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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: de claro ra. 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.
U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphoma.
de Claro RA, McGinn K, Kwitkowski V, Bullock J, Khandelwal A, Habtemariam B, Ouyang Y, Saber H, Lee K, Koti K, Rothmann M, Shapiro M, Borrego F, Clouse K, Chen XH, Brown J, Akinsanya L, Kane R, Kaminskas E, Farrell A, Pazdur R. de Claro RA, et al. Clin Cancer Res. 2012 Nov 1;18(21):5845-9. doi: 10.1158/1078-0432.CCR-12-1803. Epub 2012 Sep 7. Clin Cancer Res. 2012. PMID: 22962441
FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma.
Miller BW, Przepiorka D, de Claro RA, Lee K, Nie L, Simpson N, Gudi R, Saber H, Shord S, Bullock J, Marathe D, Mehrotra N, Hsieh LS, Ghosh D, Brown J, Kane RC, Justice R, Kaminskas E, Farrell AT, Pazdur R. Miller BW, et al. Among authors: de claro ra. Clin Cancer Res. 2015 Apr 1;21(7):1525-9. doi: 10.1158/1078-0432.CCR-14-2522. Epub 2015 Feb 2. Clin Cancer Res. 2015. PMID: 25645861
FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.
de Claro RA, McGinn KM, Verdun N, Lee SL, Chiu HJ, Saber H, Brower ME, Chang CJ, Pfuma E, Habtemariam B, Bullock J, Wang Y, Nie L, Chen XH, Lu DR, Al-Hakim A, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. de Claro RA, et al. Clin Cancer Res. 2015 Aug 15;21(16):3586-90. doi: 10.1158/1078-0432.CCR-14-2225. Clin Cancer Res. 2015. PMID: 26275952
Dose Finding in Late-Phase Drug Development.
Nie L, Lee KY, Verdun N, De Claro RA, Sridhara R. Nie L, et al. Among authors: de claro ra. Ther Innov Regul Sci. 2017 Nov;51(6):738-743. doi: 10.1177/2168479017709297. Epub 2017 May 30. Ther Innov Regul Sci. 2017. PMID: 30227101
46 results