FDA Approves Brukinsa for Two Leukemia Types

The Food and Drug Administration (FDA) approved Brukinsa (zanubrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), according to the agency.

The FDA approval was based off two clinical trials: SEQUOIA and ALPINE.

Researchers conducting the SEQUOIA clinical trial compared outcomes in 479 patients with previously untreated CLL or SLL — including those without a 17p deletion. Half the patients received Brukinsa while the other half received bendamustine plus Rituxan (rituximab).

Researchers were intent on seeing if Brukinsa led to a better progression-free survival (time from treatment until disease worsens or spreads) than the two-drug regimen, which is what occurred. The average progression-free survival was not evaluable in the Brukinsa group, meaning that half of the patients in the group lived longer than estimated by researchers, whereas it was 33.7 months in the bendamustine/Rituxan group.

In a separate part of the SEQUOIA trial, Brukinsa was evaluated in 110 patients with untreated CLL/SLL that harbored the 17p deletion. Eight-eight percent of patients in this group responded to therapy. In addition, at an average follow-up of 25.1 months, the average duration of response was not met.

Efficacy for patients with relapsed or refractory (did not respond or stopped responding to treatment) disease was studied in the ALPINE clinical trial, which involved 652 patients who were randomly assigned to receive either Brukinsa or Imbruvica (ibrutinib).

On average, patients enrolled in the ALPINE trial were treated with at least one prior therapy, though the number ranged from one to eight.

The ALPINE trial’s main goal was to assess overall response rate (percentage of patients whose disease improves from treatment), as well as duration of response. Overall, 80% of patients responded to Brukinsa compared with 73% for Imbruvica. At an average follow-up of 14.1 months, average duration of response was not yet met for either group.

READ MORE: Survival and Treatment Response May Be Further Improved With Brukinsa Versus Imbruvica for CLL/SLL

Across both trials, the most common side effects that occurred in at least 30% of patients were decreases in neutrophil count (42%), upper respiratory tract infection (39%), decreases in platelet count (34%), bleeding (30%) and musculoskeletal pain (30%).

Second diseases, including non-skin carcinomas, developed in 13% of patients. Atrial fibrillation or flutter (heart rhythm irregularities) were reported in 3.7% of patients, and severe or worse ventricular arrhythmias (when lower chambers of the heart twitch instead of pump) in 0.2% of patients.

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