MHRA authorises BRUKINSA^® in Great Britain for two cancers

Two marketing authorisations for BRUKINSA^® (zanubrutinib) have been granted in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). The indications are for adults with chronic lymphocytic leukaemia (CLL) and for adults with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

The MHRA’s authorisation is significant “… as there is no targeted treatment currently authorised for MZL patients other than chemoimmunotherapy,” explained Dr Renata Walewska, Department of Hematology, University Hospitals Dorset, Bournemouth, UK.

Clinical trials for chronic lymphocytic leukaemia and marginal zone lymphoma

The MHRA authorisation for CLL is based on two global Phase III clinical trials:

• SEQUOIA, comparing BRUKINSA^® against bendamustine plus rituximab (BR) in patients with previously untreated CLL
• ALPINE, comparing BRUKINSA^® against IMBRUVICA^® (ibrutinib) in patients with relapsed/refractory (R/R) CLL.

Dr Walewska shared: “BRUKINSA^® is a highly selective Bruton tyrosine kinase (BTK) inhibitor that has demonstrated clinically meaningful improvements over the first generation of BTK inhibitor in relapsed CLL.”

The small-molecule inhibitor is the only treatment authorised for MZL in Great Britain.

Clinical success begins early for small molecule drugs

The MHRA authorisation for MZL is based on results from the multicentre, global, single-arm, open-label, Phase II MAGNOLIA trial in patients with R/R MZL who received at least one anti-CD-20 based regimen.

“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,” commented Dr Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene.

Regulatory authorisations for BRUKINSA^®

BRUKINSA^® has received prior positive regulation decisions:

BRUKINSA^® is currently authorised in the European Union (EU), and Northern Ireland, for adults with WM who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemoimmunotherapy; for adults with CLL and for adults with MZL who have received at least one prior anti-CD20-based therapy.