Industry, FDA, Friends focus on data needed to speed up development of gene and cell therapies

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Can data from one CAR T-cell therapy be used to inform FDA’s review of other CAR T products? 

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Matthew Bin Han Ong
Matthew Bin Han Ong
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Data from the IMROZ phase III trial demonstrated Sarclisa (isatuximab), in combination with standard-of-care bortezomib, lenalidomide, and dexamethasone (VRd) followed by Sarclisa-Rd (the IMROZ regimen), significantly reduced the risk of disease progression or death by 40%, compared to VRd followed by Rd in patients with newly-diagnosed multiple myeloma not eligible for transplant. 
Matthew Bin Han Ong
Matthew Bin Han Ong

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