Approval of brexucabtagene autoleucel for adults with relapsed and refractory acute lymphocytic leukemia

被引：28
作者：
Frey, Noelle, V [1 ]
机构：
[1] Hosp Univ Penn, Abramson Canc Ctr, Div Hematol Oncol, Cell Therapy & Transplant, 3400 Spruce St, Philadelphia, PA 19104 USA
来源：
BLOOD | 2022年 / 140卷 / 01期
关键词：
CAR-T-CELLS; B-CELL; YOUNG-ADULTS; THERAPY; CHILDREN;
D O I：
10.1182/blood.2021014892
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
In October 2021, brexucabtagene autoleucel became the first anti-CD19 chimeric antigen receptor T-cell product to receive approval from the Food and Drug Administration to treat adults with relapsed and refractory B-cell acute lymphoblastic leukemia. The approval is based on results from the Zuma-3 trial and significantly widens treatment options for this patient population. In this article, we review outcomes from this study and its implications.
引用
收藏
页码：11 / 15
页数：5
相关论文
共 30 条
  • [1] Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study
    Abramson, Jeremy S.
    Palomba, M. Lia
    Gordon, Leo I.
    Lunning, Matthew A.
    Wang, Michael
    Arnason, Jon
    Mehta, Amitkumar
    Purev, Enkhtsetseg
    Maloney, David G.
    Andreadis, Charalambos
    Sehgal, Alison
    Solomon, Scott R.
    Ghosh, Nilanjan
    Albertson, Tina M.
    Garcia, Jacob
    Kostic, Ana
    Mallaney, Mary
    Ogasawara, Ken
    Newhall, Kathryn
    Kim, Yeonhee
    Li, Daniel
    Siddiqi, Tanya
    [J]. LANCET, 2020, 396 (10254) : 839 - 852
  • [2] Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies
    Benjamin, Reuben
    Graham, Charlotte
    Yallop, Deborah
    Jozwik, Agnieszka
    Mirci-Danicar, Oana C.
    Lucchini, Giovanna
    Pinner, Danielle
    Jain, Nitin
    Kantarjian, Hagop
    Boissel, Nicolas
    Maus, Marcela V.
    Frigault, Matthew J.
    Baruchel, Andre
    Mohty, Mohamad
    Gianella-Borradori, Athos
    Binlich, Florence
    Balandraud, Svetlana
    Vitry, Fabien
    Thomas, Elisabeth
    Philippe, Anne
    Fouliard, Sylvain
    Dupouy, Sandra
    Marchiq, Ibtissam
    Almena-Carrasco, Maria
    Ferry, Nicolas
    Arnould, Sylvain
    Konto, Cyril
    Veys, Paul
    Qasim, Waseem
    [J]. LANCET, 2020, 396 (10266) : 1885 - 1894
  • [3] DeAngelo DJ, 2017, J IMMUNOTHER CANCER, V5
  • [4] Frey Noelle, 2019, Biol Blood Marrow Transplant, V25, pe123, DOI 10.1016/j.bbmt.2018.12.756
  • [5] Optimizing Chimeric Antigen Receptor T-Cell Therapy for Adults With Acute Lymphoblastic Leukemia
    Frey, Noelle, V
    Shaw, Pamela A.
    Hexner, Elizabeth O.
    Pequignot, Edward
    Gill, Saar
    Luger, Selina M.
    Mangan, James K.
    Loren, Alison W.
    Perl, Alexander E.
    Maude, Shannon L.
    Grupp, Stephan A.
    Shah, Nirav N.
    Gilmore, Joan
    Lacey, Simon F.
    Melenhorst, Jos J.
    Levine, Bruce L.
    June, Carl H.
    Porter, David L.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (05) : 415 - 422
  • [6] Preemptive mitigation of CD19 CAR T-cell cytokine release syndrome without attenuation of antileukemic efficacy
    Gardner, Rebecca A.
    Ceppi, Francesco
    Rivers, Julie
    Annesley, Colleen
    Summers, Corinne
    Taraseviciute, Agne
    Gust, Juliane
    Leger, Kasey J.
    Tarlock, Katherine
    Cooper, Todd M.
    Finney, Olivia C.
    Brakke, Hannah
    Li, Daniel H.
    Park, Julie R.
    Jensen, Michael C.
    [J]. BLOOD, 2019, 134 (24) : 2149 - 2158
  • [7] Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults
    Gardner, Rebecca A.
    Finney, Olivia
    Annesley, Colleen
    Brakke, Hannah
    Summers, Corinne
    Leger, Kasey
    Bleakley, Marie
    Brown, Christopher
    Mgebroff, Stephanie
    Kelly-Spratt, Karen S.
    Hoglund, Virginia
    Lindgren, Catherine
    Oron, Assaf P.
    Li, Daniel
    Riddell, Stanley R.
    Park, Julie R.
    Jensen, Michael C.
    [J]. BLOOD, 2017, 129 (25) : 3322 - 3331
  • [8] Chimeric Antigen Receptor-Modified T Cells for Acute Lymphoid Leukemia
    Grupp, Stephan A.
    Kalos, Michael
    Barrett, David
    Aplenc, Richard
    Porter, David L.
    Rheingold, Susan R.
    Teachey, David T.
    Chew, Anne
    Hauck, Bernd
    Wright, J. Fraser
    Milone, Michael C.
    Levine, Bruce L.
    June, Carl H.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (16) : 1509 - 1518
  • [9] Factors associated with durable EFS in adult B-cell ALL patients achieving MRD-negative CR after CD19 CAR T-cell therapy
    Hay, Kevin A.
    Gauthier, Jordan
    Hirayama, Alexandre V.
    Voutsinas, Jenna M.
    Wu, Qian
    Li, Daniel
    Gooley, Ted A.
    Cherian, Sindhu
    Chen, Xueyan
    Pender, Barbara S.
    Hawkins, Reed M.
    Vakil, Aesha
    Steinmetz, Rachel N.
    Schoch, Gary
    Chapuis, Aude G.
    Till, Brian G.
    Kiem, Hans-Peter
    Ramos, Jorge D.
    Shadman, Mazyar
    Cassaday, Ryan D.
    Acharya, Utkarsh H.
    Riddell, Stanley R.
    Maloney, David G.
    Turtle, Cameron J.
    [J]. BLOOD, 2019, 133 (15) : 1652 - 1663
  • [10] Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia
    Kantarjian, Hagop
    Stein, Anthony
    Goekbuget, Nicola
    Fielding, Adele K.
    Schuh, Andre C.
    Ribera, Josep-Maria
    Wei, Andrew
    Dombret, Herve
    Foa, Robin
    Bassan, Renato
    Arslan, Onder
    Sanz, Miguel A.
    Bergeron, Julie
    Demirkan, Fatih
    Lech-Maranda, Ewa
    Rambaldi, Alessandro
    Thomas, Xavier
    Horst, Heinz-August
    Brueggemann, Monika
    Klapper, Wolfram
    Wood, Brent L.
    Fleishman, Alex
    Nagorsen, Dirk
    Holland, Christopher
    Zimmerman, Zachary
    Topp, Max S.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2017, 376 (09) : 836 - 847
123