BeiGene Korea said on Tuesday that its Bruton's tyrosine kinase (BTK) inhibitor, Brukinsa 80 mg capsules (ingredient: zanubrutinib), recently obtained approval for the treatment of adult chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

This approval adds to Brukinsa’s previous indication to treat adult patients with Waldenstrom Macroglobulinemia (WM) or recurrent/unresponsive marginal zone lymphoma (MZL) who have previously received one or more treatments and adult patients with mantle cell lymphoma (MCL). It also won reimbursement coverage for WM in May.

CLL and SLL, slow-growing, life-threatening, and incurable adult cancer, are mature B-cell malignancies in which abnormal B lymphocytes arise from the bone marrow and flood peripheral blood and lymphoid tissues. 

Approximately 190 patients in Korea have been diagnosed, and it is characterized by a slow progression over months to years and repetition of recurrence and remission.

Brukinsa is being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

The capsule was approved as a monotherapy for adult patients 65 years and older with naïve CLL or SLL or adult patients below 65 years of age with co-morbidities and with CLL or SLL, previously treated with at least one previous treatment.

Brukinsa won the U.S. FDA approval as a treatment for CLL or SLL in January. 

In the European Commission (EC), it was permitted as a treatment for CLL in November 2022.

In March this year, it was approved by the Australia Therapeutic Goods Administration (TGA).

The Korean approval was granted based on two phase 3 trials SEQUOIA, and ALPINE, which both demonstrated Brukinsa to be efficacious and well-tolerated in CLL/SLL patients.

The SEQUOIA trial is a global phase 3 clinical study comparing bendamustine and rituximab to zanubrutinib in CLL and SLL patients who have never been treated before. Consequently, the study confirmed a superior progression-free survival (PFS) rate at 24 months of 85.5 percent in the zabrutinib arm compared to 69.5 percent in the comparative arm and also a reduced risk of disease progression or death compared to the bendamustine+rituximab patient group.

The ALPINE trial is a global phase 3 clinical study comparing zanubrutinib versus ibrutinib, in patients with recurrent refractory CLL or SLL. Accordingly, zanubrutinib demonstrated a higher overall response rate (ORR)  of 83.5 percent compared to 74.2 percent in ibrutinib. Again, the PFS was also comparatively higher at 24 months with a greater reduction in risk of disease or death.  

The most common adverse reactions reported in the two clinical studies include neutropenia, thrombocytopenia, upper respiratory tract infection, bruising, hemorrhage, rash, anemia, and musculoskeletal pain, which were generally identified between mild and severe.

“Brukinsa has already proven its effectiveness and tolerance as a next-generation BTK treatment option and can now present better treatments for patients with chronic lymphocytic leukemia, one of the most common types of adult leukemia, along with flexible medication options,” said Professor Kim Seok-jin of Hematology and Oncology at Samsung Medical Center (SMC).

Two other BTK inhibitors have also been approved in Korea including AstraZeneca's calquence (ingredient: acalabrutinib) and Velexbru (ingredient: tirabrutinib hydrochloride.

However,  Janssen's Imbruvica (ingredient: ibrutinib) has been the only BTK inhibitor in Korea approved for treating CLL and SLL indications. It won health insurance coverage in April 2018.