The FDA’s decision was 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 Janssen’s Imbruvica (ibrutinib) in patients with relapsed/refractory CLL or SLL, as well as against bendamustine plus rituximab in treatment-naïve CLL or SLL patients.
In the head-to-head ALPINE study against Imbruvica, Brukinsa achieved a superior overall response rate of 80.4% versus 72.9%, as well as superior progression-free survival (PFS). Significantly lower rates of atrial fibrillation/flutter were also observed in Brukinsa-treated patients, meaning the treatment has the potential to offer a more tolerable treatment option for certain patients.
