Literature DB >> 29626324

Apalutamide: First Global Approval.

Zaina T Al-Salama1.   

Abstract

Apalutamide (ErleadaTM) is a next-generation oral androgen receptor (AR) inhibitor that is being developed by Janssen for the treatment of prostate cancer (PC). It binds directly to the ligand-binding domain of the AR and blocks the effects of androgens. In February 2018, apalutamide received its first global approval in the USA for the treatment of non-metastatic castration-resistant PC (nmCRPC). Apalutamide is undergoing phase III investigation in chemotherapy-naive patients with metastatic CRPC (in combination with abiraterone acetate plus prednisone), patients with high-risk localized or locally advanced PC receiving primary radiation therapy, and in patients with metastatic hormone-sensitive PC and biochemically-relapsed PC. This article summarizes the milestones in the development of apalutamide leading to this first approval in nmCRPC.

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Year:  2018        PMID： 29626324     DOI： 10.1007/s40265-018-0900-z

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


  10 in total

1.  Safety and Antitumor Activity of Apalutamide (ARN-509) in Metastatic Castration-Resistant Prostate Cancer with and without Prior Abiraterone Acetate and Prednisone.

Authors:  Dana E Rathkopf; Emmanuel S Antonarakis; Neal D Shore; Ronald F Tutrone; Joshi J Alumkal; Charles J Ryan; Mansoor Saleh; Ralph J Hauke; Rajesh Bandekar; Edna Chow Maneval; Carla J de Boer; Margaret K Yu; Howard I Scher
Journal:  Clin Cancer Res       Date:  2017-02-17       Impact factor: 12.531

2.  ARN-509: a novel antiandrogen for prostate cancer treatment.

Authors:  Nicola J Clegg; John Wongvipat; James D Joseph; Chris Tran; Samedy Ouk; Anna Dilhas; Yu Chen; Kate Grillot; Eric D Bischoff; Ling Cai; Anna Aparicio; Steven Dorow; Vivek Arora; Gang Shao; Jing Qian; Hong Zhao; Guangbin Yang; Chunyan Cao; John Sensintaffar; Teresa Wasielewska; Mark R Herbert; Celine Bonnefous; Beatrice Darimont; Howard I Scher; Peter Smith-Jones; Mark Klang; Nicholas D Smith; Elisa De Stanchina; Nian Wu; Ouathek Ouerfelli; Peter J Rix; Richard A Heyman; Michael E Jung; Charles L Sawyers; Jeffrey H Hager
Journal:  Cancer Res       Date:  2012-01-20       Impact factor: 12.701

3.  Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.

Authors:  Matthew R Smith; Fred Saad; Simon Chowdhury; Stéphane Oudard; Boris A Hadaschik; Julie N Graff; David Olmos; Paul N Mainwaring; Ji Youl Lee; Hiroji Uemura; Angela Lopez-Gitlitz; Géralyn C Trudel; Byron M Espina; Youyi Shu; Youn C Park; Wayne R Rackoff; Margaret K Yu; Eric J Small
Journal:  N Engl J Med       Date:  2018-02-08       Impact factor: 91.245

4.  Phase I study of ARN-509, a novel antiandrogen, in the treatment of castration-resistant prostate cancer.

Authors:  Dana E Rathkopf; Michael J Morris; Josef J Fox; Daniel C Danila; Susan F Slovin; Jeffrey H Hager; Peter J Rix; Edna Chow Maneval; Isan Chen; Mithat Gönen; Martin Fleisher; Steven M Larson; Charles L Sawyers; Howard I Scher
Journal:  J Clin Oncol       Date:  2013-09-03       Impact factor: 44.544

Review 5.  Non-metastatic castrate-resistant prostate cancer: a call for improved guidance on clinical management.

Authors:  Francois Rozet; Thierry Roumeguère; Martin Spahn; Dirk Beyersdorff; Peter Hammerer
Journal:  World J Urol       Date:  2016-03-17       Impact factor: 4.226

Review 6.  Nonmetastatic Castration-resistant Prostate Cancer: A Modern Perspective.

Authors:  Madeline Cancian; Joseph F Renzulli
Journal:  Urology       Date:  2018-01-31       Impact factor: 2.649

7.  A clinically relevant androgen receptor mutation confers resistance to second-generation antiandrogens enzalutamide and ARN-509.

Authors:  James D Joseph; Nhin Lu; Jing Qian; John Sensintaffar; Gang Shao; Dan Brigham; Michael Moon; Edna Chow Maneval; Isan Chen; Beatrice Darimont; Jeffrey H Hager
Journal:  Cancer Discov       Date:  2013-06-18       Impact factor: 39.397

8.  Comparison of the effect of the antiandrogen apalutamide (ARN-509) versus bicalutamide on the androgen receptor pathway in prostate cancer cell lines.

Authors:  Michael I Koukourakis; Christos Kakouratos; Dimitra Kalamida; Achilleas Mitrakas; Stamatia Pouliliou; Erasmia Xanthopoulou; Evdokia Papadopoulou; Virginia Fasoulaki; Alexandra Giatromanolaki
Journal:  Anticancer Drugs       Date:  2018-04       Impact factor: 2.248

9.  Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist, in the High-risk Nonmetastatic Castration-resistant Prostate Cancer Cohort.

Authors:  Matthew R Smith; Emmanuel S Antonarakis; Charles J Ryan; William R Berry; Neal D Shore; Glenn Liu; Joshi J Alumkal; Celestia S Higano; Edna Chow Maneval; Rajesh Bandekar; Carla J de Boer; Margaret K Yu; Dana E Rathkopf
Journal:  Eur Urol       Date:  2016-05-06       Impact factor: 20.096

10.  Androgen receptor mutations in patients with castration-resistant prostate cancer treated with apalutamide.

Authors:  D E Rathkopf; M R Smith; C J Ryan; W R Berry; N D Shore; G Liu; C S Higano; J J Alumkal; R Hauke; R F Tutrone; M Saleh; E Chow Maneval; S Thomas; D S Ricci; M K Yu; C J de Boer; A Trinh; T Kheoh; R Bandekar; H I Scher; E S Antonarakis
Journal:  Ann Oncol       Date:  2017-09-01       Impact factor: 32.976
  10 in total
  10 in total

Review 1.  Therapy of Advanced Prostate Cancer: Targeting the Androgen Receptor Axis in Earlier Lines of Treatment.

Authors:  Harsh Shah; Ulka Vaishampayan
Journal:  Target Oncol       Date:  2018-12       Impact factor: 4.493

Review 2.  Timing of androgen deprivation monotherapy and combined treatments in castration-sensitive and castration-resistant prostate cancer: a narrative review.

Authors:  F Kunath; P J Goebell; B Wullich; D Sikic; A Kahlmeyer
Journal:  World J Urol       Date:  2019-03-04       Impact factor: 4.226

Review 3.  Therapies Targeted to Androgen Receptor Signaling Axis in Prostate Cancer: Progress, Challenges, and Hope.

Authors:  Sirin Saranyutanon; Sanjeev Kumar Srivastava; Sachin Pai; Seema Singh; Ajay Pratap Singh
Journal:  Cancers (Basel)       Date:  2019-12-23       Impact factor: 6.639

Review 4.  Previous, Current, and Future Pharmacotherapy and Diagnosis of Prostate Cancer-A Comprehensive Review.

Authors:  Bartosz Malinowski; Michał Wiciński; Nikola Musiała; Ilona Osowska; Mateusz Szostak
Journal:  Diagnostics (Basel)       Date:  2019-10-25

5.  Patient and caregiver benefit-risk preferences for nonmetastatic castration-resistant prostate cancer treatment.

Authors:  Sandy Srinivas; Ateesha F Mohamed; Sreevalsa Appukkuttan; Marc Botteman; Xinyi Ng; Namita Joshi; Jui-Hua Tsai; Jarjieh Fang; A Reginald Waldeck; Stacey J Simmons
Journal:  Cancer Med       Date:  2020-07-29       Impact factor: 4.452

Review 6.  Gonadotropin-Releasing Hormone Receptors in Prostate Cancer: Molecular Aspects and Biological Functions.

Authors:  Fabrizio Fontana; Monica Marzagalli; Marina Montagnani Marelli; Michela Raimondi; Roberta M Moretti; Patrizia Limonta
Journal:  Int J Mol Sci       Date:  2020-12-14       Impact factor: 5.923

Review 7.  FDA-Approved Small Molecule Compounds as Drugs for Solid Cancers from Early 2011 to the End of 2021.

Authors:  Aleksandra Sochacka-Ćwikła; Marcin Mączyński; Andrzej Regiec
Journal:  Molecules       Date:  2022-03-31       Impact factor: 4.411

8.  HC-1119, a deuterated Enzalutamide, inhibits Migration, Invasion and Metastasis of the AR-positive triple-negative breast Cancer cells.

Authors:  Xuehong Wu; Wanru Feng; Mao Yang; Xunxi Liu; Mengdi Gao; Xinghai Li; Lin Gan; Tao He
Journal:  Mol Biol Rep       Date:  2022-08-12       Impact factor: 2.742

9.  Apalutamide: A novel therapy for non metastatic castration-resistant carcinoma prostate.

Authors:  Sudhindra Jayasimha
Journal:  Indian J Urol       Date:  2018 Oct-Dec

10.  Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial.

Authors:  Byung Ha Chung; Jian Huang; Zhang-Qun Ye; Da-Lin He; Hirotsugu Uemura; Gaku Arai; Choung Soo Kim; Yuan-Yuan Zhang; Yusoke Koroki; SuYeon Jeong; Suneel Mundle; Spyros Triantos; Sharon McCarthy; Kim N Chi; Ding-Wei Ye
Journal:  Asian J Androl       Date:  2022 Mar-Apr       Impact factor: 3.285
  10 in total

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