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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: shah a, shah m. 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: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer.
Shah M, Wedam S, Cheng J, Fiero MH, Xia H, Li F, Fan J, Zhang X, Yu J, Song P, Chen W, Ricks TK, Chen XH, Goldberg KB, Gong Y, Pierce WF, Tang S, Theoret MR, Pazdur R, Amiri-Kordestani L, Beaver JA. Shah M, et al. Clin Cancer Res. 2021 Mar 1;27(5):1220-1226. doi: 10.1158/1078-0432.CCR-20-2701. Epub 2020 Oct 14. Clin Cancer Res. 2021. PMID: 33055172
US Food and Drug Administration regulatory updates in neuro-oncology.
Mehta GU, Barone AK, Bradford D, Larkins E, Kim J, Pai-Scherf L, Jaigirdar A, Shah M, Wedam S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA, Singh H. Mehta GU, et al. Among authors: shah m. J Neurooncol. 2021 Jul;153(3):375-381. doi: 10.1007/s11060-021-03789-5. Epub 2021 Jun 22. J Neurooncol. 2021. PMID: 34156585 Free PMC article. Review.
The Drug-Dosing Conundrum in Oncology - When Less Is More.
Shah M, Rahman A, Theoret MR, Pazdur R. Shah M, et al. N Engl J Med. 2021 Oct 14;385(16):1445-1447. doi: 10.1056/NEJMp2109826. Epub 2021 Oct 9. N Engl J Med. 2021. PMID: 34623789 No abstract available.
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: shah m. 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: shah m. 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.
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: shah m. 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.
US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer.
Shah M, Lingam H, Gao X, Gittleman H, Fiero MH, Krol D, Biel N, Ricks TK, Fu W, Hamed S, Li F, Sun JJ, Fan J, Schuck R, Grimstein M, Tang L, Kalavar S, Abukhdeir A, Pathak A, Ghosh S, Bulatao I, Tilley A, Pierce WF, Mixter BD, Tang S, Pazdur R, Kluetz P, Amiri-Kordestani L. Shah M, et al. J Clin Oncol. 2024 Apr 1;42(10):1193-1201. doi: 10.1200/JCO.23.02112. Epub 2024 Feb 21. J Clin Oncol. 2024. PMID: 38381994 Clinical Trial.
7,386 results