The US Food and Drug Administration (FDA) announced yesterday that a new tablet version of Brukinsa (zanubrutinib) has been FDA approved for all five indication types for which the medicine was previously authorized, while providing a simple and more efficient option of administration that keeps patients benefiting from the known high effectiveness and safety profile of the original capsule formulation of Brukinsa. BeOne Medicines is the manufacturer of the Bruton tyrosine kinase inhibitor drug. The indication of drug is to treat (i) adult patients with mantle cell lymphoma who are resistant (prior therapy), Waldenstrm’s macroglobulinemia, chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL); relapsed or refractory marginal zone lymphoma after one or more anti-CD20 based therapy, and relapsed or refractory follicular lymphoma in combination with obinutuzumab after two or more systemic therapies.
Out of five indications approved, three indications, namely, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma, are approved under an accelerated approval based on response rates, with continued approval potentially contingent on success of confirmatory trials. The newly developed 160 mg film-coated tablets are easy to swallow, making the medication intake more comfortable for patients. The prescribed dosage is twice 160 mg tablets or a single 320 mg tablet daily until disease progression or development of unacceptable toxicity. Now, patients will have just two tablets a day instead of four of the previous 80 mg capsules. Also, since the tablets are slightly smaller than the capsules, a film coating that is easier to swallow has been added. They are also functionally scored so that they can be divided if needed, but should not be crushed or chewed. For persons with significant or severe hepatic impairment Still the dosage should still be adjusted.
In mid-2025 at the latest, BeOne anticipates the tablet form to be the only one available here. BeOne stated further that their drug is the most commonly used BTK inhibitor in new patient treatment in CLL/SLL across treatment lines and has now also come ahead in the class in total on the US basis based on market share. The decision was based on findings from two phase 1 trials examining the cross-over bioequivalence of Brukinsa in healthy adults after which it was ascertained that both tablets and capsules deliver drug in approximately similar amounts. Because of this, patients can expect that by switching from the capsule format to the new, the therapeutic effects and safety can stay the same.
Executives stressed how life-saving this tablet would be to those diagnosed with B-cell lymphomas and leukemias. In Matt Shaulis own words This new format will make life easier for cancer patients. In 2019, zanubrutinib was the first in its class to be FDA approved for the treatment of mantle cell lymphoma, and since then, the product has gained new indications for Waldenstrm’s macroglobulinemia and marginal zone lymphoma.
Milestone approval decisions came in 2021 for these first two cancer types, in 2023 for chronic lymphocytic leukemia small lymphocytic lymphoma, and finally, in 2024, the approval for the lymphoma treatment with the combination regimens of obinutuzumab was achieved. There are currently more than 200,000 patients receiving Brukinsa worldwide, and the therapeutic is approved in at least the one indication in more than 75 countries.
By reducing the number of medicines a person needs to take each day and making the dosage process A lot easier without modifying the clinical outcome, the tablet form handles one of the typical problems faced in oral cancer chemotherapy. These patients often rely on such long-term or repeating pill treatments to manage the disease. A decrease in the pill count and an increase in the ease of getting the medicines swallowed would help maintain drug compliance and a better living condition without changing the flexibility of the single or double dosing pattern of Brukinsa that makes it stand out from BTK inhibitors available.