Recently, BeiGene announced that Baiyue Ze& Reg; Zebutinib has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in combination with the anti-CD20 monoclonal antibody Otuzumab to treat adult patients with recurrent or refractory (R/R) follicular lymphoma (FL) who have undergone at least second-line systemic treatment. This approval also marks the approval of the fifth indication for B-cell malignancy by Baiyue Ze in the United States.
Mehrdad Mobasher, Chief Medical Officer of Haematology at Baekje, said, "The accelerated approval of Baekje is of great significance as it provides the first and only BTK inhibitor treatment option for American follicular lymphoma patients who have failed initial treatment or have relapsed.". Baiyue Ze is the only BTK inhibitor that has shown efficacy in this type of malignant tumor to date. It has been approved for five tumor indications and has the widest coverage of indications among similar drugs worldwide. This fully demonstrates the differentiated clinical characteristics of Baiyue Ze, as well as our unwavering determination to bring this important treatment option to patients worldwide
Baiyue Ze has been approved for multiple indications in 70 markets worldwide, including the United States, the European Union, the United Kingdom, Canada, Australia, China, South Korea, and Switzerland, and is currently developing more indications worldwide. As of now, the Baiyue Ze Global Clinical Development Project has enrolled over 5000 participants in 29 countries and regions.