The U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five of its currently approved indications, expanding administration options for patients with B-cell malignancies while maintaining the same active ingredient, efficacy, and safety profile as the capsule formulation.
The newly approved 160 mg tablet is designed to simplify dosing by allowing patients to take two tablets daily instead of four 80 mg capsules, while keeping the recommended total daily dose at 320 mg. According to the company, the tablets are also smaller than the capsules and film-coated, which may help improve ease of administration for some patients receiving long-term therapy.
Approval of the tablet formulation was supported by two single-dose, open-label, randomized Phase 1 crossover studies in healthy adults that demonstrated bioequivalence between the tablet and capsule formulations. This means patients and healthcare providers can expect the tablet to deliver comparable exposure to zanubrutinib across all currently authorized uses.
The FDA decision reflects growing interest in more patient-friendly treatment options for chronic hematologic malignancies, where reducing pill burden and improving convenience can play an important role in long-term adherence. Among approved btk inhibitors, BRUKINSA continues to strengthen its position with expanded formulation options and flexible once- or twice-daily dosing.
BeOne Medicines also stated that the BRUKINSA tablet formulation replaced capsules, further supporting treatment flexibility for patients across all approved indications.
Overall, the approval marks another step forward in the evolution of targeted therapies for B-cell malignancies, reinforcing the role of BRUKINSA as one of the important treatment options in the landscape of approved btk inhibitors.
