials in relapsed or refractory MCL – will provide a new treatment option for these patients living in Australia.”
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