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On October 8, BeiGene announced that its product Baiyueze® (Zebutinib) was approved in Australia for the treatment of adult patients with Fahrenheit's macroglobulinemia who had previously received at least one therapy, or as a first-line therapy It is used to treat patients who are not suitable for chemoimmunotherapy
.
In addition, Baiyueze® has recently been approved by the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one treatment in the past
.
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
.
WM is a rare and slowly progressing lymphoma, which accounts for less than 2% of NHL patients.
BeiGene has submitted a reimbursement application for Baiyueze® to the Pharmaceutical Benefits Advisory Committee of Australia (PBAC)
.
In this first application, BeiGene expects that WM's reimbursement application will enter the accelerated resolution channel in order to determine the time when WM will be included in the reimbursement
The marketing authorization of Baiyueze® for the treatment of WM in Australia is based on the effectiveness of the ASPEN trial
.
ASPEN is a randomized, open-label, multi-center phase 3 trial (NCT03053440), which aims to evaluate Baiyueze® versus ibrutinib for relapsed or refractory (R/R) or refractory (R/R) or The effect of treatment-naive (TN) WM patients
In the ASPEN trial, a total of 101 WM patients were randomly assigned to receive Baiyueze® treatment, and 5% of the patients discontinued treatment due to adverse events, including cardiac hypertrophy, neutropenia, plasma cell myeloma, and subdural hemorrhage
.
14.
The overall safety profile of Baiyueze® is based on the combined data of 779 patients with B-cell malignant tumors who have received Baiyueze® in clinical trials
.
The most common adverse reactions of Baiyueze® (incidence ≥20%) are neutropenia, thrombocytopenia, upper respiratory tract infection, bleeding/hematoma, rash, contusion, anemia, skeletal muscle pain, diarrhea, pneumonia, Cough
The recommended dose of Baiyueze® is 160 mg twice a day or 320 mg once a day.
It can be taken orally on an empty stomach or after meals
.
The dosage can be adjusted according to adverse reactions.
