BeiGene 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
.

On October 7, 2021, Baiyueze® was approved for the first time in Australia for the treatment of adult patients with Huashi Macroglobulinemia (WM) who have received at least one therapy in the past, or as a first-line therapy for the treatment of unsuitable Chemoimmunotherapy patients

BeiGene has submitted a reimbursement application for Baiyueze® to the Pharmaceutical Benefits Advisory Committee of Australia (PBAC), and the MCL indication has been recommended to be included in the reimbursement subsidy list in July 2021
.

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
.

[2] MCL is a type of B-cell NHL that occurs on the outer edge of the lymph node, the "mantle area"

The marketing authorization of Baiyueze® for the treatment of MCL in Australia is based on the effectiveness of two single-arm clinical trials
.

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.

In a multicenter phase 2 trial of zebutinib in patients with relapsed or refractory (R/R) MCL, BGB-3111-206 (NCT03206970), when the median follow-up time was 18.
4 months, the ORR was 83.
7% (95% CI: 74.
2.
90.
8), including 68.
6% complete remission (CR, verified by FDG-PET scan), 15.
1% partial remission (PR); median duration of remission (DoR) was 19.
5 months (95 % CI: 16.
6.
NE)
.

In the global phase 1/2 trial BGB-3111-AU-003 (NCT02343120), when the median follow-up time was 14.

Among the 118 MCL patients who had received at least one treatment in the past, 13.
6% of patients discontinued treatment due to adverse events that occurred during the trial after receiving Baiyueze® treatment.
The most common adverse event was pneumonia (3.
4%)
.

3.

The overall safety data of Baiyueze® comes from 779 patients with B-cell malignant tumors who have received Baiyueze® treatment 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
.

The most common adverse reactions ≥ Grade 3 (≥ 5%) were neutropenia, thrombocytopenia, pneumonia, and anemia

The recommended dose of Baiyueze® is 160 mg twice daily or 320 mg once daily, either on an empty stomach or after meals
.

The dosage of the medication can be adjusted according to the adverse reactions.

references:

references:

[1] BRUKINSA Australia Product Information.

[1] BRUKINSA Australia Product Information.

[2] https:// Accessed August 2021.

[3] https:// August 2021.

[3] https:// August 2021.