Application for new indication of zebutinib was accepted by FDA and EMA

Application for new indication of zebutinib was accepted by FDA and EMA
Zebrutinib (zanubrutinib, trade name: Baiyueze) is an anticancer drug independently developed by Baiji Shenzhou, China. is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK) that is being tested as a single agent or in combination with other therapies in a variety of lymphomas.
Recently, Baiji Shenzhou announced that a number of new indications submitted by Zebutinib overseas have been accepted. Among them, the new indication application for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was accepted by the US Food and Drug Administration (FDA); the new indication application for the treatment of chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL) was accepted by the European Medicines Agency (EMA).

In the United States, Zeboutinib has been approved for three indications: in November 2019, for the treatment of adult patients with mantle cell lymphoma (MCL) who had received at least one prior therapy; in August 2021, for the treatment of adult patients with Walden′s macroglobulinemia (WM); and in September 2021, for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who had received at least one prior anti-CD20 therapy.
The application for new indications for zeboutinib in the United States for CLL/SLL is based on data from two pivotal, randomized, global Phase 3 studies (ALPINE and SEQUOIA) in patients with CLL/SLL and eight supporting studies in B- cell malignancies. The two phase 3 studies included patients from 17 countries and regions. The results of the study showed that CLL patients treated with zebitinib were generally well tolerated, had a low incidence of atrial fibrillation, and showed strong efficacy compared with a marketed BTK inhibitor and chemoimmunotherapy.
In Europe, zebutinib was first approved in November 2021 for the treatment of adult patients with Waldenstris macroglobulinemia (WM) who have received at least one previous treatment, or as a first-line treatment for patients with WM who are not suitable for chemotherapy immunotherapy.

The new indication application for Zhebtinib in Europe for CLL is also based on two pivotal, randomized, global Phase 3 studies (ALPINE and SEQUOIA) in CLL/SLL patients. The marketing application for marginal zone lymphoma is based on the effectiveness results of two single-arm clinical trials: a global pivotal phase 2 trial MAGNOLIA in patients with relapsed and refractory marginal zone lymphoma who had received at least one previous anti-CD20 antibody-containing regimen, and a global phase 1/2 trial BGB-3111-AU-003. The two studies included patients from clinical research centers in nine countries and regions, including the United States, China, Europe, Australia and New Zealand. Preliminary results from MAGNOLIA clinical trials, including an overall response rate of up to 74.2 percent and a clinical benefit rate of nearly 90 percent, indicate that the anti-tumor activity of zebitinib is expected to benefit patients with this disease. Moreover, responses were generally consistent and generally tolerated in patients with high-risk characteristics.
So far, zebutinib has been approved by more than 20 countries and regions including the United States, China, the European Union, the United Kingdom, Canada, and Australia. At present, the drug in the global scope and more than 40 drug declaration is under review.