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64 results

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Page 1
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: charlab r. Clin Cancer Res. 2024 Oct 30. doi: 10.1158/1078-0432.CCR-24-2196. Online ahead of print. Clin Cancer Res. 2024. PMID: 39475462
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: charlab r. 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: charlab r. 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: 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: charlab r. 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: charlab r. 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: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions.
Bradford D, Larkins E, Mushti SL, Rodriguez L, Skinner AM, Helms WS, Price LSL, Zirkelbach JF, Li Y, Liu J, Charlab R, Turcu FR, Liang D, Ghosh S, Roscoe D, Philip R, Zack-Taylor A, Tang S, Kluetz PG, Beaver JA, Pazdur R, Theoret MR, Singh H. Bradford D, et al. Among authors: charlab r. Clin Cancer Res. 2021 Apr 15;27(8):2130-2135. doi: 10.1158/1078-0432.CCR-20-3558. Epub 2020 Nov 25. Clin Cancer Res. 2021. PMID: 33239432
FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions.
Kim J, Bradford D, Larkins E, Pai-Scherf LH, Chatterjee S, Mishra-Kalyani PS, Wearne E, Helms WS, Ayyoub A, Bi Y, Sun J, Charlab R, Liu J, Zhao H, Liang D, Ghosh S, Philip R, Pazdur R, Theoret MR, Beaver JA, Singh H. Kim J, et al. Among authors: charlab r. Clin Cancer Res. 2021 Oct 15;27(20):5452-5456. doi: 10.1158/1078-0432.CCR-21-0967. Epub 2021 May 27. Clin Cancer Res. 2021. PMID: 34045295
FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation.
Casak SJ, Pradhan S, Fashoyin-Aje LA, Ren Y, Shen YL, Xu Y, Chow ECY, Xiong Y, Zirklelbach JF, Liu J, Charlab R, Pierce WF, Fesenko N, Beaver JA, Pazdur R, Kluetz PG, Lemery SJ. Casak SJ, et al. Among authors: charlab r. Clin Cancer Res. 2022 Jul 1;28(13):2733-2737. doi: 10.1158/1078-0432.CCR-21-4462. Clin Cancer Res. 2022. PMID: 35259259 Free PMC article. Clinical Trial.
FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement.
Patel TH, Marcus L, Horiba MN, Donoghue M, Chatterjee S, Mishra-Kalyani PS, Schuck RN, Li Y, Zhang X, Fourie Zirkelbach J, Charlab R, Liu J, Yang Y, Lemery SJ, Pazdur R, Theoret MR, Fashoyin-Aje LA. Patel TH, et al. Among authors: charlab r. Clin Cancer Res. 2023 Mar 1;29(5):838-842. doi: 10.1158/1078-0432.CCR-22-2036. Clin Cancer Res. 2023. PMID: 36206041 Free PMC article.
FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor.
Kumar V, Doros L, Thompson M, Mushti SL, Charlab R, Spehalski EI, Zhao H, Thompson MD, Tang S, Pazdur R, Lemery SJ, Theoret MR, Fashoyin-Aje LA. Kumar V, et al. Among authors: charlab r. Clin Cancer Res. 2023 Jun 1;29(11):2020-2024. doi: 10.1158/1078-0432.CCR-22-2400. Clin Cancer Res. 2023. PMID: 36485007 Free PMC article. Clinical Trial.
64 results