The National Institute for Health and Care Excellence (NICE) has recommended BeOne Medicines’ targeted cancer drug Brukinsa (zanubrutinib) to treat certain cases of mantle cell lymphoma (MCL).
The health technology assessment agency has recommended that the drug be used on the NHS in England and Wales as a treatment option for adults with relapsed or refractory MCL who have received at least one prior line of therapy.
Approximately 600 people are affected by MCL, a rare and aggressive form of non-Hodgkin lymphoma, every year in the UK. The disease originates from B cells, a type of white blood cell, and is associated with rapid progression.
Brukinsa is designed to block the action of the Bruton’s tyrosine kinase enzyme and help slow the progression of the disease. The drug is already recommended by NICE for a range of indications, including certain cases of Waldenstrom’s macroglobulinaemia, chronic lymphocytic leukaemia and marginal zone lymphoma.
Among the clinical evidence supporting NICE’s latest decision were results from the phase 2 BGB-3111-206 study, in which Brukinsa achieved an overall response rate (ORR) of 83.7% and a median duration of response (DoR) of 19.5 months.
Data from the phase 1/2 BGB-3111-AU-003 trial, in which the ORR was 84.4% and DoR was 18.5 months, also supported the recommendation.
Both studies highlighted Brukinsa’s effectiveness across various patient subgroups, including those with refractory disease and high-risk MCL International Prognostic Index scores, and the drug was generally well tolerated.
BeOne Medicine UK and Ireland’s general manager, Robert Mulrooney, said: “With [Brukinsa] now approved in more than 75 markets and more than 200,000 patients treated globally, we’re proud that patients in England and Wales can now benefit from access to this important treatment.
“We look forward to continuing to work with NICE, healthcare professionals and the patient community to help ensure timely access to innovative therapies that respond to the evolving needs of patients with B-cell malignancies in the UK.”
The Scottish Medicines Consortium is currently reviewing Brukinsa to treat MCL patients in Scotland.
