Futibatinib: First Approval

被引:50
作者
Syed, Yahiya Y. [1 ]
机构
[1] Springer Nat, Private Bag 65901, Auckland 0754, New Zealand
关键词
ADVANCED SOLID TUMORS; PHASE-I; ANTITUMOR-ACTIVITY; JAPANESE PATIENTS; INHIBITOR;
D O I
10.1007/s40265-022-01806-z
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Futibatinib (Lytgobi (R)) is an oral, covalently binding, irreversible inhibitor of fibroblast growth factor receptor (FGFR)1-4 that is being developed by Taiho Oncology and Taiho Pharmaceutical for the treatment of cancers, including cholangiocarcinoma, breast cancer, gastric cancer, urothelial cancer, oesophageal cancer and non-small cell lung cancer. Futibatinib was approved in the USA on 30 September 2022 for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harbouring FGFR2 gene fusions or other rearrangements. This article summarizes the milestones in the development of futibatinib leading to this first approval.
引用
收藏
页码:1737 / 1743
页数:7
相关论文
共 28 条
[1]   Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors [J].
Bahleda, R. ;
Meric-Bernstam, F. ;
Goyal, L. ;
Tran, B. ;
He, Y. ;
Yamamiya, I ;
Benhadji, K. A. ;
Matos, I ;
Arkenau, H-T .
ANNALS OF ONCOLOGY, 2020, 31 (10) :1405-1412
[2]   Indirect treatment comparison of futibatinib with chemotherapy and pemigatinib in cholangiocarcinoma with FGFR2 fusions/rearrangements [J].
Borad, Mitesh J. ;
Paine, Abigail ;
Wacheck, Volker ;
He, Yaohua ;
Kazerooni, Reza ;
Salimi, Tehseen ;
Bridgewater, John A. .
JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (04)
[3]   FGFR2 Extracellular Domain In-Frame Deletions Are Therapeutically Targetable Genomic Alterations That Function as Oncogenic Drivers in Cholangiocarcinoma [J].
Cleary, James M. ;
Raghavan, Srivatsan ;
Wu, Qibiao ;
Li, Yvonne Y. ;
Spurr, Liam F. ;
Gupta, Hersh, V ;
Rubinson, Douglas A. ;
Fetter, Isobel J. ;
Hornick, Jason L. ;
Nowak, Jonathan A. ;
Siravegna, Giulia ;
Goyal, Lipika ;
Shi, Lei ;
Brais, Lauren K. ;
Loftus, Maureen ;
Shinagare, Atul B. ;
Abrams, Thomas A. ;
Clancy, Thomas E. ;
Wang, Jiping ;
Patel, Anuj K. ;
Brichory, Franck ;
Chessex, Anne Vaslin ;
Sullivan, Ryan J. ;
Keller, Rachel B. ;
Denning, Sarah ;
Hill, Emma R. ;
Shapiro, Geoffrey, I ;
Pokorska-Bocci, Anna ;
Zanna, Claudio ;
Ng, Kimmie ;
Schrag, Deborah ;
Janne, Pasi A. ;
Hahn, William C. ;
Cherniack, Andrew D. ;
Corcoran, Ryan B. ;
Meyerson, Matthew ;
Daina, Antoine ;
Zoete, Vincent ;
Bardeesy, Nabeel ;
Wolpin, Brian M. .
CANCER DISCOVERY, 2021, 11 (10) :2488-2505
[4]   Futibatinib in combination with fulvestrant in patients with metastatic breast cancer (MBC) harboring high-level FGFR1 amplification: Preliminary data from a phase 2 study [J].
Damodaran, Senthil ;
Unni, Nisha ;
Giridhar, Karthik V. ;
Daniel, Brooke ;
Howell, Sacha ;
Costa, Luis ;
Ferreira, Marta ;
Shimura, Masashi ;
Tomlinson, Gareth ;
Gil, Maciej ;
Turner, Nicholas .
CANCER RESEARCH, 2022, 82 (04)
[5]  
European Medicines Agency, 2022, MED HUM US EV
[6]  
Goyal L, 2022, J CLIN ONCOL, V40
[7]  
Goyal L, 2021, CANCER RES, V81
[8]   TAS-120 Overcomes Resistance to ATP-Compartitive FGFR Inhibitors in Patients with FGFR2 Fusion-Positive Intrahepatic Cholanjiocarcinoma [J].
Goyal, Lipika ;
Shi, Lei ;
Liu, Leah Y. ;
de la Cruz, Ferran Fece ;
Lennerz, Jochen K. ;
Raghavan, Srivatsan ;
Leschiner, Ignaty ;
Elagina, Liudmila ;
Siravegna, Giulia ;
Ng, Raymond W. S. ;
Phuong Vu ;
Patra, Krushna C. ;
Saha, Supriya K. ;
Uppot, Raul N. ;
Arellano, Ron ;
Reyes, Stephanie ;
Sagara, Takeshi ;
Otsuki, Sachie ;
Nadres, Brandon ;
Shahzade, Heather A. ;
DeyGuha, Ipsita ;
Fetter, Isobel J. ;
Baiev, Islam ;
Van Seventer, Emily E. ;
Murphy, Janet E. ;
Ferrone, Cristina R. ;
Tanabe, Kenneth K. ;
Deshpande, Vikram ;
Harding, James J. ;
Yaeger, Rona ;
Kelley, Robin K. ;
Bardelli, Alberto ;
Iafrate, A. John ;
Hahn, William C. ;
Benes, Cyril H. ;
Ting, David T. ;
Hirai, Hiroshi ;
Getz, Gad ;
Juric, Dejan ;
Zhu, Andrew X. ;
Corcoran, Ryan B. ;
Bardeesy, Nabeel .
CANCER DISCOVERY, 2019, 9 (08) :1064-1079
[9]   Roles of Fibroblast Growth Factor Receptors in Carcinogenesis [J].
Haugsten, Ellen Margrethe ;
Wiedlocha, Antoni ;
Olsnes, Sjur ;
Wesche, Jorgen .
MOLECULAR CANCER RESEARCH, 2010, 8 (11) :1439-1452
[10]   The FGFR Landscape in Cancer: Analysis of 4,853 Tumors by Next-Generation Sequencing [J].
Helsten, Teresa ;
Elkin, Sheryl ;
Arthur, Elisa ;
Tomson, Brett N. ;
Carter, Jennifer ;
Kurzrock, Razelle .
CLINICAL CANCER RESEARCH, 2016, 22 (01) :259-267