The US FDA approval of Brukinsa was based on results from the Phase 3 ASPEN trial, which evaluated Brukinsa compared to ibrutinib, in a total of 201 patients with Waldenström’s macroglobulinemia

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US FDA approves Brukinsa for the treatment of WM. (Credit: BeiGene, Ltd.)

Chinese biotechnology firm BeiGene has received the US Food and Drug Administration (FDA) approval for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM).

WM is a rare type of cancer that affects certain types of B lymphocytes and is characterised by elevated levels of a circulating antibody, immunoglobulin M (IgM)

The disease is known as ‘indolent lymphoma’, which refers to cancer that grows and spreads slowly, and shares clinical characteristics with the indolent non-Hodgkin lymphomas.

Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) protein, specifically designed to deliver optimised bioavailability, half-life, and selectivity.

The drug is currently being evaluated worldwide, as a monotherapy and in combination with other therapies to treat several types of B-cell malignancies.

Brukinsa is said to inhibit the malignant B cells proliferation in different disease-related tissues, due to its differentiated pharmacokinetics than other approved BTK inhibitors.

The company has submitted more than 30 marketing authorisation applications in multiple indications, in the US, China, the European Union, and more than 20 other countries.

The latest approval represents the second FDA approval for Brukinsa also marks the world’s third approval in WM indication.

BeiGene haematology chief medical officer Jane Huang said: “We are delighted by today’s FDA approval for Brukinsa in its second indication, offering a new treatment option with demonstrated efficacy and safety benefits for patients with Waldenström’s macroglobulinemia.

“With 11 regulatory approvals in under two years, including two in the US, Brukinsa is demonstrating its growing utility as a treatment option for B-cell malignancies and expanding its footprint to potentially benefit more patients worldwide.

“We will continue to evaluate Brukinsa in its broad global clinical program and look forward to additional clinical evidence to establish its position as a potentially best-in-class medicine.”

The US FDA approval of Brukinsa was based on results from Phase 3 ASPEN trial.

The multicentre, open-label trial evaluated Brukinsa compared to ibrutinib, in a total of 201 patients with WM.

In the study, a very good partial response (VGPR) rate in the overall intention-to-treat (ITT) population as assessed by the independent review committee (IRC) was the primary efficacy endpoint.

In the FDA-approved label, the major efficacy outcome is defined as the response rate of partial response (PR) or better as assessed by IRC.

The treatment with Brukinsa demonstrated a 28% VGPR rate, compared to 19% with ibrutinib, based on the modified IWWM-6 response criteria.

Furthermore, Brukinsa resulted in a response rate of 78%, compared to 78% with ibrutinib, and the event-free duration of response (DoR) of 94%, compared to 88% with ibrutinib.

Earlier this year, BeiGene has collaborated with Novartis to jointly develop, manufacture and commercialise its cancer drug tislelizumab in the markets outside of China.