Literature DB >> 30430368

Duvelisib: First Global Approval.

Hannah A Blair1.   

Abstract

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.

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Year:  2018        PMID: 30430368     DOI: 10.1007/s40265-018-1013-4

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


  7 in total

1.  PI3K-δ and PI3K-γ inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models.

Authors:  David G Winkler; Kerrie L Faia; Jonathan P DiNitto; Janid A Ali; Kerry F White; Erin E Brophy; Melissa M Pink; Jennifer L Proctor; Jennifer Lussier; Christian M Martin; Jennifer G Hoyt; Bonnie Tillotson; Erin L Murphy; Alice R Lim; Brian D Thomas; John R Macdougall; Pingda Ren; Yi Liu; Lian-Sheng Li; Katti A Jessen; Christian C Fritz; Joi L Dunbar; James R Porter; Christian Rommel; Vito J Palombella; Paul S Changelian; Jeffery L Kutok
Journal:  Chem Biol       Date:  2013-11-07

2.  IPI-145 antagonizes intrinsic and extrinsic survival signals in chronic lymphocytic leukemia cells.

Authors:  Shuai Dong; Daphne Guinn; Jason A Dubovsky; Yiming Zhong; Amy Lehman; Jeffery Kutok; Jennifer A Woyach; John C Byrd; Amy J Johnson
Journal:  Blood       Date:  2014-09-25       Impact factor: 22.113

3.  Activity of the PI3K-δ,γ inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma.

Authors:  Steven M Horwitz; Raphael Koch; Pierluigi Porcu; Yasuhiro Oki; Alison Moskowitz; Megan Perez; Patricia Myskowski; Adam Officer; Jacob D Jaffe; Sara N Morrow; Kerstin Allen; Mark Douglas; Howard Stern; Jennifer Sweeney; Patrick Kelly; Virginia Kelly; Jon C Aster; David Weaver; Francine M Foss; David M Weinstock
Journal:  Blood       Date:  2017-12-12       Impact factor: 22.113

Review 4.  Duvelisib: a phosphoinositide-3 kinase δ/γ inhibitor for chronic lymphocytic leukemia.

Authors:  Hima V Vangapandu; Nitin Jain; Varsha Gandhi
Journal:  Expert Opin Investig Drugs       Date:  2017-04-13       Impact factor: 6.206

5.  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.

Authors:  K Balakrishnan; M Peluso; M Fu; N Y Rosin; J A Burger; W G Wierda; M J Keating; K Faia; S O'Brien; J L Kutok; V Gandhi
Journal:  Leukemia       Date:  2015-04-28       Impact factor: 11.528

6.  The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL.

Authors:  Ian W Flinn; Peter Hillmen; Marco Montillo; Zsolt Nagy; Árpád Illés; Gabriel Etienne; Julio Delgado; Bryone J Kuss; Constantine S Tam; Zoltán Gasztonyi; Fritz Offner; Scott Lunin; Francesco Bosch; Matthew S Davids; Nicole Lamanna; Ulrich Jaeger; Paolo Ghia; Florence Cymbalista; Craig A Portell; Alan P Skarbnik; Amanda F Cashen; David T Weaver; Virginia M Kelly; Barry Turnbull; Stephan Stilgenbauer
Journal:  Blood       Date:  2018-10-04       Impact factor: 22.113

7.  Duvelisib, a novel oral dual inhibitor of PI3K-δ,γ, is clinically active in advanced hematologic malignancies.

Authors:  Ian W Flinn; Susan O'Brien; Brad Kahl; Manish Patel; Yasuhiro Oki; Francine F Foss; Pierluigi Porcu; Jeffrey Jones; Jan A Burger; Nitin Jain; Virginia M Kelly; Kerstin Allen; Mark Douglas; Jennifer Sweeney; Patrick Kelly; Steven Horwitz
Journal:  Blood       Date:  2017-11-30       Impact factor: 22.113

  7 in total
  21 in total

Review 1.  Targeted Therapy in Chronic Lymphocytic Leukemia.

Authors:  Thomas J Kipps; Michael Y Choi
Journal:  Cancer J       Date:  2019 Nov/Dec       Impact factor: 3.360

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.  Targeted Drug Delivery for Chronic Lymphocytic Leukemia.

Authors:  Makhloufi Zoulikha; Wei He
Journal:  Pharm Res       Date:  2022-03-07       Impact factor: 4.200

4.  An Innovation 10 Years in the Making: The Stories in the Pages of ACS Medicinal Chemistry Letters.

Authors:  Ryan A Altman; Annalaura Brai; Jennifer Golden; Giuseppe La Regina; Zhengqiu Li; Terry W Moore; William C K Pomerantz; Naomi S Rajapaksa; Ashley M Adams
Journal:  ACS Med Chem Lett       Date:  2022-02-03       Impact factor: 4.632

Review 5.  PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.

Authors:  Rosalin Mishra; Hima Patel; Samar Alanazi; Mary Kate Kilroy; Joan T Garrett
Journal:  Int J Mol Sci       Date:  2021-03-27       Impact factor: 5.923

Review 6.  The role of PI3Kγ in the immune system: new insights and translational implications.

Authors:  Stephen M Lanahan; Matthias P Wymann; Carrie L Lucas
Journal:  Nat Rev Immunol       Date:  2022-03-23       Impact factor: 53.106

7.  Dual PI3Kδ/γ Inhibitor Duvelisib Prevents Development of Neuropathic Pain in Model of Paclitaxel-Induced Peripheral Neuropathy.

Authors:  Pavel Adamek; Mario Heles; Anirban Bhattacharyya; Monica Pontearso; Jakub Slepicka; Jiri Palecek
Journal:  J Neurosci       Date:  2022-01-18       Impact factor: 6.709

Review 8.  CAM-DR: Mechanisms, Roles and Clinical Application in Tumors.

Authors:  Yuejiao Huang; Yuchan Wang; Jie Tang; Shiyi Qin; Xianjuan Shen; Song He; Shaoqing Ju
Journal:  Front Cell Dev Biol       Date:  2021-07-06

9.  A Highly Sensitive Nonextraction-Assisted HPLC Method with Fluorescence Detection for Quantification of Duvelisib in Plasma Samples and its Application to Pharmacokinetic Study in Rats.

Authors:  Ahmed Y Sayed; Nasr Y Khalil; Aliyah Almomen; Nourah Z Alzoman; Abdulrahman A Almehizia; Ibrahim A Darwish
Journal:  Drug Des Devel Ther       Date:  2021-06-21       Impact factor: 4.162

Review 10.  Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.

Authors:  Ningni Jiang; Qijie Dai; Xiaorui Su; Jianjiang Fu; Xuancheng Feng; Juan Peng
Journal:  Mol Biol Rep       Date:  2020-04-24       Impact factor: 2.742

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