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On March 5, 2021, the U.
S.
Food and Drug Administration (FDA) accelerated the approval of axicabtagene ciloleucel for adult patients with relapsed and refractory follicular lymphoma (FL) who had previously received ≥2 lines of systemic therapy.
The accelerated approval is based on the single-arm, open-label, multi-center ZUMA-5 study (NCT03105336).
This study evaluated the anti-CD19 chimeric antigen receptor T cell (CAR-T) drug axicabtagene ciloleucel in adult patients with relapsed and refractory FL who had previously received ≥2 lines of systemic therapy (including anti-CD20 monoclonal antibodies and alkylating agents) In the efficacy and safety.
Axicabtagene ciloleucel is administered by intravenous infusion after the patient has received lymphoblastic chemotherapy.
The main efficacy indicators of the ZUMA-5 study are the objective response rate (ORR) and duration of response (DOR) assessed by the independent review committee.
The study conducted a main efficacy analysis of 81 patients.
The ORR reached 91% (95%CI: 83%-96%), the complete remission (CR) rate was 60%, and the median time to remission was 1 month.
DOR is not reached.
The 1-year sustained remission rate of patients in the study was 76.
2% (95% CI: 63.
9%-84.
7%).
The ORR of all patients (n=123) who underwent leukopenia in this study was 89% (95%CI: 83%-94%), and the CR rate was 62%.
The instructions for use of Axicabtagene ciloleucel contain black box warnings about cytokine release syndrome (CRS) and neurotoxicity.
Studies have shown that the incidence of CRS in patients with non-Hodgkin’s lymphoma (NHL) treated with axicabtagene ciloleucel is 88% (the incidence of CRS ≥3 is 10%), and the incidence of neurotoxic events is 81% (the incidence of neurotoxicity is ≥3 The incidence of toxic events was 26%).
The most common adverse reactions (incidence ≥20%) of Axicabtagene ciloleucel in NHL patients are CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, febrile neutropenia, nausea, infection by unknown pathogens, Loss of appetite, chills, diarrhea, tremor, musculoskeletal pain, cough, hypoxia, constipation, vomiting, arrhythmia, dizziness.
Reference source: https:// stamp "Read the original", We make progress together
S.
Food and Drug Administration (FDA) accelerated the approval of axicabtagene ciloleucel for adult patients with relapsed and refractory follicular lymphoma (FL) who had previously received ≥2 lines of systemic therapy.
The accelerated approval is based on the single-arm, open-label, multi-center ZUMA-5 study (NCT03105336).
This study evaluated the anti-CD19 chimeric antigen receptor T cell (CAR-T) drug axicabtagene ciloleucel in adult patients with relapsed and refractory FL who had previously received ≥2 lines of systemic therapy (including anti-CD20 monoclonal antibodies and alkylating agents) In the efficacy and safety.
Axicabtagene ciloleucel is administered by intravenous infusion after the patient has received lymphoblastic chemotherapy.
The main efficacy indicators of the ZUMA-5 study are the objective response rate (ORR) and duration of response (DOR) assessed by the independent review committee.
The study conducted a main efficacy analysis of 81 patients.
The ORR reached 91% (95%CI: 83%-96%), the complete remission (CR) rate was 60%, and the median time to remission was 1 month.
DOR is not reached.
The 1-year sustained remission rate of patients in the study was 76.
2% (95% CI: 63.
9%-84.
7%).
The ORR of all patients (n=123) who underwent leukopenia in this study was 89% (95%CI: 83%-94%), and the CR rate was 62%.
The instructions for use of Axicabtagene ciloleucel contain black box warnings about cytokine release syndrome (CRS) and neurotoxicity.
Studies have shown that the incidence of CRS in patients with non-Hodgkin’s lymphoma (NHL) treated with axicabtagene ciloleucel is 88% (the incidence of CRS ≥3 is 10%), and the incidence of neurotoxic events is 81% (the incidence of neurotoxicity is ≥3 The incidence of toxic events was 26%).
The most common adverse reactions (incidence ≥20%) of Axicabtagene ciloleucel in NHL patients are CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, febrile neutropenia, nausea, infection by unknown pathogens, Loss of appetite, chills, diarrhea, tremor, musculoskeletal pain, cough, hypoxia, constipation, vomiting, arrhythmia, dizziness.
Reference source: https:// stamp "Read the original", We make progress together
