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CHMP Offers Positive Opinion for Zanubrutinib Tablet Formulation in B-Cell Malignancies

The EMA’s CHMP has recommended the approval of zanubrutinib tablets for B-cell malignancies.

Image Credit: © Bipul Kumar - stock.adobe.com

Image Credit: © Bipul Kumar - stock.adobe.com

The European Medicines’ Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of a tablet formulation of zanubrutinib (Brukinsa) for the treatment select patients with B-malignanices.1

If approved, the tablet formulation of zanubrutinib would be available in all currently approved indications for the reference drug. In the European Union, zanubrutinib is currently approved:2

  • For patients with Waldenström macroglobulinaemia who have not been treated before and who cannot receive chemo-immunotherapy, or in patients who have received at least 1 prior therapy.
  • For patients with marginal zone lymphoma (MZL) after at least 1 prior line of therapy containing an anti-CD20 agent.
  • For patients with chronic lymphocytic leukemia (CLL).
  • In combination obinutuzumab (Gazyva) for patients with follicular lymphoma after at least 2 prior therapies.

“The CHMP’s positive opinion of our new tablet formulation of [zanubrutinib] is an important step toward bringing this thoughtful, patient-centered innovation to people facing certain B-cell cancers across Europe,” Giancarlo Benelli, senior vice president and head of Europe at BeOne Medicines, stated in a news release.1 “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 recommendation was supported by data from a pair of phase 1 trials (NCT05767398 and NCT05547399), which evaluated the tablet formulation of zanubrutinib vs the capsule formulation in healthy adult participants. Findings showed that the tablet formulation was bioequivalent to the capsule form.

Mirroring the capsule formulation, the tablet formulation is recommended at a dose of 320 mg per day; however, the tablets are each 160 mg compared with the 80-mg capsules, allowing patients to take 2 tablets per day vs 4 capsules.

On June 11, 2025, the FDA approved the tablet formulation of zanubrutinib for use in all approved indications of the capsule formulation.3

In the United States, zanubrutinib indicated for adult patients with:4

  1. Mantle cell lymphoma (MCL) who have received at least 1 prior therapy.
  2. Waldenström macroglobulinemia
  3. relapsed or refractory MZL who have received at least 1 anti-CD20–based regimen.
  4. CLL or small lymphocytic lymphoma
  5. Relapsed or refractory follicular lymphoma, in combination with obinutuzumab, after two or more lines of systemic therapy.

In a news release for the positive CHMP opinion, BeOne Medicines—the developer of zanubrutinib—announced that it intends to convert the agent from capsules to tablets in regions outside of China in 2025 with the goal of reducing environmental impact via a smaller bottle size and being able to ship the agent with reduced temperature control.

Background of the Phase 1 Studies

Both phase 1 studies enrolled adult participants who were at least 18 years of age and no older than 65 years.5,6 They needed to have a body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, and they were required to be in good health.

During the study, participants were randomly assigned to receive a single dose of zanubrutinib as a capsule or a tablet. The study included a low-dose cohort and a high-dose cohort.

The studies’ primary end points were pharmacokinetics. Safety served as a secondary end point.

Zanubrutinib Safety Review

The most common adverse effects (AEs) associated with zanubrutinib comprise neutropenia, upper respiratory tract infection, hemorrhage, bruising, rash, and musculoskeletal pain.2 Serious AEs included neutropenia, pneumonia, hypertension, and thrombocytopenia.

References

  1. BeOne Medicines receives positive CHMP opinion for tablet formulation of Brukinsa. News release. BeOne Medicines. June 25, 2025. Accessed June 25, 2025. https://www.businesswire.com/news/home/20250623706166/en/BeOne-Medicines-Receives-Positive-CHMP-Opinion-for-Tablet-Formulation-of-BRUKINSA
  2. Brukinsa. European Medicines Agency. Updated May 8, 2025. Accessed June 25, 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/brukinsa
  3. U.S. FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications. News release. BeOne. June 11, 2025. Accessed June 25, 2025. https://www.businesswire.com/news/home/20250611860939/en/U.S.-FDA-Approves-Tablet-Formulation-of-BeOnes-BRUKINSA-for-All-Approved-Indications
  4. Brukinsa. Prescribing information. BeOne Medicines. Updated June 2025. Accessed June 25, 2025. https://beonemedicines.us/PDF/BRUKINSAUSPI.pdf
  5. Relative bioavailability of zanubrutinib tablets compared to capsules and effects of food on the pharmacokinetics of the tablet in healthy adults. ClinicalTrials.gov. Updated October 26, 2024. Accessed June 25, 2025. https://clinicaltrials.gov/study/NCT05547399
  6. Bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants. ClinicalTrials.gov. Updated October 26, 2024. Accessed June 25, 2025. https://clinicaltrials.gov/study/NCT05767398

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