BeiGene’s Brukinsa (zanubrutinib) has been recommended for conditional marketing authorisation (CMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the company announced.
The recommendation 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.
Moreover, 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.
“BTK inhibitors have proven to be highly effective oral treatments for CLL; however, the burden of adverse events and discontinuations have a negative impact on patients’ prognosis,” said Professor Clemens Wendtner, head of hematology and oncology at Munich Clinic, an academic teaching hospital of the University of Munich.
“The findings from two large head-to-head phase 3 trials of Brukinsa in CLL demonstrated efficacy across lines of therapy in addition to consistently low rates of atrial fibrillation/flutter and discontinuation across trials. This clinical trial data suggests Brukinsa has the potential to become a practice-changing treatment option for CLL,” he added.
CLL is a slow-growing, life-threatening and incurable cancer of adults and is one of the most common types of leukaemia, accounting for approximately one-quarter of new cases of leukaemia.
Following the positive opinion, the European Commission will consider BeiGene’s Marketing Application, with a final decision expected within 67 days of receipt of the CHMP’s recommendation. This decision will be applicable to all 27 member states of the EU, plus Iceland and Norway.
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. Additionally, the CHMP has also recently recommended the approval of Brukinsa for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.
“We are proud of the rapid progress we have made over the past year bringing Brukinsa to the blood cancer community in Europe,” said Gerwin Winter, senior vice president, head of Europe at BeiGene. “With this recommendation, we are looking forward to the opportunity to provide this important medicine to more people with haematologic malignancies in the EU.”