BeiGene’s Brukinsa granted two new marketing authorisations by MHRA

BeiGene’s Brukinsa (zanubrutinib) has been granted two new marketing authorisations by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of chronic lymphocytic leukaemia (CLL) and for patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

The MHRA’s decision on CLL – one of the most common types of leukaemia – was based on two global head-to-head phase 3 clinical trials in which Brukinsa demonstrated superior efficacy against standard of care Imbruvica (ibrutinib) in patients with relapsed/refractory CLL, as well as superior efficacy against bendamustine plus rituximab in treatment-naïve CLL patients.

In the head-to-head study against Imbruvica, Brukinsa demonstrated significantly lower rates of atrial fibrillation/flutter, meaning the treatment has the potential to offer a more tolerable treatment option for certain patients.

The treatment is the only BTK inhibitor to achieve superiority versus Imbruvica in relapsed/refractory CLL, the company said, with an overall response rate of 80.4% versus 72.9%. Additionally, more Brukinsa patients than those treated with Imbruvica had a sustained response at one year, with rates of 90% versus 78%.

Mehrdad Mobasher, chief medical officer, Haematology at BeiGene said: “As a BTK inhibitor designed to maximise BTK occupancy and minimise off-target binding, we believe Brukinsa presents a very promising treatment option for eligible patients with MZL and CLL.”

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.

The treatment also delivered ‘rapid and durable’ disease control with a median time to response of 2.8 months, the company said, and was generally well-tolerated.

Dr Renata Walewska, Department of Haematology, University Hospitals Dorset said: “The authorisation of Brukinsa for MZL and CLL in Great Britain is a significant step forward for eligible patients and their physicians as there is no targeted treatment currently authorised for MZL patients other than chemoimmunotherapy, and it represents an alternative to current BTKi treatments for patients with CLL.”

The approvals follow the European Commission granting marketing authorisations for the use of Brukinsa in CLL and MZL in November 2022.

Brukinsa has also recently been recommended by the National Institute for Health and Care Excellence for the treatment of adult patients with Waldenström’s macroglobulinemia, a rare type of cancer that begins in the white blood cells.