The thorny road to drug approval for myelodysplastic syndromes

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At the recent ASCO annual meeting, within hematologic malignancies, therapies for multiple myeloma stole the show, comme d’habitude. 

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Mikkael A. Sekeres, MD, MS
Professor of medicine, Chief, Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami
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Long-term results from the phase III CARTITUDE-4 study show a single infusion of Carvykti (ciltacabtagene autoleucel) significantly extended overall survival in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, reducing the risk of death by 45% versus standard therapies of pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide and dexamethasone. 
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. 
Mikkael A. Sekeres, MD, MS
Professor of medicine, Chief, Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami

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