Duvelisib: First Global Approval

被引:109
作者
Blair, Hannah A. [1 ]
机构
[1] Springer, Private Bag 65901, Auckland 0754, New Zealand
关键词
IPI-145; DUVELISIB; INHIBITOR; PI3K-DELTA; GAMMA; SIGNALS;
D O I
10.1007/s40265-018-1013-4
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Duvelisib (Copiktra) is a small-molecule inhibitor of phosphatidylinositol-3 kinase that has been developed as an oral treatment for various cancer indications. In September 2018, duvelisib received its first global approval in the USA for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL) after at least two prior therapies. Duvelisib was also granted accelerated approval in the USA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Clinical development for various haematological malignancies is ongoing worldwide, as well as preclinical development for solid tumours in the USA. This article summarizes the milestones in the development of duvelisib leading to these first approvals for CLL/SLL and FL.
引用
收藏
页码:1847 / 1853
页数:7
相关论文
共 18 条
[1]   The phosphoinositide-3-kinase (PI3K)-delta and gamma inhibitor, IPI-145 (Duvelisib), overcomes signals from the PI3K/AKT/S6 pathway and promotes apoptosis in CLL [J].
Balakrishnan, K. ;
Peluso, M. ;
Fu, M. ;
Rosin, N. Y. ;
Burger, J. A. ;
Wierda, W. G. ;
Keating, M. J. ;
Faia, K. ;
O'Brien, S. ;
Kutok, J. L. ;
Gandhi, V. .
LEUKEMIA, 2015, 29 (09) :1811-1822
[2]  
Casulo C, 2016, HAEMATOLOGICA, V101, P104
[3]  
Davids M, 2018, 23 C EUR HAEM ASS
[4]   IPI-145 antagonizes intrinsic and extrinsic survival signals in chronic lymphocytic leukemia cells [J].
Dong, Shuai ;
Guinn, Daphne ;
Dubovsky, Jason A. ;
Zhong, Yiming ;
Lehman, Amy ;
Kutok, Jeffery ;
Woyach, Jennifer A. ;
Byrd, John C. ;
Johnson, Amy J. .
BLOOD, 2014, 124 (24) :3583-3586
[5]  
Flinn I, 2016, BLOOD, V128
[6]   The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL [J].
Flinn, Ian W. ;
Hillmen, Peter ;
Montillo, Marco ;
Nagy, Zsolt ;
Illes, Arpad ;
Etienne, Gabriel ;
Delgado, Julio ;
Kuss, Bryone J. ;
Tam, Constantine S. ;
Gasztonyi, Zoltan ;
Offner, Fritz ;
Lunin, Scott ;
Bosch, Francesco ;
Davids, Matthew S. ;
Lamanna, Nicole ;
Jaeger, Ulrich ;
Ghia, Paolo ;
Cymbalista, Florence ;
Portell, Craig A. ;
Skarbnik, Alan P. ;
Cashen, Amanda F. ;
Weaver, David T. ;
Kelly, Virginia M. ;
Turnbull, Barry ;
Stilgenbauer, Stephan .
BLOOD, 2018, 132 (23) :2446-2455
[7]   Duvelisib, a novel oral dual inhibitor of PI3K-δ,γ, is clinically active in advanced hematologic malignancies [J].
Flinn, Ian W. ;
O'Brien, Susan ;
Kahl, Brad ;
Patel, Manish ;
Oki, Yasuhiro ;
Foss, Francine F. ;
Porcu, Pierluigi ;
Jones, Jeffrey ;
Burger, Jan A. ;
Jain, Nitin ;
Kelly, Virginia M. ;
Allen, Kerstin ;
Douglas, Mark ;
Sweeney, Jennifer ;
Kelly, Patrick ;
Horwitz, Steven .
BLOOD, 2018, 131 (08) :877-887
[8]  
Flinn IW, 2015, BLOOD, V126
[9]   The PRIMO study: A phase 2 study of duvelisib efficacy and safety in patients with relapsed or refractory peripheral t-cell lymphoma (PTCL). [J].
Horwitz, Steven M. ;
Soto, Jasminder ;
Youssoufian, Hagop ;
Lloyd, Deborah ;
Le, Ngocdiep T. .
JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (15)
[10]   Activity of the PI3K-δ,γ inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma [J].
Horwitz, Steven M. ;
Koch, Raphael ;
Porcu, Pierluigi ;
Oki, Yasuhiro ;
Moskowitz, Alison ;
Perez, Megan ;
Myskowski, Patricia ;
Officer, Adam ;
Jaffe, Jacob D. ;
Morrow, Sara N. ;
Allen, Kerstin ;
Douglas, Mark ;
Stern, Howard ;
Sweeney, Jennifer ;
Kelly, Patrick ;
Kelly, Virginia ;
Aster, Jon C. ;
Weaver, David ;
Foss, Francine M. ;
Weinstock, David M. .
BLOOD, 2018, 131 (08) :888-898