-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
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.