Several weeks ago, the Food and Drug Administration approved Zanubrutinib (Brukinsa) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Brukinsa is a type of targeted therapy. It works by blocking the uncontrolled growth of cancer cells and so helps to stop their spread.

The approval was based on results from two different clinical trials which evaluated the efficacy of Brukinsa among CLL patients, at different stages and with different characteristics of the disease, as opposed to different kinds of standard treatments.

Efficacy was also evaluated among high-risk CLL patients with unfavorable disease features.

In each trial patients were randomly assigned to receive either Brukinsa (study group), or standard treatment (control group).

The follow-up period differed between the trials, ranging from over a year to about three years.

At the end of the follow-up period, Brukinsa demonstrated a significant and consistent efficacy among all CLL patient subtypes with an impressive response rate. Also, a significantly lower risk of disease progression has been observed among the study group patients receiving Brukinsa, compared to those receiving standard treatments (control group).

The most common side effects reported were decreased white blood count and thrombocytes, upper respiratory tract infection and musculoskeletal pain.

The researchers believe that Brukinsa provides a new option for patients with CLL/SLL, with demonstrated efficacy, as well as being very well tolerated long-term.