BeiGene's Zanubrutinib Approved in Switzerland for the Treatment of Waldenström's Macroglobulinemia

Recently, BeiGene announced that its BTK inhibitor Brukinsa (Chinese trade name: Baiyueze®, generic name: zanubrutinib, zanubrutinib) has been approved by Swissmedic: for the treatment of Adult patients with Waldenström macroglobulinemia (WM)

In China, Brukinsa (Baiyueze®) was approved by the National Medical Products Administration (NMPA) in June 2021 for the treatment of adult patients with relapsed or refractory WM

The Swiss approval is based on data from the global head-to-head Phase 3 ASPEN trial

ASPEN is a randomized, open-label, multicenter Phase 3 clinical trial (NCT03053440) in patients with relapsed or refractory (R/R) WM and previously treatment-naive (treatment-naive) WM.

Results: According to the 6th International Symposium on Waldenström's Macroglobulinemia (IWWM-6) Revised Response Criteria (Treon 2015), in the overall ITT population, the Brukinsa treatment group had a CR+VGPR of 29% (95%CI: 20,40), compared with 19% in the Imbruvica-treated group (95% CI: 12,30)

WM is a rare indolent lymphoma that accounts for less than 2% of non-Hodgkin lymphoma (NHL) patients

Brukinsa (Baiyueze®, zanubrutinib) is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) independently developed by BeiGene scientists.

In November 2019, Brukinsa (Baiyueze®, zanubrutinib) was the first to receive accelerated approval from the U.

In China, Brukinsa (Baiyueze®, zanubrutinib) has received 3 approvals: (1) In June 2020, it was conditionally approved for the treatment of adult patients with MCL who have received at least one prior therapy; ( 2) In June 2020, conditionally approved for the treatment of adult chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients who have received at least one prior therapy; (3) June 2021, Conditionally approved for the treatment of adult patients with WM who have received at least one prior therapy

Brukinsa (Baiyueze®, zanubrutinib) is the same class of drugs as Imbruvica (Chinese trade name: Yike®, generic name: ibrutinib, ibrutinib), a blockbuster anticancer drug on the market

Imbruvica (Yike®, ibrutinib) is a blockbuster BTK inhibitor marketed by Johnson & Johnson and AbbVie, which exerts anti-cancer effects by blocking the BTK required for cancer cell proliferation and metastasis

Since its launch in 2013, Imbruvica has received 11 US FDA approvals in a total of 6 disease areas including 5 B-cell hematological cancers and chronic graft-versus-host disease (cGVHD): with or without 17p deletion mutation (del17p) Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) with or without 17p deletion mutation (del17p), Waldenström macroglobulinemia (WM), previously treated mantle cell lymphoma (MCL) , Marginal zone lymphoma (MZL) requiring systemic therapy and at least one anti-CD20 therapy, chronic graft-versus-host disease (cGVHD) failing one or more systemic therapies

AbbVie and Johnson & Johnson are currently advancing a large clinical oncology development program for Imbruvica

Note: The original text has been deleted

Original source: BeiGene Announces Approval for BRUKINSA (zanubrutinib) by Swissmedic for Treatment of Adult Patients with Waldenström's Macroglobulinemia