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On September 22, 2021, the U.
S.
Food and Drug Administration approved Rucotinib for the treatment of chronic graft-versus-host disease (cGVHD) adults and children ≥12 years old who have failed first-line or two-line systemic therapy
.
The approval evaluated the efficacy in the REACH-3 study (NCT03112603).
The REACH-3 study is a randomized, open-label, multi-center clinical trial that compared rucotinib and Best Available Therapy (BAT) to allogeneic After hematopoietic stem cell transplantation failed hormone therapy for cGVHD, 329 patients were randomly assigned (1:1) to receive rucotinib 10 mg (twice a day) or BAT treatment
.
The primary study endpoint used to support this approval is the overall response rate (ORR) on Day 1 of Cycle 7
.
The ORR of the Rucotinib group was 70% (95% CI: 63%-77%), the ORR of the BAT group was 57% (95% CI: 49%-65%), and the difference in remission rate was 13% (95% CI: 3%-23%)
.
The median duration of remission (first remission to progression, death, or initiation of new cGVHD systemic treatment) in the rucotinib group and BAT group were 4.
2 months (95% CI: 3.
2-6.
7) and 2.
1 months ( 95% CI: 1.
6-3.
2).
The median time from the first remission to death or the start of new cGVHD systemic treatment for patients in the Rucotinib and BAT groups was 25 months (95% CI: 16.
8-NE) and 5.
6, respectively Months (95% CI: 4.
1-7.
8)
.
The most common (incidence rate>35%) hematological adverse reactions in the Rucotinib group were anemia and thrombocytopenia, and the most common (incidence rate ≥20%) non-hematological adverse reactions were infection and viral infection
.
The recommended starting dose of rucotinib for the treatment of cGVHD is 10 mg orally twice a day
.
Reference source: https:// Stamp "read the original text" and we will make progress together
S.
Food and Drug Administration approved Rucotinib for the treatment of chronic graft-versus-host disease (cGVHD) adults and children ≥12 years old who have failed first-line or two-line systemic therapy
.
The approval evaluated the efficacy in the REACH-3 study (NCT03112603).
The REACH-3 study is a randomized, open-label, multi-center clinical trial that compared rucotinib and Best Available Therapy (BAT) to allogeneic After hematopoietic stem cell transplantation failed hormone therapy for cGVHD, 329 patients were randomly assigned (1:1) to receive rucotinib 10 mg (twice a day) or BAT treatment
.
The primary study endpoint used to support this approval is the overall response rate (ORR) on Day 1 of Cycle 7
.
The ORR of the Rucotinib group was 70% (95% CI: 63%-77%), the ORR of the BAT group was 57% (95% CI: 49%-65%), and the difference in remission rate was 13% (95% CI: 3%-23%)
.
The median duration of remission (first remission to progression, death, or initiation of new cGVHD systemic treatment) in the rucotinib group and BAT group were 4.
2 months (95% CI: 3.
2-6.
7) and 2.
1 months ( 95% CI: 1.
6-3.
2).
The median time from the first remission to death or the start of new cGVHD systemic treatment for patients in the Rucotinib and BAT groups was 25 months (95% CI: 16.
8-NE) and 5.
6, respectively Months (95% CI: 4.
1-7.
8)
.
The most common (incidence rate>35%) hematological adverse reactions in the Rucotinib group were anemia and thrombocytopenia, and the most common (incidence rate ≥20%) non-hematological adverse reactions were infection and viral infection
.
The recommended starting dose of rucotinib for the treatment of cGVHD is 10 mg orally twice a day
.
Reference source: https:// Stamp "read the original text" and we will make progress together
