BeiGene announced that Baiyueze® (Zebutinib) was approved for the treatment of mantle cell lymphoma

On October 11, BeiGene announced that Baiyueze® (Zebutinib) has been approved in Australia for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least one therapy
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4 days ago, the product was approved for the first time in Australia for the treatment of adult patients with Huashi Macroglobulinemia (WM) who have previously received at least one therapy, or as a first-line therapy for patients who are not suitable for chemoimmunotherapy
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In Australia, more than 6000 people are diagnosed with non-Hodgkin's lymphoma (NHL) each year, which is also the sixth most common cancer among Australian adults
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MCL is a type of B-cell NHL that occurs on the outer edge of the lymph node, the "mantle area"
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The median survival time of patients is 3 to 6 years, and many patients are often diagnosed in the late stages of the disease
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 Baiyueze® (Zebutinib) is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) independently developed by BeiGene scientists
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With its differentiated pharmacokinetics from other approved BTK inhibitors, Baiyueze® can inhibit the proliferation of malignant B cells in multiple disease-related tissues
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The product is currently undergoing extensive clinical trials worldwide, as a single agent or in combination with other therapies to treat a variety of B-cell malignancies
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The marketing authorization of Baiyueze® for the treatment of MCL in Australia is based on the effectiveness of two single-arm clinical trials
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In these two trials, the overall response rate (ORR) of Baiyueze® assessed by the Independent Review Committee (IRC) according to the 2014 Lugano classification criteria was 83.
7%, and ORR was defined as complete response (CR) and partial response (PR) rates The sum of
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The overall safety data of Baiyueze® comes from 779 patients with B-cell malignant tumors who have received Baiyueze® in multiple clinical trials.
The most common adverse reactions (≥ 20%) are neutropenia, Thrombocytopenia, upper respiratory tract infection, bleeding/hematoma, skin rash, contusion, anemia, skeletal muscle pain, diarrhea, pneumonia, and cough
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The most common adverse reactions ≥ Grade 3 (≥ 5%) are neutropenia, thrombocytopenia, pneumonia, and anemia
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It is reported that after the two indications of BaiGene ® have been approved by the Australian Drug Administration (TGA), Australian patients can immediately obtain BaiGene through the "Post-marketing Approval/Pre-medical Admission Drug Use Plan" sponsored by BeiGene ®
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