Literature DB >> 25187123

Idelalisib: first global approval.

Anthony Markham1.   

Abstract

Idelalisib (Zydelig(®)) is a highly specific small-molecule phosphatidylinositol-3-kinase (PI3Kδ) inhibitor that has been developed as an oral treatment for B cell haematological cancers.It has received its first approval in the US in July 2014 for the treatment of relapsed chronic lymphocytic leukaemia(CLL), relapsed follicular B-cell non-Hodgkin lymphoma(NHL) and relapsed small lymphocytic lymphoma (SLL) [corrected]. Idelalisib is under regulatory review in the EU-where it has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use-and in clinical development for CLL in Australia and Canada. This article summarizes the milestones in the development of Idelalisib leading to this first approval for relapsed CLL, NHL and SLL.

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Year:  2014        PMID： 25187123     DOI： 10.1007/s40265-014-0285-6

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


  9 in total

1.  PI3Kδ inhibitor, GS-1101 (CAL-101), attenuates pathway signaling, induces apoptosis, and overcomes signals from the microenvironment in cellular models of Hodgkin lymphoma.

Authors:  Sarah A Meadows; Francisco Vega; Adam Kashishian; Dave Johnson; Volker Diehl; Langdon L Miller; Anas Younes; Brian J Lannutti
Journal:  Blood       Date:  2011-12-30       Impact factor: 22.113

2.  Phosphatidylinositol 3-kinase-δ inhibitor CAL-101 shows promising preclinical activity in chronic lymphocytic leukemia by antagonizing intrinsic and extrinsic cellular survival signals.

Authors:  Sarah E M Herman; Amber L Gordon; Amy J Wagner; Nyla A Heerema; Weiqiang Zhao; Joseph M Flynn; Jeffrey Jones; Leslie Andritsos; Kamal D Puri; Brian J Lannutti; Neill A Giese; Xiaoli Zhang; Lai Wei; John C Byrd; Amy J Johnson
Journal:  Blood       Date:  2010-06-03       Impact factor: 22.113

3.  Idelalisib and rituximab in relapsed chronic lymphocytic leukemia.

Authors:  Richard R Furman; Jeff P Sharman; Steven E Coutre; Bruce D Cheson; John M Pagel; Peter Hillmen; Jacqueline C Barrientos; Andrew D Zelenetz; Thomas J Kipps; Ian Flinn; Paolo Ghia; Herbert Eradat; Thomas Ervin; Nicole Lamanna; Bertrand Coiffier; Andrew R Pettitt; Shuo Ma; Stephan Stilgenbauer; Paula Cramer; Maria Aiello; Dave M Johnson; Langdon L Miller; Daniel Li; Thomas M Jahn; Roger D Dansey; Michael Hallek; Susan M O'Brien
Journal:  N Engl J Med       Date:  2014-01-22       Impact factor: 91.245

4.  PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma.

Authors:  Ajay K Gopal; Brad S Kahl; Sven de Vos; Nina D Wagner-Johnston; Stephen J Schuster; Wojciech J Jurczak; Ian W Flinn; Christopher R Flowers; Peter Martin; Andreas Viardot; Kristie A Blum; Andre H Goy; Andrew J Davies; Pier Luigi Zinzani; Martin Dreyling; Dave Johnson; Langdon L Miller; Leanne Holes; Daniel Li; Roger D Dansey; Wayne R Godfrey; Gilles A Salles
Journal:  N Engl J Med       Date:  2014-01-22       Impact factor: 91.245

5.  Obinutuzumab: first global approval.

Authors:  Fiona Cameron; Paul L McCormack
Journal:  Drugs       Date:  2014-01       Impact factor: 9.546

6.  A phase 1 study of the PI3Kδ inhibitor idelalisib in patients with relapsed/refractory mantle cell lymphoma (MCL).

Authors:  Brad S Kahl; Stephen E Spurgeon; Richard R Furman; Ian W Flinn; Steven E Coutre; Jennifer R Brown; Don M Benson; John C Byrd; Sissy Peterman; Yoonjin Cho; Albert Yu; Wayne R Godfrey; Nina D Wagner-Johnston
Journal:  Blood       Date:  2014-03-10       Impact factor: 22.113

7.  Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110δ, for relapsed/refractory chronic lymphocytic leukemia.

Authors:  Jennifer R Brown; John C Byrd; Steven E Coutre; Don M Benson; Ian W Flinn; Nina D Wagner-Johnston; Stephen E Spurgeon; Brad S Kahl; Celeste Bello; Heather K Webb; Dave M Johnson; Sissy Peterman; Daniel Li; Thomas M Jahn; Brian J Lannutti; Roger G Ulrich; Albert S Yu; Langdon L Miller; Richard R Furman
Journal:  Blood       Date:  2014-03-10       Impact factor: 22.113

8.  Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-δ, as therapy for previously treated indolent non-Hodgkin lymphoma.

Authors:  Ian W Flinn; Brad S Kahl; John P Leonard; Richard R Furman; Jennifer R Brown; John C Byrd; Nina D Wagner-Johnston; Steve E Coutre; Don M Benson; Sissy Peterman; Yoonjin Cho; Heather K Webb; David M Johnson; Albert S Yu; Roger G Ulrich; Wayne R Godfrey; Langdon L Miller; Stephen E Spurgeon
Journal:  Blood       Date:  2014-03-10       Impact factor: 22.113

Review 9.  Ibrutinib: first global approval.

Authors:  Fiona Cameron; Mark Sanford
Journal:  Drugs       Date:  2014-02       Impact factor: 9.546
  9 in total
  19 in total

Review 1.  Pharmacokinetic and Pharmacodynamic Considerations in the Treatment of Chronic Lymphocytic Leukemia: Ibrutinib, Idelalisib, and Venetoclax.

Authors:  Madeline Waldron; Allison Winter; Brian T Hill
Journal:  Clin Pharmacokinet       Date:  2017-11       Impact factor: 6.447

2.  INCB050465 (Parsaclisib), a Novel Next-Generation Inhibitor of Phosphoinositide 3-Kinase Delta (PI3Kδ).

Authors:  Eddy W Yue; Yun-Long Li; Brent Douty; Chunhong He; Song Mei; Brian Wayland; Thomas Maduskuie; Nikoo Falahatpisheh; Richard B Sparks; Padmaja Polam; Wenyu Zhu; Joseph Glenn; Hao Feng; Ke Zhang; Yanlong Li; Xin He; Kamna Katiyar; Maryanne Covington; Patricia Feldman; Niu Shin; Kathy He Wang; Sharon Diamond; Yu Li; Holly K Koblish; Leslie Hall; Peggy Scherle; Swamy Yeleswaram; Chu-Biao Xue; Brian Metcalf; Andrew P Combs; Wenqing Yao
Journal:  ACS Med Chem Lett       Date:  2019-10-17       Impact factor: 4.345

Review 3.  Targeting mTOR signaling pathways and related negative feedback loops for the treatment of acute myeloid leukemia.

Authors:  Benedito A Carneiro; Jason B Kaplan; Jessica K Altman; Francis J Giles; Leonidas C Platanias
Journal:  Cancer Biol Ther       Date:  2015       Impact factor: 4.742

4.  Characterization of Cutaneous Adverse Events Associated With PI3K Inhibitors in 11 Patients.

Authors:  Padmavathi V Karri; Benjamin D Freemyer; Omar Pacha; Anisha B Patel
Journal:  J Immunother Precis Oncol       Date:  2020-11-12

5.  The Dual Syk/JAK Inhibitor Cerdulatinib Antagonizes B-cell Receptor and Microenvironmental Signaling in Chronic Lymphocytic Leukemia.

Authors:  Matthew D Blunt; Stefan Koehrer; Rachel C Dobson; Marta Larrayoz; Sarah Wilmore; Alice Hayman; Jack Parnell; Lindsay D Smith; Andrew Davies; Peter W M Johnson; Pamela B Conley; Anjali Pandey; Jonathan C Strefford; Freda K Stevenson; Graham Packham; Francesco Forconi; Greg P Coffey; Jan A Burger; Andrew J Steele
Journal:  Clin Cancer Res       Date:  2016-10-03       Impact factor: 12.531

Review 6.  Precision medicine for cancer with next-generation functional diagnostics.

Authors:  Adam A Friedman; Anthony Letai; David E Fisher; Keith T Flaherty
Journal:  Nat Rev Cancer       Date:  2015-11-05       Impact factor: 60.716

Review 7.  The emerging relationship between metabolism and DNA repair.

Authors:  Danilo Cucchi; Amy Gibson; Sarah A Martin
Journal:  Cell Cycle       Date:  2021-04-20       Impact factor: 4.534

8.  Introduction of pyrrolidineoxy or piperidineamino group at the 4-position of quinazoline leading to novel quinazoline-based phosphoinositide 3-kinase delta (PI3Kδ) inhibitors.

Authors:  Minhang Xin; Weiming Duan; Yifan Feng; Yuan-Yuan Hei; Hao Zhang; Ying Shen; Hong-Yi Zhao; Shuai Mao; San-Qi Zhang
Journal:  J Enzyme Inhib Med Chem       Date:  2018-12       Impact factor: 5.051

9.  Idelalisib therapy of indolent B-cell malignancies: chronic lymphocytic leukemia and small lymphocytic or follicular lymphomas.

Authors:  Yazan F Madanat; Mitchell R Smith; Alexandru Almasan; Brian T Hill
Journal:  Blood Lymphat Cancer       Date:  2016-03-15

10.  Discovery and SAR of Novel 2,3-Dihydroimidazo[1,2-c]quinazoline PI3K Inhibitors: Identification of Copanlisib (BAY 80-6946).

Authors:  William J Scott; Martin F Hentemann; R Bruce Rowley; Cathy O Bull; Susan Jenkins; Ann M Bullion; Jeffrey Johnson; Anikó Redman; Arthur H Robbins; William Esler; R Paul Fracasso; Timothy Garrison; Mark Hamilton; Martin Michels; Jill E Wood; Dean P Wilkie; Hong Xiao; Joan Levy; Enrico Stasik; Ningshu Liu; Martina Schaefer; Michael Brands; Julien Lefranc
Journal:  ChemMedChem       Date:  2016-06-16       Impact factor: 3.466
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