FDA approves Brukinsa tablet for CLL, certain B-cell lymphomas
Beone calls new formulation 'simpler and more convenient' for patients
The U.S. Food and Drug Administration (FDA) has approved a tablet formulation of Beone Medicines’ Brukinsa (zanubrutinib) — previously marketed by the developer in capsule form — for several types of blood cancer that affect immune B-cells, such as chronic lymphocytic leukemia (CLL) and certain lymphomas.
“With this new tablet formulation, we are making treatment simpler and more convenient — an important step forward for patients facing certain B-cell cancers,” Matt Shaulis, general manager of North America at Beone, said in a company press release.
The tablet will replace the currently approved Brukinsa capsules starting in October, according to Beone. With its film coating, the tablets should be easier for individuals on the cancer therapy to swallow, the company stated.
Further, each tablet is 160 mg, so most users will require two to meet the recommended daily dosage, rather than four of the current 80 mg capsules, per the developer.
In two now-completed Phase 1 clinical trials (NCT05547399, NCT05767398), the tablet formulation was found to be biologically equivalent to the capsules. Supported by these findings, the new FDA approvals cover the same indications as the capsules, according to Beone.
Brukinsa increased progression-free survival in trials
In addition to CLL, the therapy may be used for individuals with small lymphocytic lymphoma, known as SLL, and Waldenström’s macroglobulinemia, or WM. People with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) who have received at least one prior treatment — including an anti-CD20 therapy in the case of MZL — may use Brukinsa under an accelerated approval from the FDA, the company stated, noting that such approval may be contingent on the results of confirmatory clinical trials.
Also under an accelerated approval, people with relapsed or refractory follicular lymphoma (FL) who have already received two previous systemic therapies can use Brukinsa alongside Gazyva (obinutuzumab).
These blood cancers all involve B-cells, a type of immune cell that produces antibodies to help the body fight off infections. In CLL, cancerous B-cells grow out of control in the bone marrow, the spongy tissue inside some bones where blood cells are produced. Eventually, these malignant cells spread through the body in the bloodstream.
To counteract B-cell growth, Brukinsa inhibits a protein called Bruton’s tyrosine kinase (BTK) found on most B-cells. This interferes with signaling pathways that support B-cell survival, growth, and activation. In clinical trials, Brukinsa increased length of survival without disease progression, also called progression-free survival.
Brukinsa is the only BTK-targeting therapy with the flexibility to be taken either once or twice daily, according to Beone, which noted that the medication has a distinct clinical profile compared with other similar treatments.
According to the company, the “new formulation provides patients with a simplified dosing experience — reducing pill burden and enhancing ease of administration — while preserving flexible dosing options.”
In the European Union, regulators are now reviewing the tablet formulation of Brukinsa. The company said it expects a decision about marketing approval later this year. As of now, people in the EU with CLL, WM, MZL, and FL can take Brukinsa, the company said.
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