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Recently, the US FDA approved Zebutinib (Brukinsa) for the treatment of adults with Waldenstrom's macroglobulinemia (WM), and the application was granted Fast Track and Orphan Drug Designation
.
.
The FDA's approval of Zebutinib is mainly based on the effectiveness of a randomized, active-controlled, open-label Phase III clinical trial
.
This study compared the efficacy of Zebutinib and Ibrutinib in WM patients with MYD88 mutations
.
The patients in cohort 1 were randomized to receive zebutinib 160 mg twice a day or ibrutinib 420 mg once a day at a ratio of 1:1 until the disease progressed or unacceptable toxicity occurred
.
Cohort 2 recruited MYD88 wild-type (MYD88WT) or MYD88 unknown mutant WM patients, and received zebutinib 160 mg twice a day
.
.
This study compared the efficacy of Zebutinib and Ibrutinib in WM patients with MYD88 mutations
.
The patients in cohort 1 were randomized to receive zebutinib 160 mg twice a day or ibrutinib 420 mg once a day at a ratio of 1:1 until the disease progressed or unacceptable toxicity occurred
.
Cohort 2 recruited MYD88 wild-type (MYD88WT) or MYD88 unknown mutant WM patients, and received zebutinib 160 mg twice a day
.
The primary efficacy endpoint of the trial is the partial response rate (PR) or the partial response rate (VGPR) assessed by the independent review committee (IRC) in the overall intention-to-treat (ITT) population; another measure of efficacy outcome is the duration of response (DOR) )
.
The test results showed that the remission rate [CR (complete remission rate)+VGPR+PR] of the Zebutinib group was 77.
5%; the 12-month event-free DOR was 94.
4%
.
In cohort 2, the remission rate (CR+VGPR+PR) assessed by IRC was 50%
.
.
The test results showed that the remission rate [CR (complete remission rate)+VGPR+PR] of the Zebutinib group was 77.
5%; the 12-month event-free DOR was 94.
4%
.
In cohort 2, the remission rate (CR+VGPR+PR) assessed by IRC was 50%
.
The most common adverse reactions (≥ 20%) reported with Zebutinib included decreased neutrophil count, upper respiratory tract infection, decreased platelet count, rash, bleeding, musculoskeletal pain, decreased hemoglobin, bruising, diarrhea, pneumonia, and Cough
.
.
The recommended dose of Zebutinib is 160 mg orally twice a day or 320 mg orally once a day
.
(Source: FDA website; Compiler: Liu Sihui)
.
(Source: FDA website; Compiler: Liu Sihui)
Recently, the US FDA approved Zebutinib (Brukinsa) for the treatment of adults with Waldenstrom's macroglobulinemia (WM), and the application was granted Fast Track and Orphan Drug Designation
.
.
The FDA's approval of Zebutinib is mainly based on the effectiveness of a randomized, active-controlled, open-label Phase III clinical trial
.
This study compared the efficacy of Zebutinib and Ibrutinib in WM patients with MYD88 mutations
.
The patients in cohort 1 were randomized to receive zebutinib 160 mg twice a day or ibrutinib 420 mg once a day at a ratio of 1:1 until the disease progressed or unacceptable toxicity occurred
.
Cohort 2 recruited MYD88 wild-type (MYD88WT) or MYD88 unknown mutant WM patients, and received zebutinib 160 mg twice a day
.
.
This study compared the efficacy of Zebutinib and Ibrutinib in WM patients with MYD88 mutations
.
The patients in cohort 1 were randomized to receive zebutinib 160 mg twice a day or ibrutinib 420 mg once a day at a ratio of 1:1 until the disease progressed or unacceptable toxicity occurred
.
Cohort 2 recruited MYD88 wild-type (MYD88WT) or MYD88 unknown mutant WM patients, and received zebutinib 160 mg twice a day
.
The primary efficacy endpoint of the trial is the partial response rate (PR) or the partial response rate (VGPR) assessed by the independent review committee (IRC) in the overall intention-to-treat (ITT) population; another measure of efficacy outcome is the duration of response (DOR) )
.
The test results showed that the remission rate [CR (complete remission rate)+VGPR+PR] of the Zebutinib group was 77.
5%; the 12-month event-free DOR was 94.
4%
.
In cohort 2, the remission rate (CR+VGPR+PR) assessed by IRC was 50%
.
.
The test results showed that the remission rate [CR (complete remission rate)+VGPR+PR] of the Zebutinib group was 77.
5%; the 12-month event-free DOR was 94.
4%
.
In cohort 2, the remission rate (CR+VGPR+PR) assessed by IRC was 50%
.
The most common adverse reactions (≥ 20%) reported with Zebutinib included decreased neutrophil count, upper respiratory tract infection, decreased platelet count, rash, bleeding, musculoskeletal pain, decreased hemoglobin, bruising, diarrhea, pneumonia, and Cough
.
.
The recommended dose of Zebutinib is 160 mg orally twice a day or 320 mg orally once a day
.
(Source: FDA website; Compiler: Liu Sihui)
.
(Source: FDA website; Compiler: Liu Sihui)
Recently, the US FDA approved Zebutinib (Brukinsa) for the treatment of adults with Waldenstrom's macroglobulinemia (WM), and the application was granted Fast Track and Orphan Drug Designation
.
.
The FDA's approval of Zebutinib is mainly based on the effectiveness of a randomized, active-controlled, open-label Phase III clinical trial
.
This study compared the efficacy of Zebutinib and Ibrutinib in WM patients with MYD88 mutations
.
The patients in cohort 1 were randomized to receive zebutinib 160 mg twice a day or ibrutinib 420 mg once a day at a ratio of 1:1 until the disease progressed or unacceptable toxicity occurred
.
Cohort 2 recruited MYD88 wild-type (MYD88WT) or MYD88 unknown mutant WM patients, and received zebutinib 160 mg twice a day
.
Disease disease disease.
This study compared the efficacy of Zebutinib and Ibrutinib in WM patients with MYD88 mutations
.
The patients in cohort 1 were randomized to receive zebutinib 160 mg twice a day or ibrutinib 420 mg once a day at a ratio of 1:1 until the disease progressed or unacceptable toxicity occurred
.
Cohort 2 recruited MYD88 wild-type (MYD88WT) or MYD88 unknown mutant WM patients, and received zebutinib 160 mg twice a day
.
The primary efficacy endpoint of the trial is the partial response rate (PR) or the partial response rate (VGPR) assessed by the independent review committee (IRC) in the overall intention-to-treat (ITT) population; another measure of efficacy outcome is the duration of response (DOR) )
.
The test results showed that the remission rate [CR (complete remission rate)+VGPR+PR] of the Zebutinib group was 77.
5%; the 12-month event-free DOR was 94.
4%
.
In cohort 2, the remission rate (CR+VGPR+PR) assessed by IRC was 50%
.
.
The test results showed that the remission rate [CR (complete remission rate)+VGPR+PR] of the Zebutinib group was 77.
5%; the 12-month event-free DOR was 94.
4%
.
In cohort 2, the remission rate (CR+VGPR+PR) assessed by IRC was 50%
.
The most common adverse reactions (≥ 20%) reported with Zebutinib included decreased neutrophil count, upper respiratory tract infection, decreased platelet count, rash, bleeding, musculoskeletal pain, decreased hemoglobin, bruising, diarrhea, pneumonia, and Cough
.
Adverse reactions adverse reactions adverse reactions.
The recommended dose of Zebutinib is 160 mg orally twice a day or 320 mg orally once a day
.
(Source: FDA website; Compiler: Liu Sihui)
.
(Source: FDA website; Compiler: Liu Sihui)
