The US Food and Drug Administration (FDA) has granted approval to a tablet formulation of BeOne Medicines’ targeted cancer drug Brukinsa (zanubrutinib).
The company formerly known as BeiGene announced that the new formulation has been authorised for all five indications covered by the original capsule version of its Bruton’s tyrosine kinase (BTK) inhibitor.
This includes certain cases of chronic lymphocytic leukaemia or small lymphocytic lymphoma, Waldenström’s macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma.
It is hoped that the new formulation will offer a simplified dosing experience, with patients able to take two 160mg tablets a day rather than four of the current 80mg capsules.
The Brukinsa tablets, which are expected to replace Brukinsa capsules from October this year, are also smaller and have a film coating, making them easier to swallow.
The FDA’s latest decision on the drug was supported by positive results from two phase 1 crossover studies of healthy adults, which demonstrated that Brukinsa tablets have the same efficacy and safety as Brukinsa capsules.
Matt Shaulis, general manager of North America, BeOne, said: “With this new tablet formulation, we are making treatment simpler and more convenient – an important step forward for patients facing certain B-cell cancers.”
The European Medicines Agency is currently reviewing an application for the new tablet formulation of Brukinsa, with a decision expected later this year.
The authorisation comes just over a year after the FDA granted accelerated approval to Brukinsa for its fifth indication, follicular lymphoma, the second most common type of non-Hodgkin lymphoma.
The drug was approved for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) to treat relapsed or refractory follicular lymphoma in adults who have received at least two prior lines of systemic therapy.
The FDA’s March 2024 decision was supported by positive results from the mid-stage ROSEWOOD study, which demonstrated an overall response rate of 69% for the Brukinsa combination arm compared to 46% for Gazyva alone. An 18-month duration of response of 69% for the Brukinsa combination was also observed.