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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: shen yl. 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: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia.
Norsworthy KJ, By K, Subramaniam S, Zhuang L, Del Valle PL, Przepiorka D, Shen YL, Sheth CM, Liu C, Leong R, Goldberg KB, Farrell AT, Pazdur R. Norsworthy KJ, et al. Among authors: shen yl. Clin Cancer Res. 2019 Oct 15;25(20):6021-6025. doi: 10.1158/1078-0432.CCR-19-0365. Epub 2019 May 7. Clin Cancer Res. 2019. PMID: 31064779 Clinical Trial.
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: shen yl. 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.
FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.
Krauss AC, Gao X, Li L, Manning ML, Patel P, Fu W, Janoria KG, Gieser G, Bateman DA, Przepiorka D, Shen YL, Shord SS, Sheth CM, Banerjee A, Liu J, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R. Krauss AC, et al. Among authors: shen yl. Clin Cancer Res. 2019 May 1;25(9):2685-2690. doi: 10.1158/1078-0432.CCR-18-2990. Epub 2018 Dec 12. Clin Cancer Res. 2019. PMID: 30541745 Clinical Trial.
FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma.
Casak SJ, Donoghue M, Fashoyin-Aje L, Jiang X, Rodriguez L, Shen YL, Xu Y, Jiang X, Liu J, Zhao H, Pierce WF, Mehta S, Goldberg KB, Theoret MR, Kluetz PG, Pazdur R, Lemery SJ. Casak SJ, et al. Among authors: shen yl. Clin Cancer Res. 2021 Apr 1;27(7):1836-1841. doi: 10.1158/1078-0432.CCR-20-3407. Epub 2020 Nov 2. Clin Cancer Res. 2021. PMID: 33139264
External control arms in oncology: current use and future directions.
Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. Mishra-Kalyani PS, et al. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10. Ann Oncol. 2022. PMID: 35026413 Free article. Review.
392 results