Kim, Nina
Mayo Clinic
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Citations 2
Advancing drug development in myelodysplastic syndromes
McGraw, Kathy L. , Cunningham, Lea, Kim, Nina , Jen, Emily Y. , Ehrlich, Lori A. , Aplan, Peter D. , Garcia‐Manero, Guillermo , Foran, James M. , Zeidan, Amer M., Scott, Bart L. , Buckstein, Rena , Tinsley-Vance, Sara, Verma, Amit , Wroblewski, Tanya, Pavletic, Steven Z. , Zeidan, Amer M. , Verma, Amit , Kim, Nina , Jen, Emily Y , Ehrlich, Lori A , Aplan, Peter D , Garcia, Jacqueline S , Komrokji, Rami S , Sekeres, Mikkael A , Scott, Bart , Verma, Amit , Zeidan, Amer M , Mina, Alain , Calvo, Katherine R. , Garcia, Jacqueline S. , Dezern, Amy Elizabeth , Komrokji, Rami S. , Sekeres, Mikkael A. , Norsworthy, Kelly J.
Blood Advances | December 30, 2024 | Volume: 9 | Issue: 5 | Pages: 1095-1104
10.1182/bloodadvances.2024014865
Abstract Myelodysplastic syndromes/neoplasms (MDSs) are heterogeneous stem cell malignancies characterized by poor prognosis and no curative therapies outside of allogeneic hematopoietic stem cell transplantation. Despite some recent approvals by the US Food and Drug Administration, (eg, luspatercept, ivosidenib, decitabine/cedazuridine, and imetelstat), there has been little progress in the development of truly transformative therapies for the treatment of patients with MDS. Challenges to advancing drug development in MDS are multifold but may be grouped into specific categories, including criteria for risk stratification and eligibility, response definitions, time-to-event end points, transfusion end points, functional assessments, and biomarker development. Strategies to address these challenges and optimize future clinical trial design for patients with MDS are presented here.
An agenda to advance research in myelodysplastic syndromes: a TOP 10 priority list from the first international workshop in MDS
Stahl, Maximilian , Wei, Andrew H. , Savona, Michael R. , Xu, Mina L. , Xie, Zhuoer , Sanz, Guillermo , Sallman, David A. , Patnaik, Mrinal M. , Padron, Eric , Odenike, Olatoyosi , Nazha, Aziz , Nimer, Stephen D. , Majeti, Ravindra , Little, Richard F. , Gore, Steven D. , Kutchroo, Vijay, Kim, Tae Kon , Kim, Nina , Hasserjian, Robert P. , Greenberg, Peter L. , Fenaux, Pierre , Churpek, Jane E. , Brunner, Andrew M. , Borate, Uma , Bennett, John M. , Platzbecker, Uwe , Buckstein, Rena , Zeidan, Amer M. , Wei, Andrew H , Savona, Michael R , Xie, Zhuoer , Taylor, Justin , Sanz, Guillermo F , Santini, Valeria , Roboz, Gail J , Patnaik, Mrinal , Little, Richard F , Komrokji, Rami S , Kim, Tae Kon , Kim, Nina , Hourigan, Christopher S , Halene, Stephanie , Griffiths, Elizabeth A. , Greenberg, Peter L , Daver, Naval , Carraway, Hetty E. , Bejar, Rafael , Boultwood, Jacqueline , Loghavi, Sanam , Platzbecker, Uwe , Steensma, David P , Majeti, Ravindra , Zeidan, Amer M , Churpek, Jane E , Abdel‐Wahab, Omar , Starczynowski, Daniel T. , Santini, Valeria , Roboz, Gail J. , List, Alan F. , Komrokji, Rami S. , Hourigan, Christopher S. , Figueroa, María E. , Efficace, Fabio , Dezern, Amy Elizabeth , Della Porta, Matteo Giovanni , Daver, Naval , Boultwood, Jacqueline , Loghavi, Sanam , Bewersdorf, Jan Philipp , Steensma, David P. , Sekeres, Mikkael A. , Churpek, Jane
Blood Advances | October 19, 2022 | Volume: 7 | Issue: 12 | Pages: 2709-2714