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