FDA Approves Brukinsa Tablet For Various Blood Cancers

FDA approves new Brukinsa tablet for five blood cancers: © stock.adobe.com.

The U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Brukinsa (zanubrutinib) for all five of its approved indications, according to a news release from BeOne Medicines Ltd.

These indications include chronic lymphocytic leukemia or small lymphocytic lymphoma, Waldenström’s macroglobulinemia, mantle cell lymphoma for patients who have received at least one prior therapy, relapsed or refractory marginal zone lymphoma for those who have undergone at least one anti-CD20-based regimen, and relapsed or refractory follicular lymphoma in combination with Gazyva (Obinutuzumab) after two or more lines of systemic therapy.

“Brukinsa’s leadership in the U.S. underscores the trust physicians and patients have placed in its differentiated clinical profile,” Matt Shaulis, general manager of North America, BeOne, said in the news release. “With this new tablet formulation, we are making treatment simpler and more convenient — an important step forward for patients facing certain B-cell cancers.”

Brukinsa’s daily dose remains 320 milligrams (mg) but will now be given as two 160 mg tablets instead of four 80 mg capsules. These smaller, film-coated tablets improve swallowing and will replace capsules in October 2025.

Brukinsa tablets have the same effectiveness and safety as the capsules, according to two phase 1 studies in healthy adults that confirmed bioequivalence. Brukinsa is the only BTK inhibitor that offers flexible once- or twice-daily dosing to fit patient needs. It also remains the only BTK inhibitor with recommended dosing for patients with severe liver impairment.

The European Medicines Agency is currently reviewing a type 2 variation marketing authorization application, or MAA, for the new tablet formulation of Brukinsa across all approved uses. An MAA is a formal request to authorize a medicine for sale in Europe. Approval is expected later this year.

What is Brukinsa?

Brukinsa is a pill that blocks a protein called Bruton’s tyrosine kinase, or BTK, which helps certain cancer cells grow. By targeting BTK, Brukinsa stops the growth of malignant B cells, which are involved in several blood cancers. It is designed to work efficiently in the body with improved absorption, longer activity, and high precision.

Unlike other BTK blockers, Brukinsa offers flexible dosing options, allowing patients to take it once or twice daily based on their needs. It is also the only BTK inhibitor proven to be more effective than another BTK inhibitor in a major clinical study.

Worldwide, Brukinsa has been tested in over 7,000 patients across 35 clinical trials and is approved for use in more than 75 countries. More than 200,000 patients have received treatment with Brukinsa globally.

Safety and Side Effects of Brukinsa

The most common side effects in 1,729 patients receiving Brukinsa were decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%) and musculoskeletal pain (31%), according to the news release.

Additionally, Brukinsa may cause serious bleeding, including fatal cases, in some patients. Infections, including severe and opportunistic types, are common and should be monitored closely. Low blood counts such as neutropenia, and thrombocytopenia frequently occur and may require treatment adjustments.

Heart rhythm problems, including atrial fibrillation, have been reported. Liver injury can be severe; regular liver function tests are recommended. There is a risk of developing second cancers, especially non-melanoma skin cancers, so sun protection and monitoring are advised. Brukinsa can harm a developing fetus; pregnancy should be avoided during treatment and for one week after.

Patients need close monitoring and management throughout treatment.

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