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BeiGene’s Brukinsa receives FDA approval for chronic lymphocytic leukaemia

The BTK inhibitor demonstrated better results than Imbruvica, a standard of care treatment in CLL


BeiGene’s Brukinsa (zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), the company announced.

The FDA’s decision was based on two global head-to-head phase 3 clinical trials in which Brukinsa – a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) – demonstrated superior efficacy against Janssen’s Imbruvica (ibrutinib) in patients with relapsed/refractory CLL or SLL, as well as against bendamustine plus rituximab in treatment-naïve CLL or SLL patients.

In the head-to-head ALPINE study against Imbruvica, Brukinsa achieved a superior overall response rate of 80.4% versus 72.9%, as well as superior progression-free survival (PFS). Significantly lower rates of atrial fibrillation/flutter were also observed in Brukinsa-treated patients, meaning the treatment has the potential to offer a more tolerable treatment option for certain patients.

“With four US approvals in just over three years and demonstrated superiority versus [Imbruvica] in the final PFS analysis of the ALPINE trial, we believe Brukinsa is well-positioned to become the BTKi of choice across multiple indications,” said Mehrdad Mobasher, chief medical officer, haematology at BeiGene.

CLL is the most common type of leukaemia, with around 3,800 people in the UK diagnosed with the disease each year. CLL and SLL are essentially the same diseases, treated in the same way, but are named depending on where most cancer cells are found. In CLL, malignant cells are concentrated in the blood and bone marrow, while in SLL they appear in the lymph nodes.

Brian Koffman, chief medical officer and executive vice-president at CLL Society, said: “Thanks to research that has delivered innovative and effective medicines, people with CLL can remain on therapy for years, so tolerability is an important consideration.

“I’m pleased that the approval of [Brukinsa] provides a new BTKi option for people with CLL/SLL, with demonstrated efficacy as well as being very well tolerated long-term.”

Brukinsa was most recently granted two new marketing authorisations by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of CLL, as well as for patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

The MHRA authorisation for MZL – a group of ultra-rare, slow growing B-cell malignancies – was based on results from the phase 2 MAGNOLIA trial in which Brukinsa achieved a high overall response rate of 68%, with 26% of R/R MZL patients achieving complete remission.

Article by
Emily Kimber

23rd January 2023

From: Regulatory



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