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Year Number of Results
2004 1
2011 2
2012 1
2015 2
2017 2
2018 2
2019 3
2020 8
2021 6
2022 11
2023 7
2024 2

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44 results

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Page 1
Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.
Donaldson JM, Seddiq M, Fusco MJ, Singla S, Pamuk GE, Lee-Alonso RJ, Mixter BD, Goldberg KB, Amiri-Kordestani L, de Claro RA, Drezner N, Gormley NJ, Kanapuru B, Lemery SJ, Fashoyin-Aje LA, Richardson NC, Singh H, Suzman DL, Theoret MR, Kluetz PG, Pazdur R. Donaldson JM, et al. Among authors: de claro ra. Cancer Discov. 2023 Dec 12;13(12):2515-2524. doi: 10.1158/2159-8290.CD-23-1226. Cancer Discov. 2023. PMID: 38084090
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
Amatya AK, Fiero MH, Bloomquist EW, Sinha AK, Lemery SJ, Singh H, Ibrahim A, Donoghue M, Fashoyin-Aje LA, de Claro RA, Gormley NJ, Amiri-Kordestani L, Sridhara R, Theoret MR, Kluetz PG, Pazdur R, Beaver JA, Tang S. Amatya AK, et al. Among authors: de claro ra. Clin Cancer Res. 2021 Nov 1;27(21):5753-5756. doi: 10.1158/1078-0432.CCR-20-4912. Epub 2021 Jun 11. Clin Cancer Res. 2021. PMID: 34117032 Free PMC article. Review.
Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.
Hotaki LT, Shrestha A, Bennett MP, Valdes IL, Lee SH, Wang Y, Spillman D, MacAulay T, Hunt M, Gervais J, Mafi M, Panetta V, Looi YH, Shum M, Atiek E, Meincke R, Rohr UP, Ainbinder D, Boehm-Cagan A, Luxenburg O, Cerqueira MR, Mouawad LS, Thees MFRES, Prasad K, de Claro RA. Hotaki LT, et al. Among authors: de claro ra. Ther Innov Regul Sci. 2023 Jul;57(4):875-885. doi: 10.1007/s43441-023-00522-4. Epub 2023 Apr 18. Ther Innov Regul Sci. 2023. PMID: 37072651 Review.
Project Orbis: Global Collaborative Review Program.
de Claro RA, Spillman D, Hotaki LT, Shum M, Mouawad LS, Santos GML, Robinson K, Hunt M, Healy C, Chan A, Looi YH, Rodrigues C, Rohr UP, Walther C, Pazdur R. de Claro RA, et al. Clin Cancer Res. 2020 Dec 15;26(24):6412-6416. doi: 10.1158/1078-0432.CCR-20-3292. Epub 2020 Oct 9. Clin Cancer Res. 2020. PMID: 33037016
Considerations for Drug Development in Myelodysplastic Syndromes.
Sekeres MA, Kim N, DeZern AE, Norsworthy KJ, Garcia JS, de Claro RA, Theoret MR, Jen EY, Ehrlich LA, Zeidan AM, Komrokji RS. Sekeres MA, et al. Among authors: de claro ra. Clin Cancer Res. 2023 Jul 14;29(14):2573-2579. doi: 10.1158/1078-0432.CCR-22-3348. Clin Cancer Res. 2023. PMID: 36688922 Free PMC article.
Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.
Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM. Thanarajasingam G, et al. Among authors: de claro ra. Lancet Haematol. 2018 Nov;5(11):e563-e598. doi: 10.1016/S2352-3026(18)30051-6. Epub 2018 Jun 18. Lancet Haematol. 2018. PMID: 29907552 Free PMC article. Review.
Project Confirm: Accelerated Drug Approvals for CML-Response.
Sweet KL, Cortes JE, Apperley JF, Mann M, Mauro MJ, Oehler VG, Ruiz C, Schiffer CA, Ehrlich LA, Pamuk GE, Wynne J, Mehta GU, Okusanya OO, de Claro RA, Theoret MR, Smith BD, Norsworthy KJ. Sweet KL, et al. Among authors: de claro ra. Clin Cancer Res. 2024 Jan 5;30(1):237-238. doi: 10.1158/1078-0432.CCR-23-3234. Clin Cancer Res. 2024. PMID: 38178776 No abstract available.
Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.
Thanarajasingam G, Minasian LM, Bhatnagar V, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gormley N, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Kwong YL, Little RF, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Nair A, Nastoupil L, Robertson K, Sidana S, Smedby KE, Sonneveld P, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Seymour JF, Habermann TM. Thanarajasingam G, et al. Among authors: de claro ra. Lancet Haematol. 2022 May;9(5):e374-e384. doi: 10.1016/S2352-3026(22)00045-X. Lancet Haematol. 2022. PMID: 35483398 Free PMC article. Review.
44 results