| DESCRIPTION | - ANTONESCU et al., Am J Surg Pathol, (20150000), vol. 39, no. 7, pages 957 - 67 | - |
| DESCRIPTION | - BASELGA J et al., J Clin Oncol, (20050000), vol. 23, no. 23, pages 5323 - 33 | - |
| DESCRIPTION | - CECCHIRINI et al., Oncogene, (19970000), vol. 14, pages 2609 - 12 | - |
| DESCRIPTION | - DRUKER BJ, N Engl J Med, (20010000), vol. 344, no. 14, pages 1031 - 7 | - |
| DESCRIPTION | - ELISEI R. et al., J Clin Endocrinol Metab., (20080000), vol. 93, pages 682 - 687 | - |
| DESCRIPTION | - European Journal of Cancer, (20090000), vol. 45, pages 228 - 247 | - |
| DESCRIPTION | - FAGIN JA; WELLS SA JR., N Engl J Med., (20160915), vol. 375, no. 11, pages 1054 - 67 | - |
| DESCRIPTION | - FANG et al., Journal of Thoracic Oncology, (20160000), vol. 11.2, pages S21 - S22 | - |
| DESCRIPTION | - GAUTSHI O et al., J Clin Oncol., (20160000), vol. 34 | - |
| DESCRIPTION | - GRUBBS et al., J Clin Endocrinol Metab, (20150000), vol. 100, pages 788 - 93 | - |
| DESCRIPTION | - HALKOVA et al., Human Pathology, (20150000), vol. 46, pages 1962 - 69 | - |
| DESCRIPTION | - HORIIKE A et al., Lung Cancer, (20160300), vol. 93, pages 43 - 6 | - |
| DESCRIPTION | - JOUNG et al., Histopathology, (20160000), vol. 69, no. l, pages 45 - 53 | - |
| DESCRIPTION | - JOVANOVIC et al., Prilozi, (20150000), vol. 36, no. 1, pages 93 - 107 | - |
| DESCRIPTION | - KARRASCH et al., Eur. Thyroid J, (20160000), vol. 5, no. 1, pages 73 - 77 | - |
| DESCRIPTION | - KATO et al., Clin. Cancer Res., (20170000), vol. 23, no. 8, pages 1988 - 97 | - |
| DESCRIPTION | - KIM et al., ACTA ENDOCRINOLOGICA-BUCHAREST, (20150000), vol. 11.2, pages 189 - 194 | - |
| DESCRIPTION | - KRAMPITZ et al., Cancer, (20140000), vol. 120, pages 1920 - 31 | - |
| DESCRIPTION | - LATTEYER et al., J Clin. Endocrinol. Metab., (20160000), vol. 101, no. 3, pages 1016 - 22 | - |
| DESCRIPTION | - LE ROLLE et al., Oncotcirget, (20150000), vol. 6, no. 30, pages 28929 - 37 | - |
| DESCRIPTION | - LIN JJ et al., J Thorac Oncol., (20161100), vol. 11, no. 11, pages 2027 - 32 | - |
| DESCRIPTION | - LIPSON, D. et al., Nat. Med., (20120000), vol. 18, pages 382 - 384 | - |
| DESCRIPTION | - MACHENS A et al., N Engl J Med, (20030000), vol. 349, pages 1517 - 25 | - |
| DESCRIPTION | - MOURA MM et al., British Journal of Cancer, (20090000), vol. 1, no. 00, pages 1777 - 1783 | - |
| DESCRIPTION | - MULLIGAN LM et al., J Int Med., (19950000), vol. 238, no. 4, pages 343 - 346 | - |
| DESCRIPTION | - MULLIGAN LM et al., Nature, (19930603), vol. 363, no. 6428, pages 458 - 60 | - |
| DESCRIPTION | - MULLIGAN LM., Nat. Rev. Cancer., (20140000), vol. 14, pages 173 - 186 | - |
| DESCRIPTION | - Nature Reviews Cancer, (20140000), vol. 14, pages 173 - 86 | - |
| DESCRIPTION | - PIRKER et al., Trans! Lung Cancer Res, (20150000), vol. 4, no. 6, pages 797 - 800 | - |
| DESCRIPTION | - QI et al., Oncotarget, (20150000), vol. 6, no. 32, pages 33993 - 4003 | - |
| DESCRIPTION | - ROMEI C et al., Nat Rev Endocrinol., (20160400), vol. 12, no. 4, pages 192 - 202 | - |
| DESCRIPTION | - SAITO et al., Cancer Science, (20160000), vol. 107, pages 713 - 20 | - |
| DESCRIPTION | - SARKER D; WORKMAN P, Aclv Cancer Res, (20070000), vol. 96, pages 213 - 68 | - |
| DESCRIPTION | - SARKER D; WORKMAN P, Adv Cancer Res, (20070000), vol. 96, pages 213 - 68 | - |
| DESCRIPTION | - SCOLLO et al., Endocr. J, (20160000), vol. 63, pages 87 - 91 | - |
| DESCRIPTION | - SILVA et al., Endocrine, (20150000), vol. 49, no. 2, pages 366 - 72 | - |
| DESCRIPTION | - STRANSKY, N. et al., Nat. Commun., (20140000), vol. 5, page 4846 | - |
| DESCRIPTION | - SUEHARA Y et al., Clin Cancer Res., (20120000), vol. 18, no. 24, pages 6599 - 608 | - |
| DESCRIPTION | - TAKEUCHI, K. et al., Nat. Med., (20120000), vol. 18, pages 378 - 381 | - |
| DESCRIPTION | - TAN DS, Cancer J, (20090000), vol. 15, no. 5, pages 406 - 20 | - |
| DESCRIPTION | - WANG L et al., Genes Chromosomes Cancer, (20120000), vol. 51, no. 2, pages 127 - 39 | - |
| DESCRIPTION | - WELLS et al., Thyroid, (20150000), vol. 25, pages 567 - 610 | - |
| EXAMINATION | - Anonymous, "Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers", Guidance for Industry, (20050701), pages 1 - 30, URL: https://www.fda.gov/media/72309/download, (20221121), XP093000005 | - |
| EXAMINATION | - Kamil Noor, "Dose estimation, conversion and translation from animal to human and human to animal for clinical and animal studies", Int. J. Biol. Biotech., (20170701), pages 311 - 317, URL: https://www.researchgate.net/publication/322329638_Dose_estimation_conversion_and_translation_from_animal_to_human_and_human_to_animal_for_clinical_and_animal_studies, (20221121), XP093000013 | - |
| EXAMINATION | - Rami Rahal ET AL, "BLU-667 is a potent and highly selective RET inhibitor being developed for RET- driven cancers", Molecular Cancer Therapeutics, (20180101), page 1, URL: https://www.blueprintmedicines.com/wp-content/uploads/2018/12/BLU-667-EORTC-2017-BPM.pdf, (20191120), XP055644433 | - |
| EXAMINATION | - Subbiah V. ET AL, "Clinical activity and safety of the RET inhibitor pralsetinib in patients with RET fusion-positive solid tumours: update from the ARROW trial", ASCO, (20210604), pages 1 - 1, URL: https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.3079, (20221121), XP093000210 | - |
| EXAMINATION | - Shannon Reagan-Shaw ET AL, "Dose translation from animal to human studies revisited", The FASEB Journal, & EXPERIMENTAL BIOLOGY MEETING; SAN DIEGO, CA, USA; APRIL 21 -25, 2018, (20080301), vol. 22, no. 3, doi:10.1096/fj.07-9574LSF, ISSN 0892-6638, pages 659 - 661, XP055542714 | |
| EXAMINATION | - Pound Pandora J ET AL, "Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail", J. Transl Med, doi:10.1186/s12967-018-1678-1, (20180101), pages 1 - 8, URL: https://www.researchgate.net/publication/328793141_Is_it_possible_to_overcome_issues_of_external_validity_in_preclinical_animal_research_Why_most_animal_models_are_bound_to_fail, (20221121), XP093000231 | |
| INTERNATIONAL-SEARCH-REPORT | - ANONYMOUS, "Phase 1 Study of the Highly-selective RET Inhibitor BLU-667 in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors", INTERNET CITATION, (20170421), page 8pp, ClinicalTrials.org, URL: https://www.clinicaltrials.gov/ct2/history/NCT03037385?V_3=View#StudyPageTop, (20180807), XP002783685 [I] 1-7,12-17,24-29,35-53,56,57,59-64 * Study description; page 2 * * Arms; page 3 * * Secondary outcome measures 10, 11; pages 3-4 * * Key inclusion criteria; page 5 * [A] 8-11,18-23,30-34,54,55,58 | - |
| INTERNATIONAL-SEARCH-REPORT | - Subbiah et al., "Abstract CT043: Highly potent and selective RET inhibitor, BLU-667, achieves proof of concept in a phase I study of advanced, RET-altered solid tumors", Proceedings: AACR Annual Meeting 2018; April 14-18, 2018; Chicago, IL, vol. 78, no. 13, Supplement 1, doi:10.1158/1538-7445.AM2018-CT043, ISSN 1538-7445, (201807), CANCER RESEARCH, URL: http://cancerres.aacrjournals.org/content/78/13_Supplement/CT043, (20190626), XP002792435 [XP] 1,3,4,8,18,30,43-45,48,51,56-58,61-63 * the whole document * | |
| INTERNATIONAL-SEARCH-REPORT | - VIVEK SUBBIAH ET AL, "Precision Targeted Therapy with BLU-667 for RET -Driven Cancers", CANCER DISCOVERY, US, (20180415), vol. 8, no. 7, doi:10.1158/2159-8290.CD-18-0338, ISSN 2159-8274, pages 836 - 849, XP055599279 [XP] 1,2,4,8,9,12,13,16-18,21,23,27-32,34,42-46,48-53,59-63 * abstract * * page 838, column 1, paragraph l - column 2, paragraph 1 * * page 839, column 2, paragraph l - page 841, column 1, paragraph 1 * * page 842, column 2, paragraph 2 - page 845, column 1, paragraph 1 * * page 845, column 2, paragraph 2 * * page 846, column 1, paragraphs 1-2 * | |
| INTERNATIONAL-SEARCH-REPORT | - Anonymous, "BLU-667 Targets RET-Altered Cancers.", vol. 8, no. 6, doi:10.1158/2159-8290.CD-NB2018-050, ISSN 2159-8290, (201806), Database accession no. OF8, page 5pp, CANCER DISCOVERY, URL: http://cancerdiscovery.aacrjournals.org/content/8/6/OF8.long, (20190625), XP002792436 [XP] 54,55 * page 1, paragraph 2 * * page 2, paragraphs 2-3 * | |
| INTERNATIONAL-SEARCH-REPORT | - BRUCE G. ROBINSON ET AL, "Vandetanib (100 mg) in Patients with Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer", JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM, US, (20100601), vol. 95, no. 6, doi:10.1210/jc.2009-2461, ISSN 0021-972X, pages 2664 - 2671, XP055599340 [X] 56,57,59,61-64 * abstract * * page 2667, column 2, paragraph 1 * * page 2668; table 3 * * page 2669; figure 2 * | |
| OPPOSITION | - Anonymous, "Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers", U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER, (20050701), pages 1 - 30, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER, URL: https://www.fda.gov/media/72309/download, (20240815), XP093195537 | - |
| OPPOSITION | - Anonymous, "Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors", Clinical trials, (20170421), pages 1 - 14, Clinical trials, URL: https://www.clinicaltrials.gov/ct2/history/NCT03037385?V_3=View#StudyPageTop, (20240815), XP093195466 | - |
| OPPOSITION | - Noor Kamil , Saba Kamil, "Dose estimation, conversion and translation from animal to human and human to animal for clinical and animal studies", Int. J. Biol. Biotech., (20170701), vol. 14, no. 3, pages 311 - 317, XP093000013 | - |
| OPPOSITION | - Subbiah Vivek, Cassier Philippe A., Siena Salvatore, Alonso Guzman, Paz-Ares Luis G., Garrido Pilar, Nadal Ernest, Curigliano Giuseppe, Vuky Jacqueline, Lopes Gilberto, Kalemkerian Gregory Peter, Bowles Daniel W., Seetharam Mahesh, Chang Jianhua, Zhang Hui, Ye Chaoyang, Green Jennifer, Zalutskaya Alena, Schuler Martin H., Fan Yun, "Clinical activity and safety of the RET inhibitor pralsetinib in patients with RET fusion-positive solid tumors: Update from the ARROW trial.", ASCO, (20210101), pages 1 - 1, XP093195495 | - |
| OPPOSITION | - Gainor Justin F; Curigliano Giuseppe; Kim Dong-Wan; Lee Dae Ho; Besse Benjamin; Baik Christina S; Doebele Robert C; Cassier Philippe A; Lopes Gilberto; Tan Daniel S W; Garralda Elena; Paz-Ares Luis G; Cho Byoung Chul; Gadgeel Shirish M; Thomas Michael; Liu Stephen V; Taylor Matthew H; Mansfield Aaron S; Zhu Viola W; Clifford Corinne; Zhang Hui; Palmer Michael; Green Jennifer; Turner Christopher D; Subbiah Vivek, "Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study", The Lancet Oncology, AMSTERDAM, NL , (20210609), vol. 22, no. 7, doi:10.1016/S1470-2045(21)00247-3, pages 959 - 969, XP086683177 | |
| OPPOSITION | - Alexander Drilon, Zishuo I. Hu, Gillianne G. Y. Lai, Daniel S. W. Tan, "Targeting RET-driven cancers: lessons from evolving preclinical and clinical landscapes", Nature reviews clinical oncology, NY, US , (20180301), vol. 15, no. 3, doi:10.1038/nrclinonc.2017.175, ISSN 1759-4774, pages 151 - 167, XP055719825 | |
| OPPOSITION | - Donna M, Graham, Aaron R. Hansen, Elizabeth A. Eisenhauer, Lillian L. Siu, "Basics of Phase I Design: First-in-Human Studies", Donna M, Graham, Aaron R. Hansen, Elizabeth A. Eisenhauer, Lillian L. Siu, Elizabeth A. Eisenhauer , Christopher Twelves , Marc Buyse, Phase I Cancer Clinical Trials: A Practical Guide (2 edn), Oxford University Press, (20150301), pages 58 - 91, ISBN 978-0-19-935901-1, XP093195538 | |
| OPPOSITION | - Shannon Reagan-Shaw, Minakshi Nihal, Nihal Ahmad, "Dose translation from animal to human studies revisited", The FASEB Journal, US, (20080301), vol. 22, no. 3, doi:10.1096/fj.07-9574LSF, ISSN 0892-6638, pages 659 - 661, XP055542714 | |
| OPPOSITION | - SUBBIAH V, "Highly potent and selective RET inhibitor, BLU-667, achieves proof of concept in a phase I study of advanced, RET-altered solid tumors", Cancer Research, US , (20180701), vol. 78, no. 13, Supplement 1, doi:10.1158/1538-7445.AM2018-CT043, ISSN 1538-7445, pages 1 - 4, XP002792435 | |
| OPPOSITION | - Subbiah Vivek; Taylor Matthew; Lin Jessica; Hu Mimi; Ou Sai-Hong Ignatius; Brose Marcia S; Garralda Elena; Clifford Corinne; Palmer Michael; Evans Erica; Shi Hongliang; Wolf Beni; Gainor Justin F, "CT043: Highly potent and selective RET inhibitor, BLU-667, achieves proof of concept in a phase I study of advanced, RET-altered solid tumors", Cancer Research, American Association for Cancer Research, US, US , (20180701), vol. 78, no. 13, Supplement 1, doi:10.1158/1538-7445.AM2018-CT043, ISSN 1538-7445, page CT043, XP002792435 | |
| OPPOSITION | - Vivek Subbiah, Justin F. Gainor, Rami Rahal, Jason D. Brubaker, Joseph L. Kim, Michelle Maynard, Wei Hu, Qiongfang Cao, Michael P. Sheets, Douglas Wilson, Kevin J. Wilson, Lucian Dipietro, Paul Fleming, Michael Palmer, Mimi I. Hu, Lori Wirth, Marcia S. Brose, Sai-Hong Ignatius Ou, Matthew Taylor, Elena Garralda, Stephen Miller, Beni Wolf, Christoph Lengauer, Timothy Guzi, Erica K. Evans, "Precision Targeted Therapy with BLU-667 for RET -Driven Cancers", Cancer discovery, US , (20180701), vol. 8, no. 7, doi:10.1158/2159-8290.CD-18-0338, ISSN 2159-8274, pages 836 - 849, XP055599279 | |
| OPPOSITION | - Anonymous, "BLU-667 Targets RET-Altered Cancers.", Cancer discovery, vol. 8, no. 6, doi:10.1158/2159-8290.CD-NB2018-050, ISSN 2159-8290, (20180601), page 5pp, Cancer discovery, URL: http://cancerdiscovery.aacrjournals.org/content/8/6/OF8.long, XP002792436 | |
| OPPOSITION | - Pound Pandora J, Ritskes‑hoitinga Merel, "Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail", Journal of Translational Medicine, (20180101), vol. 16, doi:10.1186/s12967‑018‑1678‑1, pages 1 - 8, XP093000231 | |
| OPPOSITION | - Bruce G. Robinson, Luis Paz-Ares, Annetta Krebs, James Vasselli, Robert Haddad, "Vandetanib (100 mg) in Patients with Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer", Journal of Clinical Endocrinology and Metabolism, US , (20100601), vol. 95, no. 6, doi:10.1210/jc.2009-2461, ISSN 0021-972X, pages 2664 - 2671, XP055599340 | |
