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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: przepiorka d. 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 Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation.
Pulte ED, Norsworthy KJ, Wang Y, Xu Q, Qosa H, Gudi R, Przepiorka D, Fu W, Okusanya OO, Goldberg KB, De Claro RA, Farrell AT, Pazdur R. Pulte ED, et al. Among authors: przepiorka d. Clin Cancer Res. 2021 Jul 1;27(13):3515-3521. doi: 10.1158/1078-0432.CCR-20-4271. Epub 2021 Feb 25. Clin Cancer Res. 2021. PMID: 33632926 Free PMC article. Clinical Trial.
FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy.
Jen EY, Wang X, Li M, Li H, Lee SL, Ni N, Przepiorka D, Vallejo J, Leong R, Ma L, Gehrke BJ, McLamore S, Theoret MR, de Claro RA. Jen EY, et al. Among authors: przepiorka d. Clin Cancer Res. 2022 Jul 15;28(14):2989-2993. doi: 10.1158/1078-0432.CCR-21-4525. Clin Cancer Res. 2022. PMID: 35325108 Free PMC article. Clinical Trial.
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: przepiorka d. 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: Blinatumomab.
Przepiorka D, Ko CW, Deisseroth A, Yancey CL, Candau-Chacon R, Chiu HJ, Gehrke BJ, Gomez-Broughton C, Kane RC, Kirshner S, Mehrotra N, Ricks TK, Schmiel D, Song P, Zhao P, Zhou Q, Farrell AT, Pazdur R. Przepiorka D, et al. Clin Cancer Res. 2015 Sep 15;21(18):4035-9. doi: 10.1158/1078-0432.CCR-15-0612. Clin Cancer Res. 2015. PMID: 26374073
204 results