FDA Approves Brukinsa for Chronic Lymphocytic Leukemia

This is the fourth indication for the Bruton’s tyrosine kinase inhibitor.

The FDA has approved Brukinsa (zanubrutinib) to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Developed by BeiGene, Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK). BTK is an important enzyme in the B-cell receptor signaling pathway, regulating cell proliferation and cell survival in various B cell malignancies, including chronic lymphocytic leukemia.

Chronic lymphocytic leukemia is a slow growing type of B-cell malignancy, classified by overgrowth of white blood cells in the bone marrow. It is the most common leukemia in adults. It typically affects older white men with a median age at diagnosis of 70. In the United States, there will be an estimated 4,410 death this year due to chronic lymphocytic leukemia.

Brukinsa has a 30-day wholesale acquisition cost of $14,487. A company spokesperson said a patient support program can answer questions about treatment and provide insurance coverage assistance.

“We have seen striking data from the Brukinsa development program demonstrating significant and consistent efficacy across CLL patient sub-types, including the high-risk del17p/TP53 mutated population, and regardless of treatment setting,” Jennifer R. Brown, M.D., Ph.D., director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, said in a press release. “With extensive follow-up across the CLL development program and the combined results from the SEQUOIA and ALPINE trials, Brukinsa is established as a new standard of care for CLL.”

The approval is based on two global phase 3 clinical trials. With a median follow-up of 26.2 months in the SEQUOIA trial, Brukinsa demonstrated a progression free survival benefit versus bendamustine plus rituximab in the first-line treatment setting. In the ALPINE trial, it achieved an overall response rate of 80.4% compared with 72.9% for Imbruvica (ibrutinib) in the relapsed/refractory (R/R) treatment setting. Data from this trial was published in December 2022 in the New England Journal of Medicine.

The overall safety profile in the ALPINE and SEQUOIA trials was consistent with prior studies. In the pooled safety population of 1,550 CLL patients, the most common adverse reactions were decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, and musculoskeletal pain. Brukinsa also demonstrated a favorable cardiac safety profile compared with Imbruvica, with lower rates of atrial fibrillation/flutter and no deaths due to cardiac disorders.

Brukinsa is approved for three other indications in the United States: to treat adults with mantle cell lymphoma (November 2019); to treat of adult patients with Waldenström’s macroglobulinemia (August 2021); and to treat adult patients with relapsed or refractory marginal zone lymphoma (September 2021).