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Page 1
Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis.
Norsworthy KJ, Mulkey F, Scott EC, Ward AF, Przepiorka D, Charlab R, Dorff SE, Deisseroth A, Kazandjian D, Sridhara R, Beaver JA, Farrell AT, de Claro RA, Pazdur R. Norsworthy KJ, et al. Among authors: dorff se. Clin Cancer Res. 2020 Aug 15;26(16):4280-4288. doi: 10.1158/1078-0432.CCR-20-0834. Epub 2020 May 11. Clin Cancer Res. 2020. PMID: 32393603 Free PMC article.
FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.
Lee HZ, Kwitkowski VE, Del Valle PL, Ricci MS, Saber H, Habtemariam BA, Bullock J, Bloomquist E, Li Shen Y, Chen XH, Brown J, Mehrotra N, Dorff S, Charlab R, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. Lee HZ, et al. Clin Cancer Res. 2015 Jun 15;21(12):2666-70. doi: 10.1158/1078-0432.CCR-14-3119. Epub 2015 Mar 23. Clin Cancer Res. 2015. PMID: 25802282
FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs.
Ison G, Beaver JA, McGuinn WD Jr, Palmby TR, Dinin J, Charlab R, Marathe A, Jin R, Liu Q, Chen XH, Ysern X, Stephens O, Bai G, Wang Y, Dorff SE, Cheng J, Tang S, Sridhara R, Pierce W, McKee AE, Ibrahim A, Kim G, Pazdur R. Ison G, et al. Among authors: dorff se. Clin Cancer Res. 2016 Sep 15;22(18):4545-9. doi: 10.1158/1078-0432.CCR-16-0638. Epub 2016 Jul 11. Clin Cancer Res. 2016. PMID: 27401247 Review.
Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.
Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M. Schuck RN, et al. Among authors: dorff se. Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23. Clin Pharmacol Ther. 2018. PMID: 29473145 Free PMC article. Review.
FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation.
Norsworthy KJ, Luo L, Hsu V, Gudi R, Dorff SE, Przepiorka D, Deisseroth A, Shen YL, Sheth CM, Charlab R, Williams GM, Goldberg KB, Farrell AT, Pazdur R. Norsworthy KJ, et al. Among authors: dorff se. Clin Cancer Res. 2019 Jun 1;25(11):3205-3209. doi: 10.1158/1078-0432.CCR-18-3749. Epub 2019 Jan 28. Clin Cancer Res. 2019. PMID: 30692099
FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma.
Chang E, Weinstock C, Zhang L, Charlab R, Dorff SE, Gong Y, Hsu V, Li F, Ricks TK, Song P, Tang S, Waldron PE, Yu J, Zahalka E, Goldberg KB, Pazdur R, Theoret MR, Ibrahim A, Beaver JA. Chang E, et al. Among authors: dorff se. Clin Cancer Res. 2021 Feb 15;27(4):922-927. doi: 10.1158/1078-0432.CCR-20-2275. Epub 2020 Sep 22. Clin Cancer Res. 2021. PMID: 32962979
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer.
Wahby S, Fashoyin-Aje L, Osgood CL, Cheng J, Fiero MH, Zhang L, Tang S, Hamed SS, Song P, Charlab R, Dorff SE, Ricks TK, Barnett-Ringgold K, Dinin J, Goldberg KB, Theoret MR, Pazdur R, Amiri-Kordestani L, Beaver JA. Wahby S, et al. Among authors: dorff se. Clin Cancer Res. 2021 Apr 1;27(7):1850-1854. doi: 10.1158/1078-0432.CCR-20-3119. Epub 2020 Nov 9. Clin Cancer Res. 2021. PMID: 33168656 Clinical Trial.
FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.
Fallah J, Brave MH, Weinstock C, Mehta GU, Bradford D, Gittleman H, Bloomquist EW, Charlab R, Hamed SS, Miller CP, Dorff SE, Chambers WA, Mixter BD, Dinin J, Pierce WF, Ricks TK, Tang S, Donoghue M, Pazdur R, Amiri-Kordestani L, Ibrahim A, Beaver JA. Fallah J, et al. Among authors: dorff se. Clin Cancer Res. 2022 Nov 14;28(22):4843-4848. doi: 10.1158/1078-0432.CCR-22-1054. Clin Cancer Res. 2022. PMID: 35727604 Free PMC article.
[No title available]
[No authors listed] [No authors listed] PMID: 37219515
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Duke ES, Bradford D, Marcovitz M, Amatya AK, Mishra-Kalyani PS, Nguyen E, Price LSL, Fourie Zirkelbach J, Li Y, Bi Y, Kraft J, Dorff SE, Scepura B, Stephenson M, Ojofeitimi I, Nair A, Han Y, Tezak Z, Lemery SJ, Pazdur R, Larkins E, Singh H. Duke ES, et al. Among authors: dorff se. Clin Cancer Res. 2023 Sep 15;29(18):3573-3578. doi: 10.1158/1078-0432.CCR-23-0459. Clin Cancer Res. 2023. PMID: 37265412 Free PMC article. Clinical Trial.
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