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On October 29, 2021, the U.
S.
Food and Drug Administration (FDA) has accelerated the approval of asciminib for the treatment of chronic phase (CP) Philadelphia chromosome-positive chronic myelopathy who has previously received ≥2 tyrosine-therapeutic kinase inhibitors (TKI).
Department of leukemia (Ph+ CML) patients; T315I mutation CP Ph+ CML adult patients
.
The ASCEMBL study (NCT03106779) is a multicenter, randomized, active-controlled, open-label clinical trial that is evaluating the efficacy and safety of asciminib in CP Ph+ CML patients who have previously received ≥2 TKI treatments
.
A total of 233 patients were randomized (2:1) stratified according to the main cytogenetic response (MCyR) status to receive asciminib 40 mg twice daily or Bosutinib 500 mg once daily until intolerable toxicity or The treatment failed
.
The primary endpoint is the primary molecular response (MMR) at 24 weeks
.
The MMR rate for patients treated with asciminib was 25% (95% CI: 19-33), while that for patients treated with bosutinib was 13% (95% CI: 6.
5-23; p=0.
029)
.
The median follow-up time is 20 months, and the median duration of MMR has not yet been reached
.
The CABL001X2101 study (NCT02081378) is a multi-center, open-label clinical trial that is evaluating the efficacy and safety of asciminib in T315I mutant CP Ph+ CML patients
.
45 T315I mutation patients received asciminib 200mg twice a day until intolerable toxicity or treatment failure
.
The primary endpoint is MMR
.
42% (19/45, 95% CI: 28%-58%) of patients reached MMR at 24 weeks, and 49% (22/45, 95% CI: 34%-64%) of patients reached MMR at 96 weeks MMR
.
The median duration of treatment was 108 weeks (range: 2-215 weeks)
.
The most common (≥20%) adverse reactions are upper respiratory tract infection, musculoskeletal pain, fatigue, nausea, skin rash and diarrhea
.
The most common laboratory abnormalities are decreased platelet counts, increased triglycerides, decreased neutrophil counts and hemoglobin, and increased creatine kinase, alanine aminotransferase, lipase, and amylase
.
The recommended dose of asciminib for CP Ph+ CML patients who have previously received ≥2 TKI treatments is 80 mg, once a day, orally at about the same time a day, or 40 mg, twice a day, with an interval of about 12 hours
.
The recommended dose of asciminib for T315I mutant CP Ph+ CML patients is 200 mg orally twice a day with an interval of about 12 hours
.
Reference source: https:// Stamp "read the original text" and we will make progress together
S.
Food and Drug Administration (FDA) has accelerated the approval of asciminib for the treatment of chronic phase (CP) Philadelphia chromosome-positive chronic myelopathy who has previously received ≥2 tyrosine-therapeutic kinase inhibitors (TKI).
Department of leukemia (Ph+ CML) patients; T315I mutation CP Ph+ CML adult patients
.
The ASCEMBL study (NCT03106779) is a multicenter, randomized, active-controlled, open-label clinical trial that is evaluating the efficacy and safety of asciminib in CP Ph+ CML patients who have previously received ≥2 TKI treatments
.
A total of 233 patients were randomized (2:1) stratified according to the main cytogenetic response (MCyR) status to receive asciminib 40 mg twice daily or Bosutinib 500 mg once daily until intolerable toxicity or The treatment failed
.
The primary endpoint is the primary molecular response (MMR) at 24 weeks
.
The MMR rate for patients treated with asciminib was 25% (95% CI: 19-33), while that for patients treated with bosutinib was 13% (95% CI: 6.
5-23; p=0.
029)
.
The median follow-up time is 20 months, and the median duration of MMR has not yet been reached
.
The CABL001X2101 study (NCT02081378) is a multi-center, open-label clinical trial that is evaluating the efficacy and safety of asciminib in T315I mutant CP Ph+ CML patients
.
45 T315I mutation patients received asciminib 200mg twice a day until intolerable toxicity or treatment failure
.
The primary endpoint is MMR
.
42% (19/45, 95% CI: 28%-58%) of patients reached MMR at 24 weeks, and 49% (22/45, 95% CI: 34%-64%) of patients reached MMR at 96 weeks MMR
.
The median duration of treatment was 108 weeks (range: 2-215 weeks)
.
The most common (≥20%) adverse reactions are upper respiratory tract infection, musculoskeletal pain, fatigue, nausea, skin rash and diarrhea
.
The most common laboratory abnormalities are decreased platelet counts, increased triglycerides, decreased neutrophil counts and hemoglobin, and increased creatine kinase, alanine aminotransferase, lipase, and amylase
.
The recommended dose of asciminib for CP Ph+ CML patients who have previously received ≥2 TKI treatments is 80 mg, once a day, orally at about the same time a day, or 40 mg, twice a day, with an interval of about 12 hours
.
The recommended dose of asciminib for T315I mutant CP Ph+ CML patients is 200 mg orally twice a day with an interval of about 12 hours
.
Reference source: https:// Stamp "read the original text" and we will make progress together
