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FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
Bhatnagar V, Gormley NJ, Luo L, Shen YL, Sridhara R, Subramaniam S, Shen G, Ma L, Shord S, Goldberg KB, Farrell AT, McKee AE, Pazdur R. Bhatnagar V, et al. Among authors: gormley nj. Oncologist. 2017 Nov;22(11):1347-1353. doi: 10.1634/theoncologist.2017-0229. Epub 2017 Sep 13. Oncologist. 2017. PMID: 28904172 Free PMC article. Clinical Trial.
The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology.
Schneider JA, Gong Y, Goldberg KB, Kluetz PG, Theoret MR, Amiri-Kordestani L, Beaver JA, Fashoyin-Aje L, Gormley NJ, Jaigirdar AA, Lemery SJ, Mishra-Kalyani PS, Reaman GH, Rivera DR, Rubinstein WS, Singh H, Sridhara R, Pazdur R. Schneider JA, et al. Among authors: gormley nj. Clin Cancer Res. 2021 Oct 1;27(19):5161-5167. doi: 10.1158/1078-0432.CCR-20-4429. Clin Cancer Res. 2021. PMID: 33910935 Free PMC article.
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: gormley nj. 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.
Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health.
Chang E, Pelosof L, Lemery S, Gong Y, Goldberg KB, Farrell AT, Keegan P, Veeraraghavan J, Wei G, Blumenthal GM, Amiri-Kordestani L, Singh H, Fashoyin-Aje L, Gormley N, Kluetz PG, Pazdur R, Beaver JA, Theoret MR. Chang E, et al. Oncologist. 2021 Oct;26(10):e1786-e1799. doi: 10.1002/onco.13887. Epub 2021 Jul 27. Oncologist. 2021. PMID: 34196068 Free PMC article. Review.
Perspectives on Drug Development in Multiple Myeloma-Looking Forward to 2025.
Voorhees PM, Jakubowiak AJ, Kumar SK, Kanapuru B, Baines AC, Bhatnagar V, Ershler R, Theoret MR, Gormley NJ, Pazdur R. Voorhees PM, et al. Among authors: gormley nj. Clin Cancer Res. 2022 Jan 1;28(1):23-26. doi: 10.1158/1078-0432.CCR-21-1069. Epub 2021 Jul 27. Clin Cancer Res. 2022. PMID: 34315721
49 results