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The safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The overall remission rate within three months of treatment was 43%.
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The FDA approved tisagenlecleucel with a Risk Evaluation and Mitigation Strategy (REMS) program, because of the associated risk for cytokine release syndrome (CRS) and neurologic adverse events with this immunotherapy.
The FDA required that clinicians who dispense tisagenlecleucel are specially certified on prescribing, dispensing, and administering this medication and on recognizing and managing CRS and the associated neurologic adverse reactions.
Since the CD199 antigen is also present on normal B-cells, and Kymriah will also destroy those normal B cells that produce antibodies, there may be an increased risk of infections for a prolonged period of time.
Gene therapy involves a whole lot of complicated sets of activities involving tissue targeting, cellular trafficking, delivery of genes to organs, safety of the vector, activity of therapeutic protein, etc.
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