BeOne Medicines Receives Positive CHMP Opinion for New Film-Coated Tablet Formulation of BRUKINSA® (zanubrutinib), Paving the Way for European Market Approval
BeOne Medicines Ltd. a globally operating oncology-focused biopharmaceutical company, has taken a significant step forward in expanding patient access to its BTK inhibitor BRUKINSA® (zanubrutinib) across Europe. The company announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory body of the European Medicines Agency (EMA), has issued a positive opinion recommending approval of a new tablet formulation of BRUKINSA for all currently approved indications.
This positive recommendation marks an important regulatory milestone. The CHMP’s opinion will now be forwarded to the European Commission (EC), which is responsible for granting centralized marketing authorization in the European Union (EU), as well as in the European Economic Area (EEA) countries Norway and Iceland. A final decision from the EC is expected in the coming months and, if approved, would enable BeOne Medicines to offer the new tablet version of BRUKINSA across the EU and EEA, further enhancing the drug’s accessibility and convenience for patients battling B-cell malignancies.
A Patient-Centered Innovation in B-Cell Cancer Treatment
Zanubrutinib, marketed as BRUKINSA, is a next-generation Bruton’s tyrosine kinase (BTK) inhibitor approved for the treatment of various B-cell malignancies. The newly developed tablet formulation is a film-coated version that has been carefully designed to improve patient experience while maintaining the efficacy and safety profile established by the original capsule form.
“The CHMP’s positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to people facing certain B-cell cancers across Europe,” stated Giancarlo Benelli, Senior Vice President and Head of Europe at BeOne Medicines. “We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.”
The tablet formulation is intended to provide increased dosing flexibility and improved patient adherence. It comes in 160 mg tablets, allowing patients to take two tablets daily to meet the recommended 320 mg total daily dose—either once or twice daily as per clinical discretion. This streamlined regimen reduces the daily pill burden compared to the capsule version and offers a more user-friendly experience, particularly for patients who may face challenges swallowing larger pills.
Clinical Evidence Supporting Tablet Formulation
The positive CHMP opinion was based on data from two single-dose, open-label, randomized Phase 1 crossover studies conducted in healthy volunteers. These studies demonstrated that the BRUKINSA tablet formulation is bioequivalent to the existing capsule form, confirming that patients switching between formulations can expect comparable pharmacokinetics and clinical outcomes.
Importantly, the smaller size of the tablets, coupled with their film coating, is designed to make them easier to swallow than the current capsules—a meaningful benefit for patients on long-term therapy. Additionally, the tablet form supports flexible dosing and simplifies dose reductions, which may be required due to drug interactions or adverse events, as guided by the product’s label.
Global Transition to Tablets Beginning in 2025
BeOne Medicines has outlined a global strategy to transition from the capsule form to the new tablet formulation of BRUKINSA outside of China beginning in 2025. This initiative is part of the company’s broader sustainability efforts aimed at reducing its environmental impact and improving supply chain efficiency.
By moving to tablets, BeOne estimates a reduction in bottle size by approximately 70%, which not only decreases plastic use but also facilitates more efficient packaging and transportation. The tablet formulation also enables reduced temperature control requirements during shipping and storage, further decreasing energy consumption, greenhouse gas emissions, and overall logistical costs.
These sustainability considerations align with growing global demand for environmentally responsible pharmaceutical manufacturing and distribution. BeOne Medicines’ decision to incorporate these factors into the BRUKINSA product lifecycle reflects the company’s commitment to corporate responsibility and long-term operational resilience.
Alignment with U.S. Regulatory Developments
The CHMP’s favorable opinion in Europe follows a similar regulatory milestone in the United States. Earlier this month, the U.S. Food and Drug Administration (FDA) granted approval to the tablet formulation of BRUKINSA for all five of its approved indications. This dual regulatory progress signals strong global confidence in the new formulation and sets the stage for expanded availability in key markets.
In the United States, BRUKINSA has continued to demonstrate its clinical and commercial strength. It currently leads in new patient starts for chronic lymphocytic leukemia (CLL) across all lines of therapy and, for the first time, has emerged as the market share leader among BTK inhibitors overall. This market momentum, combined with the newly approved tablet form, positions BRUKINSA as a best-in-class option for patients and providers alike.
Background on BRUKINSA and BTK Inhibition
BRUKINSA (zanubrutinib) is an oral, selective, and irreversible inhibitor of Bruton’s tyrosine kinase, an enzyme involved in B-cell receptor signaling and the pathogenesis of various B-cell malignancies. It has demonstrated high selectivity and minimal off-target activity, contributing to its favorable safety and efficacy profile in clinical trials.
BRUKINSA is approved in multiple global markets for the treatment of several hematologic cancers, including:
- Chronic lymphocytic leukemia (CLL)
- Waldenström’s macroglobulinemia (WM)
- Mantle cell lymphoma (MCL)
- Marginal zone lymphoma (MZL)
The new tablet formulation does not alter the approved indications, dosage, or safety profile of the drug. Instead, it offers patients an enhanced administration option, which can support better long-term adherence and overall treatment satisfaction.
As BeOne Medicines awaits the final decision from the European Commission, the company is laying the groundwork for a smooth commercial rollout of the tablet formulation across Europe. Preparations include updates to packaging, logistics planning, education for healthcare professionals, and outreach to payers and regulators to ensure that patients can access the new formulation as seamlessly as possible once approved.
The shift to a tablet form also presents opportunities to optimize health system efficiencies, particularly in regions where simplified dosing regimens and improved drug stability can reduce administrative burdens and enhance the patient care experience.
The positive CHMP opinion for BRUKINSA’s tablet formulation represents a pivotal step in BeOne Medicines’ ongoing efforts to innovate for patients with B-cell malignancies. By offering a more convenient, sustainable, and patient-friendly version of its BTK inhibitor, the company is addressing real-world challenges in cancer care while reinforcing its leadership position in hematologic oncology.
As approval from the European Commission is anticipated later this year, BeOne Medicines is poised to deliver on its mission to improve patient outcomes through science-driven, practical innovation. With successful launches already underway in the U.S. and a global transition strategy in motion, the tablet formulation of BRUKINSA stands to make a significant impact on how BTK inhibitor therapy is delivered around the world.
