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FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation.
Woods AC, Norsworthy KJ, Choe M, Gehrke BJ, Chen H, Vallejo J, Pan L, Jiang X, Li H, Kraft J, Liu J, Charlab R, Okusanya OO, Booth B, Pazdur R, Theoret MR, de Claro RA. Woods AC, et al. Among authors: de claro ra. Clin Cancer Res. 2024 Oct 30. doi: 10.1158/1078-0432.CCR-24-2196. Online ahead of print. Clin Cancer Res. 2024. PMID: 39475462
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
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: de claro ra. 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.
52 results