[약업신문]Brukinsa Capsule, Applied Waldenstrom Rare Hematologic Cancer Microglobulinemia Reimbursement

Beigene Korea (CEO Yang Ji-hye) will reimburse ‘Brukinsa 80mg Capsule (Zanubrutinib)’ as a treatment for Waldenstrom’s macroglobulinemia from the 1st of next month in accordance with ‘Benefit List Amendment’ payments and Reimbursement of the Ministry of Health and Welfare. the Maximum Limit of Benefits’ 2. announced on the 28th that the

The reimbursement criteria for Brukinsa Capsule apply to monotherapy in adult patients with Waldenstrom’s macroglobulinemia who have previously received one or more treatments.

Brukinsa Capsule is a second generation BTK inhibitor that targets Bruton’s tyrosine kinase (BTK). Current patients with Waldenstrom’s macroglobulinemia were treated with chemotherapy that damages normal cells as well as cancer cells. Brukinsa Capsule is evaluated to have improved effects and side effects by targeting the BTK protein through the malignant B cell receptor (BCR).

In Korea, in addition to monotherapy in adult patients with Waldenstrom’s macroglobulinemia who have previously received one or more treatments, Brukinsa Capsule is used as monotherapy in adult patients with mantle cell lymphoma who have received one or more of previously treated monotherapy in adult patients. with relapsed/refractory marginal zone lymphoma who had received one or more prior therapies.

Waldenstrom’s macroglobulinemia is a rare form of non-Hodgkin’s lymphoma. It occurs mainly in the elderly, and the average age of diagnosis is known to be 70 years. The main pathogenesis is the infiltration of lymphoid plasma cells secreting monoclonal immunoglobulin M into the bone marrow.

Therefore, hyperviscosity syndrome can appear due to overproduction of immunoglobulin M. That is, blood viscosity increases due to an increase in immunoglobulin M, also known as macroglobulin, which has a very large molecular weight, and symptoms such as blood flow disorder, headache, nosebleeds, retinal hemorrhage, cerebral hemorrhage, and body numbness appeared. Anemia, thrombocytopenia, and neutropenia due to bone marrow involvement are also common. Some patients experience unexplained fever, night sweats or weight loss. For these characteristics, the Swedish doctor Waldenstrom first described this disease in 1944, and it is called Waldenstrom’s macroglobulinemia.

As a result of the phase 3 ASPEN study targeting patients with Waldenstrom’s macroglobulinemia, Brukinsa Capsule reduced the median immunoglobulin M level by 79%. In addition, the event free rate at 18 months for patients who achieved a complete response or a very good partial response was 93%. In a phase 1/2 study of patients with B-cell lymphoma, WM patients were treated for 3 years and demonstrated excellent long-term tolerability.

Professor Kim Seok-jin from the Department of Hematology and Oncology at Samsung Seoul Hospital said, “Waldenstrom’s macroglobulinemia has non-specific symptoms and there are diseases that need to be differentiated, so it is important to consult a specialist. Until recently, there was no effective treatment and few side effects among drugs covered by insurance, so it was considered a treatment wasteland.” for. The application of insurance benefits for Brukinsa Capsule this time is news like rain in a drought for domestic medical staff and patients. We hope that patients with Waldenstrom’s macroglobulinemia will be treated more actively with less financial burden.”

Yang Ji-hye, CEO of BeiGene Korea, said, “BeyGene is actively attracting clinical research of innovative new drugs to Korea to expand access to treatment. The insurance application of Brukinsa Capsule for Waldenstrom’s macrobulinemia may contribute to providing treatment options for rare and neglected cancer patients in Korea. We will do our best to develop and treat patients quickly.”