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Page 1
FDA Analysis of Ineligibility for Acute Myeloid Leukemia Clinical Trials by Race and Ethnicity.
Pulte D, Fernandes L, Wei G, Woods A, Norsworthy KJ, Gormley N, Kanapuru B, Gwise TE, Pazdur R, Schneider J, Theoret MR, Fashoyin-Aje LA, de Claro RA. Pulte D, et al. Among authors: gwise te. Clin Lymphoma Myeloma Leuk. 2023 Jun;23(6):463-470.e1. doi: 10.1016/j.clml.2023.03.012. Epub 2023 Mar 30. Clin Lymphoma Myeloma Leuk. 2023. PMID: 37076368
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.
Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. Kim G, et al. Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. Clin Cancer Res. 2015. PMID: 26187614 Review.
FDA's Approval of the First Biosimilar to Bevacizumab.
Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY, Yuan W, Rodriguez L, Gwise T, Rowzee A, Lim S, Keegan P, McKee AE, Pazdur R. Casak SJ, et al. Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9. Clin Cancer Res. 2018. PMID: 29743182
Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses.
Norsworthy KJ, Gao X, Ko CW, Pulte ED, Zhou J, Gong Y, Shen YL, Vallejo J, Gwise TE, Sridhara R, Deisseroth AB, Farrell AT, de Claro RA, Blumenthal GM, Pazdur R. Norsworthy KJ, et al. Among authors: gwise te. J Clin Oncol. 2022 Mar 10;40(8):847-854. doi: 10.1200/JCO.21.01548. Epub 2021 Dec 10. J Clin Oncol. 2022. PMID: 34890212 Free PMC article.
14 results