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Page 1
FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.
Dilawari A, Shah M, Ison G, Gittleman H, Fiero MH, Shah A, Hamed SS, Qiu J, Yu J, Manheng W, Ricks TK, Pragani R, Arudchandran A, Patel P, Zaman S, Roy A, Kalavar S, Ghosh S, Pierce WF, Rahman NA, Tang S, Mixter BD, Kluetz PG, Pazdur R, Amiri-Kordestani L. Dilawari A, et al. Among authors: ison g. Clin Cancer Res. 2023 Oct 2;29(19):3835-3840. doi: 10.1158/1078-0432.CCR-23-0991. Clin Cancer Res. 2023. PMID: 37212825 Free PMC article.
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.
Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. Kim G, et al. Among authors: ison g. Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. Clin Cancer Res. 2015. PMID: 26187614 Review.
FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy.
Ison G, Howie LJ, Amiri-Kordestani L, Zhang L, Tang S, Sridhara R, Pierre V, Charlab R, Ramamoorthy A, Song P, Li F, Yu J, Manheng W, Palmby TR, Ghosh S, Horne HN, Lee EY, Philip R, Dave K, Chen XH, Kelly SL, Janoria KG, Banerjee A, Eradiri O, Dinin J, Goldberg KB, Pierce WF, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R. Ison G, et al. Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12. Clin Cancer Res. 2018. PMID: 29650751
U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review.
Arora S, Narayan P, Ison G, Berman T, Suzman DL, Wedam S, Prowell TM, Ghosh S, Philip R, Osgood CL, Gao JJ, Shah M, Krol D, Wahby S, Royce M, Brus C, Bloomquist EW, Fiero MH, Tang S, Pazdur R, Ibrahim A, Amiri-Kordestani L, Beaver JA. Arora S, et al. Among authors: ison g. Clin Cancer Res. 2022 Mar 15;28(6):1058-1071. doi: 10.1158/1078-0432.CCR-21-2599. Clin Cancer Res. 2022. PMID: 34711631 Free PMC article. Review.
U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.
Arora S, Narayan P, Osgood CL, Wedam S, Prowell TM, Gao JJ, Shah M, Krol D, Wahby S, Royce M, Ghosh S, Philip R, Ison G, Berman T, Brus C, Bloomquist EW, Fiero MH, Tang S, Pazdur R, Ibrahim A, Amiri-Kordestani L, Beaver JA. Arora S, et al. Among authors: ison g. Clin Cancer Res. 2022 Mar 15;28(6):1072-1086. doi: 10.1158/1078-0432.CCR-21-2600. Clin Cancer Res. 2022. PMID: 34711632 Free PMC article. Review.
FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs.
Ison G, Beaver JA, McGuinn WD Jr, Palmby TR, Dinin J, Charlab R, Marathe A, Jin R, Liu Q, Chen XH, Ysern X, Stephens O, Bai G, Wang Y, Dorff SE, Cheng J, Tang S, Sridhara R, Pierce W, McKee AE, Ibrahim A, Kim G, Pazdur R. Ison G, et al. Clin Cancer Res. 2016 Sep 15;22(18):4545-9. doi: 10.1158/1078-0432.CCR-16-0638. Epub 2016 Jul 11. Clin Cancer Res. 2016. PMID: 27401247 Review.
Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients.
Fourie Zirkelbach J, Shah M, Vallejo J, Cheng J, Ayyoub A, Liu J, Hudson R, Sridhara R, Ison G, Amiri-Kordestani L, Tang S, Gwise T, Rahman A, Pazdur R, Theoret MR. Fourie Zirkelbach J, et al. Among authors: ison g. J Clin Oncol. 2022 Oct 20;40(30):3489-3500. doi: 10.1200/JCO.22.00371. Epub 2022 Sep 12. J Clin Oncol. 2022. PMID: 36095296 Review.
Successes and Challenges of PARP Inhibitors in Cancer Therapy.
Ricks TK, Chiu HJ, Ison G, Kim G, McKee AE, Kluetz P, Pazdur R. Ricks TK, et al. Among authors: ison g. Front Oncol. 2015 Oct 14;5:222. doi: 10.3389/fonc.2015.00222. eCollection 2015. Front Oncol. 2015. PMID: 26528434 Free PMC article. Review. No abstract available.
Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.
Gao JJ, Cheng J, Prowell TM, Bloomquist E, Tang S, Wedam SB, Royce M, Krol D, Osgood C, Ison G, Sridhara R, Pazdur R, Beaver JA, Amiri-Kordestani L. Gao JJ, et al. Among authors: ison g. Lancet Oncol. 2021 Nov;22(11):1573-1581. doi: 10.1016/S1470-2045(21)00472-1. Epub 2021 Oct 14. Lancet Oncol. 2021. PMID: 34656225
29 results