BeiGene’s Brukinsa approved for treatment of patients with mantle cell lymphoma

BeiGene’s Brukinsa (zanubrutinib) has been approved in Australia for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This follows on from its recent 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.

“Australia has some of the highest rates of non-Hodgkin’s lymphoma in the world, and these patients need options for treatment beyond those that exist today,” said Sharon Winton, CEO of Lymphoma Australia.

“MCL patients will certainly welcome the news that BeiGene is providing access to Brukinsa by sponsoring a pre-reimbursement program, as new therapies are critical, especially to those diagnosed later in life when it may be challenging to tolerate more aggressive types of treatment.”

The Australian registration for Brukinsa in MCL is based on efficacy results from two single-arm clinical trials.

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