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205 results

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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: przepiorka d. 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
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: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
Przepiorka D, Le RQ, Ionan A, Li RJ, Wang YH, Gudi R, Mitra S, Vallejo J, Okusanya OO, Ma L, Yang Y, Patel P, Mezaache D, Shah R, Banerjee A, McLamore S, Maung AN, Goldberg KB, Pazdur R, Theoret MR, De Claro RA. Przepiorka D, et al. Clin Cancer Res. 2022 Jun 13;28(12):2488-2492. doi: 10.1158/1078-0432.CCR-21-4176. Clin Cancer Res. 2022. PMID: 35135839 Free PMC article.
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
205 results