BeiGene’s Brukinsa (zanubrutinib) has been approved by the European Commission (EC) for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukaemia (CLL).
The approval follows a recommendation made by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last month for the use of Brukinsa in this patient population.
The EC’s final decision is 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 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 Imbruvia in relapsed/refractory CLL, the company said, with an overall response rate of 80.4% versus 72.9%. Additionally, more Brukinsa patients than Imbruvica patients had a sustained response at one year, with rates of 90% versus 78%.
CLL is a slow-growing, life-threatening and incurable cancer and is one of the most common types of leukaemia, accounting for around one-quarter of new cases of leukaemia.
Mehrdad Mobasher, chief medical officer, Hematology at BeiGene, said: “This approval represents an important milestone for CLL patients and their physicians who now have a new chemotherapy-free treatment option, and an alternative to current BTK inhibitor treatment options.
“Given that Brukinsa has demonstrated consistent benefit across patient subgroups, regardless of risk status, we believe Brukinsa could now be the preferred treatment option for newly diagnosed and relapsed/refractory CLL patients.”
Brukinsa is currently approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemo-immunotherapy.
The company also received EC approval for Brunkinsa as a treatment for adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.