FDA Approves Tablet Form of BeOne's Cancer Drug Brukinsa

The US Food and Drug Administration (FDA) has granted approval for a new tablet formulation of BeOne Medicines' cancer drug, Brukinsa (zanubrutinib), aiming to simplify the treatment regimen for patients. Previously known as BeiGene, BeOne Medicines announced the FDA's authorization of the tablet version for all five indications that were covered by the original capsule formulation of this Bruton’s tyrosine kinase (BTK) inhibitor.

Brukinsa is utilized in treating specific cases of chronic lymphocytic leukemia or small lymphocytic lymphoma, Waldenström’s macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma. The transition from capsules to tablets is anticipated to offer patients a more straightforward dosing experience. Instead of four 80mg capsules, patients can take two 160mg tablets daily, simplifying their medication routine.

The newly approved tablets are expected to replace the capsule version starting October, and they are designed to be smaller and easier to swallow due to the addition of a film coating. This change is aimed at enhancing patient comfort during treatment. The FDA's approval of the tablet version was backed by positive outcomes from two phase 1 crossover studies involving healthy adults. These studies demonstrated that the tablet formulation maintains the same efficacy and safety profile as the capsule version.

Matt Shaulis, the general manager for North America at BeOne Medicines, emphasized the importance of this development, stating, "With this new tablet formulation, we are making treatment simpler and more convenient – an important step forward for patients facing certain B-cell cancers.” Meanwhile, the European Medicines Agency is in the process of reviewing an application for the tablet formulation of Brukinsa, with a decision anticipated later in the year.

This advancement comes slightly over a year after the FDA granted accelerated approval for Brukinsa's fifth indication, follicular lymphoma, which is the second most prevalent form of non-Hodgkin lymphoma. Brukinsa was approved for use in conjunction with Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) to treat relapsed or refractory follicular lymphoma in adults who have undergone at least two previous lines of systemic therapy.

The FDA's approval decision from March 2024 was also supported by positive results from the mid-stage ROSEWOOD study. This study demonstrated a 69% overall response rate for the combination treatment of Brukinsa and Gazyva, compared to a 46% response rate for Gazyva alone. Furthermore, the study highlighted an 18-month duration response rate of 69% for the Brukinsa combination treatment.

Overall, the new tablet formulation of Brukinsa represents a significant advancement for patients dealing with certain B-cell cancers, offering them a more convenient and simplified treatment option. As BeOne Medicines continues to expand access to innovative treatments, the approval of the tablet version marks a promising step in enhancing patient care.