FDA Approves Tablet Formulation of BeOne’s BRUKINSA® for All Approved Indications, Offering Greater Convenience for Patients with B-cell Cancers
BeOne Medicines Ltd. a global oncology-focused biopharmaceutical company, has received a significant regulatory milestone from the U.S. Food and Drug Administration (FDA). The agency has officially approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five of its previously approved indications. This decision represents a pivotal moment in the evolution of treatment convenience for patients with certain B-cell malignancies, while reinforcing BRUKINSA’s stronghold in the BTK inhibitor market.
With this latest approval, BRUKINSA becomes even more versatile in its administration, allowing patients and healthcare providers to benefit from a more user-friendly formulation. The newly approved tablet version provides a streamlined treatment option that maintains the same proven efficacy and safety profile as the original capsule form.
BRUKINSA’s Clinical and Market Leadership in BTK Inhibition
BRUKINSA, a Bruton’s tyrosine kinase (BTK) inhibitor developed by BeOne, has consistently demonstrated superiority in its therapeutic class through compelling clinical data and robust real-world adoption. It is currently approved in the United States for five indications, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL), among others.
Notably, BRUKINSA has emerged as the market leader in new CLL patient starts across all lines of therapy in the U.S. for the first time. According to internal data, BRUKINSA has surpassed its competitors to become the BTK inhibitor with the largest overall market share in the country. This achievement underscores the confidence that oncologists and hematologists place in its differentiated safety and efficacy profile.
Matt Shaulis, General Manager of North America at BeOne, emphasized the clinical and practical value of the new formulation:
“BRUKINSA’s leadership in the U.S. underscores the trust physicians and patients have placed in its differentiated clinical profile. With this new tablet formulation, we are making treatment simpler and more convenient—an important step forward for patients facing certain B-cell cancers.”
Establishing Bioequivalence and Safety of the Tablet Formulation
The FDA’s decision to approve the tablet formulation was supported by the findings of two single-dose, open-label, randomized Phase 1 crossover studies. Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form. The results confirmed that the new tablet formulation delivers the same clinical benefits as the capsules, ensuring continuity of care for patients transitioning between forms.
Importantly, BRUKINSA remains the only BTK inhibitor that offers flexible dosing options—either once-daily or twice-daily—based on patient needs and tolerability. Furthermore, it continues to be the only agent in its class with specific dose recommendations for patients with severe hepatic impairment, a key consideration for patients with underlying liver conditions or advanced-stage disease.
Enhancing Treatment Convenience: Smaller, Easier-to-Swallow Tablets
The newly approved BRUKINSA tablets are designed with patient comfort in mind. Each tablet contains 160 mg of zanubrutinib, meaning patients will now only need to take two tablets per day, as opposed to four of the previous 80 mg capsules. Additionally, the new tablets are physically smaller than the capsules and come with a film coating, which makes them easier to swallow—a practical but impactful improvement for patients who are often managing multiple medications and complex treatment regimens.
This change is expected to be especially beneficial for elderly patients or those with dysphagia (difficulty swallowing), who often find capsule medications challenging. By streamlining the administration process, BeOne aims to improve overall treatment adherence and patient satisfaction, both of which are crucial for successful long-term cancer management.
The rollout of the tablet formulation is expected to begin in October 2025, with BRUKINSA tablets replacing the current capsule offering in the U.S. market. BeOne has not indicated any changes to the pricing structure of the medication, but the company is actively working to ensure a smooth transition and supply continuity.
Regulatory Outlook in Europe
While the tablet formulation has secured approval in the United States, BeOne has also submitted a Type II variation marketing authorization application (MAA) to the European Medicines Agency (EMA). The application, which covers the same approved indications as the current BRUKINSA capsule formulation, is currently under review. Regulatory approval from the EMA is anticipated later in 2025, paving the way for expanded availability of the tablet version across European markets.
This move is in line with BeOne’s global commercialization strategy, which emphasizes product accessibility and regional adaptability. The ability to offer patients a choice between once- and twice-daily dosing, and now between capsules and tablets, allows physicians to tailor treatment plans more precisely to individual patient needs and preferences.
The Broader Implications for BTK Inhibitor Therapy
BTK inhibitors have become a cornerstone in the treatment of various B-cell malignancies, offering targeted therapy that disrupts cancer cell signaling and proliferation. However, treatment convenience and tolerability remain vital differentiators within this class of medications. BRUKINSA’s new tablet formulation not only affirms its leadership in clinical outcomes but also sets a new standard for patient-centric design in oncology therapeutics.
The competitive BTK inhibitor market includes other agents such as ibrutinib and acalabrutinib, each with its own clinical advantages and side-effect profiles. However, BRUKINSA’s continued innovation in formulation, alongside its strong efficacy data and tolerability, provides it with a distinct advantage. BeOne’s investment in lifecycle management and patient-oriented solutions reinforces its commitment to long-term leadership in this space.
As BeOne transitions BRUKINSA to its new tablet format, the company is also expected to focus on expanding the drug’s indications, developing next-generation BTK inhibitors, and pursuing combination therapies that could further enhance treatment outcomes for patients with hematologic cancers.
The FDA’s approval of the BRUKINSA tablet marks an important milestone in BeOne’s journey to make cancer care more personalized and patient-friendly. By integrating scientific innovation with practical considerations like pill size, dosing flexibility, and ease of swallowing, the company is reshaping the way targeted therapies are delivered and experienced by patients.
With its growing presence in the U.S. market, ongoing regulatory submissions in Europe, and a steadfast commitment to improving outcomes for patients with B-cell malignancies, BRUKINSA’s tablet launch is not just a product update—it is a reaffirmation of BeOne’s vision to elevate the standard of care in oncology.
