Literature DB >> 28612232

Midostaurin: First Global Approval.

Esther S Kim1.   

Abstract

Midostaurin (Rydapt®) is a multikinase inhibitor being developed by Novartis Pharmaceuticals. In April 2017, midostaurin was approved in the USA for the treatment of adult patients with newly diagnosed, FMS-like tyrosine kinase 3 (FLT3) mutation-positive acute myeloid leukaemia (AML) [in combination with standard cytarabine and daunorubicin induction, and cytarabine consolidation], or aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL) [collectively known as advanced SM]. The article summarizes the milestones in the development of midostaurin leading to this first global approval.

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Year:  2017        PMID： 28612232     DOI： 10.1007/s40265-017-0779-0

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  12 in total

1.  Hematopoietic stem-cell transplantation for advanced systemic mastocytosis.

Authors:  Celalettin Ustun; Andreas Reiter; Bart L Scott; Ryotaro Nakamura; Gandhi Damaj; Sebastian Kreil; Ryan Shanley; William J Hogan; Miguel-Angel Perales; Tsiporah Shore; Herrad Baurmann; Robert Stuart; Bernd Gruhn; Michael Doubek; Jack W Hsu; Eleni Tholouli; Tanja Gromke; Lucy A Godley; Livio Pagano; Andrew Gilman; Eva Maria Wagner; Tor Shwayder; Martin Bornhäuser; Esperanza B Papadopoulos; Alexandra Böhm; Gregory Vercellotti; Maria Teresa Van Lint; Christoph Schmid; Werner Rabitsch; Vinod Pullarkat; Faezeh Legrand; Ibrahim Yakoub-Agha; Wael Saber; John Barrett; Olivier Hermine; Hans Hagglund; Wolfgang R Sperr; Uday Popat; Edwin P Alyea; Steven Devine; H Joachim Deeg; Daniel Weisdorf; Cem Akin; Peter Valent
Journal:  J Clin Oncol       Date:  2014-08-25       Impact factor: 44.544

2.  Efficacy and Safety of Midostaurin in Advanced Systemic Mastocytosis.

Authors:  Jason Gotlib; Hanneke C Kluin-Nelemans; Tracy I George; Cem Akin; Karl Sotlar; Olivier Hermine; Farrukh T Awan; Elizabeth Hexner; Michael J Mauro; David W Sternberg; Matthieu Villeneuve; Alice Huntsman Labed; Eric J Stanek; Karin Hartmann; Hans-Peter Horny; Peter Valent; Andreas Reiter
Journal:  N Engl J Med       Date:  2016-06-30       Impact factor: 91.245

3.  Phase IB study of the FLT3 kinase inhibitor midostaurin with chemotherapy in younger newly diagnosed adult patients with acute myeloid leukemia.

Authors:  R M Stone; T Fischer; R Paquette; G Schiller; C A Schiffer; G Ehninger; J Cortes; H M Kantarjian; D J DeAngelo; A Huntsman-Labed; C Dutreix; A del Corral; F Giles
Journal:  Leukemia       Date:  2012-04-27       Impact factor: 11.528

4.  Preclinical and phase I results of decitabine in combination with midostaurin (PKC412) for newly diagnosed elderly or relapsed/refractory adult patients with acute myeloid leukemia.

Authors:  Casey B Williams; Suman Kambhampati; Warren Fiskus; Jo Wick; Catherine Dutreix; Siddartha Ganguly; Omar Aljitawi; Ruben Reyes; Allan Fleming; Sunil Abhyankar; Kapil N Bhalla; Joseph P McGuirk
Journal:  Pharmacotherapy       Date:  2013-06-24       Impact factor: 4.705

5.  Phase I/II trial of the combination of midostaurin (PKC412) and 5-azacytidine for patients with acute myeloid leukemia and myelodysplastic syndrome.

Authors:  Paolo Strati; Hagop Kantarjian; Farhad Ravandi; Aziz Nazha; Gautam Borthakur; Naval Daver; Tapan Kadia; Zeev Estrov; Guillermo Garcia-Manero; Marina Konopleva; Trivikram Rajkhowa; Menda Durand; Michael Andreeff; Mark Levis; Jorge Cortes
Journal:  Am J Hematol       Date:  2015-03-02       Impact factor: 10.047

6.  A phase I study of midostaurin and azacitidine in relapsed and elderly AML patients.

Authors:  Brenda W Cooper; Tamila L Kindwall-Keller; Michael D Craig; Richard J Creger; Mehdi Hamadani; William W Tse; Hillard M Lazarus
Journal:  Clin Lymphoma Myeloma Leuk       Date:  2015-02-16

7.  Inhibition of mutant FLT3 receptors in leukemia cells by the small molecule tyrosine kinase inhibitor PKC412.

Authors:  Ellen Weisberg; Christina Boulton; Louise M Kelly; Paul Manley; Doriano Fabbro; Thomas Meyer; D Gary Gilliland; James D Griffin
Journal:  Cancer Cell       Date:  2002-06       Impact factor: 31.743

8.  Patients with acute myeloid leukemia and an activating mutation in FLT3 respond to a small-molecule FLT3 tyrosine kinase inhibitor, PKC412.

Authors:  Richard M Stone; Daniel J DeAngelo; Virginia Klimek; Ilene Galinsky; Eli Estey; Stephen D Nimer; Wilson Grandin; David Lebwohl; Yanfeng Wang; Pamela Cohen; Edward A Fox; Donna Neuberg; Jennifer Clark; D Gary Gilliland; James D Griffin
Journal:  Blood       Date:  2004-09-02       Impact factor: 22.113

Review 9.  An update of current treatments for adult acute myeloid leukemia.

Authors:  Hervé Dombret; Claude Gardin
Journal:  Blood       Date:  2015-12-10       Impact factor: 22.113

10.  Target interaction profiling of midostaurin and its metabolites in neoplastic mast cells predicts distinct effects on activation and growth.

Authors:  B Peter; G E Winter; K Blatt; K L Bennett; G Stefanzl; U Rix; G Eisenwort; E Hadzijusufovic; M Gridling; C Dutreix; G Hoermann; J Schwaab; D Radia; J Roesel; P W Manley; A Reiter; G Superti-Furga; P Valent
Journal:  Leukemia       Date:  2015-09-09       Impact factor: 11.528
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  15 in total

Review 1.  Targeting multiple signaling pathways: the new approach to acute myeloid leukemia therapy.

Authors:  Jenna L Carter; Katie Hege; Jay Yang; Hasini A Kalpage; Yongwei Su; Holly Edwards; Maik Hüttemann; Jeffrey W Taub; Yubin Ge
Journal:  Signal Transduct Target Ther       Date:  2020-12-18

2.  Comparative efficacy and safety of eleven induction chemotherapy regimens for young adult patients with newly diagnosed acute myeloid leukemia: a network meta-analysis.

Authors:  Yiqing Li; Ting Tang; Jie Xiao; Boqi Li; Wenjuan Yang; Shuangfeng Xie; Yumo Du; Kezhi Huang; Danian Nie
Journal:  Ann Hematol       Date:  2022-04-20       Impact factor: 3.673

3.  New developments in the field of mastocytosis and mast cell activation syndromes: a summary of the Annual Meeting of the European Competence Network on Mastocytosis (ECNM) 2019.

Authors:  Michel Arock; Karl Sotlar; Jason Gotlib; Wolfgang R Sperr; Karin Hartmann; Lawrence B Schwartz; Cem Akin; Hans-Peter Horny; Peter Valent
Journal:  Leuk Lymphoma       Date:  2019-12-26

4.  Potential for subsets of wt-NPM1 primary AML blasts to respond to retinoic acid treatment.

Authors:  Rodica P Bunaciu; Robert J MacDonald; Feng Gao; Lynn M Johnson; Jeffrey D Varner; Xin Wang; Sarah Nataraj; Monica L Guzman; Andrew Yen
Journal:  Oncotarget       Date:  2017-12-23

5.  Midostaurin potentiates rituximab antitumor activity in Burkitt's lymphoma by inducing apoptosis.

Authors:  Xiaowen Ge; Jianfeng Chen; Ling Li; Peipei Ding; Qi Wang; Wei Zhang; Luying Li; Xinyue Lv; Danlei Zhou; Zhengzeng Jiang; Haiying Zeng; Yifan Xu; Yingyong Hou; Weiguo Hu
Journal:  Cell Death Dis       Date:  2018-12-18       Impact factor: 8.469

6.  Midostaurin In Acute Myeloid Leukemia: An Evidence-Based Review And Patient Selection.

Authors:  Hussein A Abbas; Mansour Alfayez; Tapan Kadia; Farhad Ravandi-Kashani; Naval Daver
Journal:  Cancer Manag Res       Date:  2019-10-04       Impact factor: 3.989

7.  Kinase-Based Screening of Marine Natural Extracts Leads to the Identification of a Cytotoxic High Molecular Weight Metabolite from the Mediterranean Sponge Crambe tailliezi.

Authors:  Thi-Ngoc-Dung Nguyen; Omid Feizbakhsh; Estelle Sfecci; Blandine Baratte; Claire Delehouzé; Adrien Garcia; Corentin Moulin; Pierre Colas; Sandrine Ruchaud; Mohamed Mehiri; Stéphane Bach
Journal:  Mar Drugs       Date:  2019-10-09       Impact factor: 5.118

Review 8.  Protein Tyrosine Kinases: Their Roles and Their Targeting in Leukemia.

Authors:  Kalpana K Bhanumathy; Amrutha Balagopal; Frederick S Vizeacoumar; Franco J Vizeacoumar; Andrew Freywald; Vincenzo Giambra
Journal:  Cancers (Basel)       Date:  2021-01-07       Impact factor: 6.639

Review 9.  Marine Anticancer Agents: An Overview with a Particular Focus on Their Chemical Classes.

Authors:  Marilia Barreca; Virginia Spanò; Alessandra Montalbano; Mercedes Cueto; Ana R Díaz Marrero; Irem Deniz; Ayşegül Erdoğan; Lada Lukić Bilela; Corentin Moulin; Elisabeth Taffin-de-Givenchy; Filippo Spriano; Giuseppe Perale; Mohamed Mehiri; Ana Rotter; Olivier P Thomas; Paola Barraja; Susana P Gaudêncio; Francesco Bertoni
Journal:  Mar Drugs       Date:  2020-12-04       Impact factor: 5.118

10.  Cost Effectiveness of Midostaurin in the Treatment of Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia in the United States.

Authors:  Eytan Stein; Jipan Xie; Emilie Duchesneau; Subrata Bhattacharyya; Umakanth Vudumula; Briana Ndife; Gaetano Bonifacio; Annie Guerin; Nanxin Li; George Joseph
Journal:  Pharmacoeconomics       Date:  2019-02       Impact factor: 4.558
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