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EP About this file: EP3609497

EP3609497 - NIRAPARIB, ABIRATERONE ACETATE AND PREDNISONE FOR TREATING PROSTATE CANCER [Right-click to bookmark this link]
Former [2020/08]	COMBINATION THERAPY FOR PROSTATE CANCER
	[2022/32]
Status	The patent has been granted Status updated on 09.09.2022 Database last updated on 15.06.2024
Former	Grant of patent is intended Status updated on 22.07.2022
Former	Request for examination was made Status updated on 17.01.2020
Former	The international publication has been made Status updated on 20.10.2018
Former	unknown Status updated on 11.05.2018
Most recent event Tooltip	07.05.2024	New entry: Date of oral proceedings
Applicant(s)	For all designated states Janssen Pharmaceutica NV Turnhoutseweg 30 2340 Beerse / BE
	[2020/08]
Inventor(s)	01 / YU, Margaret K. 10990 Wilshire Blvd., Suite 300 Los Angeles, California 90024 / US
	02 / SNYDER, Linda Anne 1400 McKean Road Spring House, Pennsylvania 19477 / US
	[2022/41]
Former [2020/08]	01 / YU, Margaret K. 10990 Wilshire Blvd., Suite 300 Los Angeles, California 90024 / US
	02 / SNYDER, Linda Anne 1400 McKean Road Spring House, Pennsylvania 19477 / US
	03 / SNYDER, Linda Anne 1400 McKean Road Spring House, Pennsylvania 19477 / US
Representative(s)	Carpmaels & Ransford LLP One Southampton Row London WC1B 5HA / GB
	[2022/41]
Former [2020/08]	Oates, Edward Christopher Carpmaels & Ransford LLP One Southampton Row London WC1B 5HA / GB
Application number, filing date	18720895.4	09.04.2018
	[2020/08]
	WO2018US26661
Priority number, date	US201762485164P	13.04.2017 Original published format: US 201762485164 P
	[2020/08]
Filing language	EN
Procedural language	EN
Publication	Type:	A1 Application with search report
	No.:	WO2018191141
	Date:	18.10.2018
	Language:	EN
	[2018/42]
	Type:	A1 Application with search report
	No.:	EP3609497
	Date:	19.02.2020
	Language:	EN
	The application published by WIPO in one of the EPO official languages on 18.10.2018 takes the place of the publication of the European patent application.
	[2020/08]
	Type:	B1 Patent specification
	No.:	EP3609497
	Date:	12.10.2022
	Language:	EN
	[2022/41]
Search report(s)	International search report - published on:	EP	18.10.2018
Classification	IPC:	A61K31/454, A61K31/573, A61K31/58, A61P35/00	[2020/08]
	CPC:	A61K31/58 (EP,EA,KR,US); A61K31/454 (EP,EA,KR,US); A61K31/573 (EP,EA,KR,US); A61K45/06 (EP); A61P35/00 (EP,EA,KR,US); A61K2300/00 (KR)
	C-Set:	A61K31/454, A61K2300/00 (EP,US); A61K31/573, A61K2300/00 (US,EP); A61K31/58, A61K2300/00 (US,EP)
Designated contracting states	AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR [2020/08]
Extension states	BA	13.11.2019
	ME	13.11.2019
Validation states	KH	13.11.2019
	MA	13.11.2019
	MD	13.11.2019
	TN	13.11.2019
Title	German:	NIRAPARIB, ABIRATERONACETAT UND PREDNISON ZUR BEHANDLUNG VON PROSTATAKREBS	[2022/32]
	English:	NIRAPARIB, ABIRATERONE ACETATE AND PREDNISONE FOR TREATING PROSTATE CANCER	[2022/32]
	French:	NIRAPARIB, ACÉTATE D'ABIRATÉRONE ET PREDNISONE POUR LE TRAITEMENT DU CANCER DE LA PROSTATE	[2022/32]
	Former [2020/08]	KOMBINATIONSTHERAPIE FÜR PROSTATAKREBS
	Former [2020/08]	COMBINATION THERAPY FOR PROSTATE CANCER
	Former [2020/08]	POLYTHÉRAPIE CONTRE LE CANCER DE LA PROSTATE
Entry into regional phase	13.11.2019	National basic fee paid
	13.11.2019	Designation fee(s) paid
	13.11.2019	Examination fee paid
Examination procedure	13.11.2019	Examination requested [2020/08]
	13.11.2019	Date on which the examining division has become responsible
	06.07.2020	Despatch of communication that the application is deemed to be withdrawn, reason: reply to the Extended European Search Report/Written Opinion of the International Searching Authority/International Preliminary Examination Report/Supplementary international search report not received in time
	16.09.2020	Amendment by applicant (claims and/or description)
	22.07.2022	Communication of intention to grant the patent
	31.08.2022	Fee for grant paid
	31.08.2022	Fee for publishing/printing paid
	31.08.2022	Receipt of the translation of the claim(s)
Divisional application(s)	EP22200801.3 / EP4176878
	EP22200882.3 / EP4176879
Opposition(s)	Opponent(s)	01 06.07.2023 07.07.2023 ADMISSIBLE TEVA PHARMACEUTICAL INDUSTRIES, LTD. 124 Dvora HaNevi'a St. 6944020 Tel Aviv / IL Opponent's representative von Kauffmann, Carl Global IP Group - Teva Graf-Arco-Straße 3 89079 Ulm / DE
		02 11.07.2023 12.07.2023 ADMISSIBLE Sandoz AG Lichtstrasse 35 4056 Basel / CH Opponent's representative Elkington and Fife LLP Prospect House 8 Pembroke Road Sevenoaks, Kent TN13 1XR / GB
		03 12.07.2023 13.07.2023 ADMISSIBLE Generics [UK] Limited Building 4, Trident Place Mosquito Way Hatfield Hertfordshire AL10 9UL / GB Opponent's representative Russell, Tim Venner Shipley LLP 200 Aldersgate London EC1A 4HD / GB
		[2023/33]
	Former [2023/32]
	Opponent(s)	01 06.07.2023 TEVA PHARMACEUTICAL INDUSTRIES, LTD. 124 Dvora HaNevi'a St. 6944020 Tel Aviv / IL Opponent's representative von Kauffmann, Carl Global IP Group - Teva Graf-Arco-Straße 3 89079 Ulm / DE
	24.07.2023	Invitation to proprietor to file observations on the notice of opposition
	05.02.2024	Reply of patent proprietor to notice(s) of opposition
	05.11.2024	Date of oral proceedings
Request for further processing for:	16.09.2020	Request for further processing filed
	16.09.2020	Full payment received (date of receipt of payment) Request granted
	28.09.2020	Decision despatched
Fees paid	Renewal fee
	31.03.2020	Renewal fee patent year 03
	15.04.2021	Renewal fee patent year 04
	14.03.2022	Renewal fee patent year 05
Opt-out from the exclusive Tooltip competence of the Unified Patent Court	See the Register of the Unified Patent Court for opt-out data
	Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court.
Lapses during opposition Tooltip	AL	12.10.2022
	[2023/37]
Cited in	International search	[Y]US2014336157 (AUERBACH ALAN H [US], et al) [Y] 1-36 * claim - *;
		[XI] - Janssen research & Development, LLC, "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)", ClinicalTrials.gov, (20161005), URL: https://clinicaltrials.gov/ct2/show/NCT02924766, (20180614), XP002782025 [X] 34-36 * page 2 * [I] 1-33
		[Y] - R. J. AUCHUS ET AL, "Use of Prednisone With Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer", THE ONCOLOGIST, US, (20141031), vol. 19, no. 12, doi:10.1634/theoncologist.2014-0167, ISSN 1083-7159, pages 1231 - 1240, XP055483431 [Y] 1-36 * page 1236 * DOI: http://dx.doi.org/10.1634/theoncologist.2014-0167
		[Y] - RYAN CHARLES J ET AL, "Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study.", THE LANCET. ONCOLOGY, (201502), vol. 16, no. 2, ISSN 1474-5488, pages 152 - 160, XP002782026 [Y] 1-36 * abstract *
		[Y] - GRAS JORDI, "Niraparib hydrochloride. Poly [ADP-ribose] polymerase (PARP) inhibitor, Oncolytic", DRUGS OF THE FUTURE, PROUS SCIENCE, ES, (20131001), vol. 38, no. 10, doi:10.1358/DOF.2013.38.10.2059820, ISSN 0377-8282, pages 679 - 685, XP009195509 [Y] 1-36 * page 683 * DOI: http://dx.doi.org/10.1358/dof.2013.38.10.2059820
	by applicant	US8071623
		US8436185
		- JONES P; WILCOXEN K; ROWLEY M; TONIATTI C, "Niraparib: A Poly(ADP-ribose) Polymerase (PARP) Inhibitor for the Treatment of Tumors with Defective Homologous Recombination", J Med Chem., (20150423), vol. 58, no. 8, pages 3302 - 3314
	Opposition	US2014336157
		WO2008084261
		- Anonymous, "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) \| NCT02924766 ", ClinicalTrials.gov, (20161004), URL: https://clinicaltrials.gov/study/NCT02924766?tab=history&a=1, XP093122395
		- Anonymous, "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) \| NCT02924766 ", ClinicalTrials.gov, (20161103), URL: https://clinicaltrials.gov/study/NCT02924766?tab=history&a=2, XP093122407
		- R. J. Auchus, M. K. Yu, S. Nguyen, S. D. Mundle, "Use of Prednisone With Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer", THE ONCOLOGIST, (20141201), vol. 19, no. 12, doi:10.1634/theoncologist.2014-0167, ISSN 1083-7159, pages 1231 - 1240, XP055483431 DOI: http://dx.doi.org/10.1634/theoncologist.2014-0167
		- RYAN CHARLES J ET AL, "Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study.", The Lancet Oncology, Elsevier Ltd, (20150201), vol. 16, no. 2, ISSN 1474-5488, pages 152 - 160, XP002782026
		- Gras Jordi, "Niraparib hydrochloride. Poly [ADP-ribose] polymerase (PARP) inhibitor, Oncolytic.", Drugs of the Future, Prous Science, ES, ES , (20131001), vol. 38, no. 10, doi:10.1358/dof.2013.38.10.2059820, ISSN 0377-8282, pages 679 - 685, XP009195509 DOI: http://dx.doi.org/10.1358/dof.2013.38.10.2059820
		- Hussain Maha, Stephanie Daignault, Przemyslaw Twardowski, Costantine Albany, Mark N. Stein, Lakshmi Priya Kunju, Javed Siddiqui Et Al., "Co-targeting androgen receptor (AR) and DNA repair: A randomized ETS gene fusion-stratified trial of abiraterone + prednisone (Abi) +/- the PARP1 inhibitor veliparib for metastatic castration-resistant prostate cancer (mCRPC) patients (pts) (NCI9012)—A University of Chicago phase II consortium trial", Journal of Clinical Oncology, (20160520), vol. 34, no. 15 suppl., XP093121755
		- Jones Philip, Wilcoxen Keith, Rowley Michael, Toniatti Carlo, "Niraparib: A Poly(ADP-ribose) Polymerase (PARP) Inhibitor for the Treatment of Tumors with Defective Homologous Recombination", Journal of Medicinal Chemistry, American Chemical Society, US, US , (20150423), vol. 58, no. 8, doi:10.1021/jm5018237, ISSN 0022-2623, pages 3302 - 3314, XP055855855 DOI: http://dx.doi.org/10.1021/jm5018237
		- Sandhu S. K., V. Moreno, G. Wilding, A. Omlin, W.R. Schelman Et Al., "112. PHASE I STUDY OF A POLY(ADP)-RIBOSE POLYMERASE (PARP) INHIBITOR MK-4827 (MK) WITH ANTITUMOUR ACTIVITY IN SPORADIC CASTRATION RESISTANT PROSTATE CANCER (CRPC)", ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Poster Abstracts, (20120101), vol. 8, no. suppl. 1, page 33, XP093122422 DOI: http://dx.doi.org/10.1111/j.1743-7563.2012.01575.x
		- J Zhang null, "Poly (AADP-ribose) polymerase inhibitor: an evolving paradigm in the treatment of prostate cancer", Asian Journal of Andrology, (2014), vol. 16, doi:10.4103/1008-682X.123684, XP055472262 DOI: http://dx.doi.org/10.4103/1008-682X.123684
		- Chi Kim N, Rathkopf Dana, Smith Matthew R, Efstathiou Eleni, Attard Gerhardt, Olmos David, Ji ;, Lee Youl, Small Eric J, Pereira De Andrea J, Gomes Santana, Roubaud Guilhem, Saad Marniza, Zurawski Bogdan, Sakalo Valerii, Mason Gary E, Francis Peter, Wang George, Wu Daphne, Diorio Brooke, Lopez-Gitlitz Angela, Sandhu Shahneen, "Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer", J CLIN. ONCOLOGY, (20230323), vol. 41, doi:10.1200/JCO.22, pages 1 - 15, XP093071658 DOI: http://dx.doi.org/10.1200/JCO.22
		- Drean Amy; Lord Christopher J.; Ashworth Alan, "PARP inhibitor combination therapy", Critical Reviews in Oncology/Hematology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (19000101), vol. 108, doi:10.1016/j.critrevonc.2016.10.010, ISSN 1040-8428, pages 73 - 85, XP029827859 DOI: http://dx.doi.org/10.1016/j.critrevonc.2016.10.010
		- Jessica S. Brown, Brent O'carrigan, Stephen P. Jackson, Timothy A. Yap, "Targeting DNA Repair in Cancer: Beyond PARP Inhibitors", CANCER DISCOVERY, American Association for Cancer Research, US, US , (20170101), vol. 7, no. 1, doi:10.1158/2159-8290.CD-16-0860, ISSN 2159-8274, pages 20 - 37, XP055453319 DOI: http://dx.doi.org/10.1158/2159-8290.CD-16-0860
		- Schiewer Matthew J., Goodwin Jonathan F., Han Sumin, Brenner J. Chad, Augello Michael A., Dean Jeffry L., Liu Fengzhi, Planck Jamie L., Ravindranathan Preethi, Chinnaiyan Arul M., Mccue Peter, Gomella Leonard G., Raj Ganesh V., Dicker Adam P., Brody Jonathan R., Pascal John M., Centenera Margaret M., Butler Lisa M., Tilley Wayne D., Feng Felix Y., Knudsen Karen E., "Dual Roles of PARP-1 Promote Cancer Growth and Progression", CANCER DISCOVERY, American Association for Cancer Research, US, US , (20121201), vol. 2, no. 12, doi:10.1158/2159-8290.CD-12-0120, ISSN 2159-8274, pages 1134 - 1149, XP093122430 DOI: http://dx.doi.org/10.1158/2159-8290.CD-12-0120
		- "Chapter 12 - Initiating and Managing Therapy", Tozer Thomas N., Malcolm Rowland, Introduction to Pharmacokinetics and Pharmacodynamics - The Quantitative Basis of Drug Therapy, (20060101), pages 249 - 265, XP093122437
		- Anonymous, "Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer \| NCT01576172 ", ClinicalTrials.gov, (20161222), URL: https://clinicaltrials.gov/study/NCT01576172?tab=history&a=52, XP093122442
		- European Medicines Agency, "Assessment Report For Zytiga (abiraterone)", (20110721), pages 1 - 78, URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002321/WC500112860.pdf, XP002698002
		- Anonymous, "Full Prescribing Information and Patient Information for ZEJULA(TM) ", Full Prescribing Information and Patient Information for ZEJULA(TM), U.S. Food and Drug Administration, (20170301), pages 1 - 19, Full Prescribing Information and Patient Information for ZEJULA(TM) , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf, (20240129), XP093124692
		- Anonymous, "COMMISSION IMPLEMENTING DECISION of 5.9.2011 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Zytiga -abiraterone", a medicinal product for human use", COMMISSION IMPLEMENTING DECISION, European Commission, (20110905), vol. C(2011)6379, pages 1 - 3, XP093124699
		- Anonymous, "COMMISSION IMPLEMENTING DECISION of 9.11.2016 amending the marketing authorisation granted by Decision C(2011)6379(final) for “Zytiga - abiraterone”, a medicinal product for human use", COMMISSION IMPLEMENTING DECISION, European Commission, (20161109), vol. C(2016) 7287, pages 1 - 3, XP093124705
		- Sandhu S. K., V. Moreno, G. Wilding, A. Omlin, W.R. Schelman Et Al., "112. PHASE I STUDY OF A POLY(ADP)-RIBOSE POLYMERASE (PARP) INHIBITOR MK-4827 (MK) WITH ANTITUMOUR ACTIVITY IN SPORADIC CASTRATION RESISTANT PROSTATE CANCER (CRPC)", Asia-Pacific Journal of Clinical Oncology, John Wiley & Sons, Inc., Hoboken, USA, Hoboken, USA, (20120701), vol. 8, no. suppl. 1, doi:10.1111/j.1743-7563.2012.01575.x, ISSN 1743-7555, page 33, XP093122422 DOI: http://dx.doi.org/10.1111/j.1743-7563.2012.01575.x
		- Michie Caroline Ogilvie, Sandhu Shahneen Kaur, Schelman William R., Molife L Rhoda, Wilding George, Omlin Aurelius Gabriel, Kansra Vikram, Brooks David G., Martell Robert E., Kaye Stanley B., De Bono Johann Sebastian, Wenham Robert Michael, "Final results of the phase I trial of niraparib (MK4827), a poly(ADP)ribose polymerase (PARP) inhibitor incorporating proof of concept biomarker studies and expansion cohorts involving BRCA1/2 mutation carriers, sporadic ovarian, and castration resistant prostate cancer (CRPC).", Journal of Clinical Oncology, American Society of Clinical Oncology, US, US , (20130520), vol. 31, no. 15_suppl, doi:10.1200/jco.2013.31.15_suppl.2513, ISSN 0732-183X, pages 2513 - 2513, XP093071671 DOI: http://dx.doi.org/10.1200/jco.2013.31.15_suppl.2513
		- Jingsong Zhang, "Poly (ADP-ribose) polymerase inhibitor: an evolving paradigm in the treatment of prostate cancer", Asian Journal of Andrology, Nature Publishing Group, US, US , (20140101), vol. 16, no. 3, doi:10.4103/1008-682X.123684, ISSN 1008-682X, page 401, XP055472262 DOI: http://dx.doi.org/10.4103/1008-682X.123684
		- Anonymous, "Janssen Enters Worldwide Collaboration and License Agreement with TESARO, Inc., for Niraparib in Prostate Cancer", News Releases, Johnson & Johnson, (20160406), pages 1 - 3, News Releases, URL: https://web.archive.org/web/20211115052216/https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/janssen-enters-worldwide-collaboration-and-license-agreement, (20240129), XP093124835
		- Anonymous, "TESARO ANNOUNCES GLOBAL PROSTATE CANCER COLLABORATION AND LICENSING AGREEMENT WITH JANSSEN", News Release, GLOBE NEWSWIRE, (20160406), pages 1 - 2, News Release, URL: https://www.sec.gov/Archives/edgar/data/1491576/000110465916110703/a16-8184_1ex99d1.htm, (20240129), XP093124837
		- Anonymous, "Monetizing Focus: Tesaro Adds Runway By Out-licensing Niraparib In Prostate Cancer", The Pink Sheet Daily, Pharma Intelligence UK Limited (Citeline), (20160406), pages 1 - 3, The Pink Sheet Daily, URL: https://pink.pharmaintelligence.informa.com/PS079383, (20240129), XP093124841
		- Anonymous, "NCT02924766: A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)", ClinicalTrials.gov, US NLM, (20180201), pages 1 - 11, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT02924766?tab=history&a=9, (20240129), XP093124848
		- Anonymous, "NCT01576172 \| Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer", ClinicalTrials.gov, US NLM, (20161222), pages 1 - 25, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT01576172?cond=NCT01576172&rank=1&tab=history&a=52, (20240129), XP093124851
		- Anonymous, "Clinical Trials: What You Need to Know", All About Cancer > Managing Cancer Care > Making Decisions and Managing Your Treatment > Clinical Trials, American Cancer Society, (20200818), pages 1 - 30, All About Cancer > Managing Cancer Care > Making Decisions and Managing Your Treatment > Clinical Trials , URL: https://www.cancer.org/content/dam/CRC/PDF/Public/6800.00.pdf, (20240129), XP093124853
		- J. P. Palma, Wang Y.-C., Rodriguez L. E., Montgomery D., Ellis P. A., Bukofzer G., Niquette A., Liu X., Shi Y., Lasko L., Zhu G.-D., Penning T. D., Giranda V. L., Rosenberg S. H., Frost D. J., Donawho C. K., "ABT-888 Confers Broad In vivo Activity in Combination with Temozolomide in Diverse Tumors", Clinical Cancer Research, Association for Cancer Research, (20091201), vol. 15, no. 23, doi:10.1158/1078-0432.CCR-09-1245, ISSN 10780432, pages 7277 - 7290, XP055078012 DOI: http://dx.doi.org/10.1158/1078-0432.CCR-09-1245
		- Antonarakis Emmanuel, Boudadi Karim, "Resistance to Novel Antiandrogen Therapies in Metastatic Castration-Resistant Prostate Cancer", Clinical Medicine Insights: Oncology, Libertas Academica Ltd., NZL, NZL , (20160211), vol. 10, no. S1, doi:10.4137/CMO.S34534, ISSN 1179-5549, pages 1 - 9, XP093124856 DOI: http://dx.doi.org/10.4137/CMO.S34534
		- Taylor Amy K., Kosoff David, Emamekhoo Hamid, Lang Joshua M., Kyriakopoulos Christos E., "PARP inhibitors in metastatic prostate cancer", Frontiers in Oncology, Frontiers Research Foundation, CH, CH , (20230424), vol. 13, doi:10.3389/fonc.2023.1159557, ISSN 2234-943X, pages 1 - 11, XP093127189 DOI: http://dx.doi.org/10.3389/fonc.2023.1159557
		- Shahneen K Sandhu, William R Schelman, George Wilding, Victor Moreno, Richard D Baird, Susana Miranda, Lucy Hylands, Ruth Riisnaes, Martin Forster, Aurelius Omlin, Nathan Kreischer, Khin Thway, Heidrun Gevensleben, Linda Sun, John Loughney, Manash Chatterjee, Carlo Toniatti, Christopher L Carpenter, Robert Iannone, Stan B Kaye, Johann S De Bono, Robert M Wenham, "The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial", The Lancet Oncology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20130801), vol. 14, no. 9, doi:10.1016/S1470-2045(13)70240-7, pages 882 - 892, XP055407449 DOI: http://dx.doi.org/10.1016/S1470-2045(13)70240-7
		- Anonymous, "History of Changes for Study: NCT02924766 A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)", ClinicalTrials.gov NCT02924766, (20170512), ClinicalTrials.gov NCT02924766, URL: https://clinicaltrials.gov/study/NCT02924766?tab=history, (20240205), XP093127193
		- Anonymous, "Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer ", ClinicalTrials.gov. History of Changes for Study: NCT01972217, (20170202), ClinicalTrials.gov. History of Changes for Study: NCT01972217, URL: https://classic.clinicaltrials.gov/ct2/show/NCT01972217, (20240205), XP093127206
		- Anonymous, "Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic CastrationResistant Prostate Cancer With DNA Repair Defects ", clinicaltrials.gov. History of Changes for Study: NCT03012321, (20170208), clinicaltrials.gov. History of Changes for Study: NCT03012321, URL: https://classic.clinicaltrials.gov/ct2/history/NCT03012321?V_14=View, (20240205), XP093127202
		- Anonymous, "amending the marketing authorisation granted by Decision C(2011)6379(final) for "Zytiga abiraterone", a medicinal product for human use", European Commission: Amended marketing authorisation for Zytiga; www.ec.europa.eu; 9 November 2016, (20161109), European Commission: Amended marketing authorisation for Zytiga; www.ec.europa.eu; 9 November 2016, (20240205), XP093127210
		- Matthew J. Schiewer, "Supplemental Figures: Dual Roles of PARP-1 Promote Cancer Growth and Progression", CANCER DISCOVERY, American Association for Cancer Research, US, US , (20121201), vol. 2, no. 12, doi:10.1158/2159-8290.CD-12-0120, ISSN 2159-8274, pages 1 - 9, XP093161314 DOI: http://dx.doi.org/10.1158/2159-8290.CD-12-0120
		- K.N. Chi, "Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial", Annals of Oncology, Elsevier, (20230901), vol. 34, no. 9, doi:10.1016/j.annonc.2023.06.009, ISSN 0923-7534, pages 772 - 782, XP093161315 DOI: http://dx.doi.org/10.1016/j.annonc.2023.06.009
		- Anonymous, "Akeega 50 mg/500 mg film-coated tablets // Akeega 100 mg/500 mg film-coated tablets", ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, European Medicines Agency, (20230602), pages 1 - 57, ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, URL: https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf, XP093161320
		- Anonymous, "AKEEGA (TM) (niraparib and abiraterone acetate) tablets, for oral use", HIGHLIGHTS OF PRESCRIBING INFORMATION, FDA - U.S. Food and Drug Administration, (20230801), pages 1 - 32, HIGHLIGHTS OF PRESCRIBING INFORMATION, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216793s000lbl.pdf, XP093161323
		- Hussain Maha; Daignault-Newton Stephanie; Twardowski Przemyslaw W; Albany Costantine; Stein Mark N; Kunju Lakshmi P; Siddiqui Javed; Wu Yi-Mi; Robinson Dan; Lonigro Robert J; Cao Xuhong; Tomlins Scott A; Mehra Rohit; Cooney Kathleen A; Montgomery Bruce; Antonarakis Emmanuel S; Shevrin Daniel H; Corn Paul G; Whang Young E; Smith David C; Caram Megan V; Knudsen Karen E; Stadler Walter M; Feng Felix Y; Chinnaiyan Arul M, "Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012.", Journal of Clinical Oncology, Grune & Stratton, (20180401), vol. 36, no. 10, doi:10.1200/JCO.2017.75.7310, ISSN 0732-183X, pages 991 - 999, XP009506016 DOI: http://dx.doi.org/10.1200/JCO.2017.75.7310
		- Anonymous, "Cellosaurus VCaP (CVCL_2235)", Expasy, (20120404), Database accession no. CVCL_2235, XP093161332
		- Robert H. Carlson, "PARP Inhibitors Show Promise Against Metastatic Triple-Negative Breast Cancer in Early Studies", Oncology Times, Lippincott Williams & Wilkins, Inc., (20090801), vol. 31, no. Suppl. 1, doi:10.1097/01.COT.0000359114.36813.cb, ISSN 0276-2234, pages 10 - 11, XP093161336 DOI: http://dx.doi.org/10.1097/01.COT.0000359114.36813.cb
		- E. Lesaffre, "Statistical controversies in clinical research: futility analyses in oncology-lessons on potential pitfalls from a randomized controlled trial", Annals of Oncology, Elsevier, (20170701), vol. 28, no. 7, doi:10.1093/annonc/mdx042, ISSN 0923-7534, pages 1419 - 1426, XP093161340 DOI: http://dx.doi.org/10.1093/annonc/mdx042
		- Yvette Drew, Timothy A. Yap, Stan B. Kaye, "Chapter 7: The future of PARP inhibitors in the treatment of cancer", Yvette Drew, Timothy A. Yap, Stan B. Kaye, Kehoe, Sean, Gynaecological Cancers: Biology and Therapeutics, RCOG Press, (20110601), pages 83 - 98, ISBN 978-1-906985-44-8, XP009554023
		- Anand G. Patel, "Failure of Iniparib to Inhibit Poly(ADP-Ribose) Polymerase In Vitro", Clinical Cancer Research, Association for Cancer Research, US, US, (20120315), vol. 18, no. 6, doi:10.1158/1078-0432.CCR-11-2890, ISSN 1078-0432, pages 1655 - 1662, XP093161348 DOI: http://dx.doi.org/10.1158/1078-0432.CCR-11-2890
		- J. Murai, S.-Y. N. Huang, B. B. Das, A. Renaud, Y. Zhang, J. H. Doroshow, J. Ji, S. Takeda, Y. Pommier, "Trapping of PARP1 and PARP2 by Clinical PARP Inhibitors", Cancer research, American Association for Cancer Research, US, US, (20121101), vol. 72, no. 21, doi:10.1158/0008-5472.CAN-12-2753, ISSN 0008-5472, pages 5588 - 5599, XP055407452 DOI: http://dx.doi.org/10.1158/0008-5472.CAN-12-2753
		- Albert A. Antolín, "Linking off-target kinase pharmacology to the differential cellular effects observed among PARP inhibitors", Oncotarget, Impact Journals LLC, United States, United States , (20140530), vol. 5, no. 10, doi:10.18632/oncotarget.1814, ISSN 1949-2553, pages 3023 - 3028, XP093161354 DOI: http://dx.doi.org/10.18632/oncotarget.1814
		- Albert A. Antolin, "The kinase polypharmacology landscape of clinical PARP inhibitors", Scientific Reports, Nature Publishing Group, US, US , (20200217), vol. 10, no. 1, doi:10.1038/s41598-020-59074-4, ISSN 2045-2322, pages 2585 - 14, XP093161360 DOI: http://dx.doi.org/10.1038/s41598-020-59074-4
		- Todd A. Hopkins, "Mechanistic Dissection of PARP1 Trapping and the Impact on In Vivo Tolerability and Efficacy of PARP Inhibitors", MOLECULAR CANCER RESEARCH, American Association for Cancer Research, US, US , (20151101), vol. 13, no. 11, doi:10.1158/1541-7786.MCR-15-0191-T, ISSN 1541-7786, pages 1465 - 1477, XP093161370 DOI: http://dx.doi.org/10.1158/1541-7786.MCR-15-0191-T
		- Elisabet Wahlberg, Tobias Karlberg, Ekaterina Kouznetsova, Natalia Markova, Antonio Macchiarulo, Ann-Gerd Thorsell, Ewa Pol, Åsa Frostell, Torun Ekblad, Delal Öncü, Björn Kull, Graeme Michael Robertson, Roberto Pellicciari, Herwig Schüler, Johan Weigelt, "Family-wide chemical profiling and structural analysis of PARP and tankyrase inhibitors", Nature Biotechnology, Nature Publishing Group US, New York, New York, vol. 30, no. 3, doi:10.1038/nbt.2121, ISSN 1087-0156, pages 283 - 288, XP055417170 DOI: http://dx.doi.org/10.1038/nbt.2121
		- Ann-Gerd Thorsell, Torun Ekblad, Tobias Karlberg, Mirjam Löw, Ana Filipa Pinto, Lionel Trésaugues, Martin Moche, Michael S. Cohen, Herwig Schüler, "Structural Basis for Potency and Promiscuity in Poly(ADP-ribose) Polymerase (PARP) and Tankyrase Inhibitors", Journal of Medicinal Chemistry, American Chemical Society, US, US , (20170223), vol. 60, no. 4, doi:10.1021/acs.jmedchem.6b00990, ISSN 0022-2623, pages 1262 - 1271, XP055730220 DOI: http://dx.doi.org/10.1021/acs.jmedchem.6b00990
		- Knezevic Claire E.; Wright Gabriela; Remsing Rix Lily L.; Kim Woosuk; Kuenzi Brent M.; Luo Yunting; Watters January M.; Koomen John M.; Haura Eric B.; Monteiro Alvaro N.; Radu Caius; Lawrence Harshani R.; Rix Uwe, "Proteome-wide Profiling of Clinical PARP Inhibitors Reveals Compound-Specific Secondary Targets", Cell Chemical Biology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20161117), vol. 23, no. 12, doi:10.1016/j.chembiol.2016.10.011, ISSN 2451-9456, pages 1490 - 1503, XP029861338 DOI: http://dx.doi.org/10.1016/j.chembiol.2016.10.011
		- Al Wasilewski, "Johnson & Johnson Completes Acquisition Of Aragon Pharmaceuticals, Inc.", Johnson & Johnson / Press releases / Pharmaceuticals, Johnson & Johnson Services, Inc., (20130819), pages 1 - 5, Johnson & Johnson / Press releases / Pharmaceuticals, URL: https://www.jnj.com/media-center/press-releases/johnson-johnson-completes-acquisition-of-aragon-pharmaceuticals-inc, XP093161434
		- Alessandro Tenuta; Laurence Klotz; Jayson L. Parker, "Clinical trial risk in castration‐resistant prostate cancer: immunotherapies show promise", BJU International, Blackwell Science, Hoboken, USA, Hoboken, USA, (20131202), vol. 113, doi:10.1111/bju.12309, ISSN 1464-4096, pages E82 - E89, XP072219152 DOI: http://dx.doi.org/10.1111/bju.12309
		- Saad Fred; Chi Kim N.; Shore Neal D.; Graff Julie N.; Posadas Edwin M.; Lattouf Jean-Baptiste; Espina Byron M.; Zhu Eugene; Yu Alex; Hazra Anasuya; De Meulder Marc; Mamidi Rao N. V. S.; Bradic Branislav; Francis Peter; Hayreh Vinny; Rezazadeh Kalebasty Arash, "Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE)", Cancer chemotherapy and pharmacology, Springer Verlag , Berlin, DE, DE , (20210322), vol. 88, no. 1, doi:10.1007/s00280-021-04249-7, ISSN 0344-5704, pages 25 - 37, XP037463617 DOI: http://dx.doi.org/10.1007/s00280-021-04249-7

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