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On March 26, 2021, the U.
S.
Food and Drug Administration (FDA) approved idecabtagene vicleucel for the treatment of relapsed/refractory multiple cases that have previously received ≥4-line therapies (including immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies) Adult patients with sexual myeloma.
This is the first cell-based gene therapy approved by the FDA for multiple myeloma.
Idecabtagene vicleucel is a genetically modified auto-chimeric antigen receptor (CAR) T cell therapy targeting B cell maturation antigen (BCMA).
It is customized using the patient’s own T cells.
These T cells will be collected and genetically modified.
Then it is injected into the patient's body.
A multi-center study evaluated the safety and efficacy of 127 patients with relapsed/refractory multiple myeloma (previously received ≥3 line anti-myeloma therapy, 88% of whom had previously received ≥4 line therapy).
100 patients who received idecabtagene vicleucel (dose of 300-460x106CAR-positive T cells) were evaluated for efficacy.
The main efficacy indicators are the overall response rate (ORR), complete response (CR) rate, and duration of response (DOR) assessed by the independent review committee.
The results showed that the ORR was 72% (95% CI: 62%, 81%), and the CR rate was 28% (95% CI: 19%, 38%).
It is estimated that the CR status of 65% of CR patients lasted for 12 months.
Idecabtagene vicleucel's drug instructions contain black box warnings of cytokine release syndrome (CRS), nervous system toxicity, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and long-term cytopenia.
The most common side effects of Idecabtagene vicleucel include CRS, infection, fatigue, musculoskeletal pain, and hypogammaglobulinemia.
Idecabtagene vicleucel has passed the approval of the risk assessment and mitigation strategy, which requires that medical institutions providing the therapy must be specially certified to identify and manage CRS and neurotoxicity.
In order to evaluate long-term safety, the FDA requires manufacturers to conduct post-marketing observational studies on patients treated with idecabtagene vicleucel.
Reference source: Stamp "read the original text" and we will make progress together
S.
Food and Drug Administration (FDA) approved idecabtagene vicleucel for the treatment of relapsed/refractory multiple cases that have previously received ≥4-line therapies (including immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies) Adult patients with sexual myeloma.
This is the first cell-based gene therapy approved by the FDA for multiple myeloma.
Idecabtagene vicleucel is a genetically modified auto-chimeric antigen receptor (CAR) T cell therapy targeting B cell maturation antigen (BCMA).
It is customized using the patient’s own T cells.
These T cells will be collected and genetically modified.
Then it is injected into the patient's body.
A multi-center study evaluated the safety and efficacy of 127 patients with relapsed/refractory multiple myeloma (previously received ≥3 line anti-myeloma therapy, 88% of whom had previously received ≥4 line therapy).
100 patients who received idecabtagene vicleucel (dose of 300-460x106CAR-positive T cells) were evaluated for efficacy.
The main efficacy indicators are the overall response rate (ORR), complete response (CR) rate, and duration of response (DOR) assessed by the independent review committee.
The results showed that the ORR was 72% (95% CI: 62%, 81%), and the CR rate was 28% (95% CI: 19%, 38%).
It is estimated that the CR status of 65% of CR patients lasted for 12 months.
Idecabtagene vicleucel's drug instructions contain black box warnings of cytokine release syndrome (CRS), nervous system toxicity, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and long-term cytopenia.
The most common side effects of Idecabtagene vicleucel include CRS, infection, fatigue, musculoskeletal pain, and hypogammaglobulinemia.
Idecabtagene vicleucel has passed the approval of the risk assessment and mitigation strategy, which requires that medical institutions providing the therapy must be specially certified to identify and manage CRS and neurotoxicity.
In order to evaluate long-term safety, the FDA requires manufacturers to conduct post-marketing observational studies on patients treated with idecabtagene vicleucel.
Reference source: Stamp "read the original text" and we will make progress together
