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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GSK plc announced statistically significant and clinically meaningful overall survival results from a planned interim analysis of the DREAMM-7 trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone versus daratumumab in combination with bortezomib plus dexamethasone as a second line or later treatment for relapsed or refractory multiple myeloma. 
Johnson & Johnson announced new results from the phase III CARTITUDE-4 study that show a single infusion of Carvykti (ciltacabtagene autoleucel; cilta-cel) significantly increased minimal residual disease negativity rates (10-5) in patients with relapsed or refractory multiple myeloma who were lenalidomide-refractory and had received one to three prior lines of therapy, including a proteasome inhibitor, compared to standard therapies of pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide and dexamethasone.
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. 
Mikkael A. Sekeres, MD, MS
Professor of medicine, Chief, Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami

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