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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. 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.
Why do phase III clinical trials in oncology fail so often?
Amiri-Kordestani L, Fojo T. Amiri-Kordestani L, et al. J Natl Cancer Inst. 2012 Apr 18;104(8):568-9. doi: 10.1093/jnci/djs180. Epub 2012 Apr 6. J Natl Cancer Inst. 2012. PMID: 22491346 No abstract available.
The TRAIL receptor agonist drozitumab targets basal B triple-negative breast cancer cells that express vimentin and Axl.
Dine JL, O'Sullivan CC, Voeller D, Greer YE, Chavez KJ, Conway CM, Sinclair S, Stone B, Amiri-Kordestani L, Merchant AS, Hewitt SM, Steinberg SM, Swain SM, Lipkowitz S. Dine JL, et al. Breast Cancer Res Treat. 2016 Jan;155(2):235-51. doi: 10.1007/s10549-015-3673-z. Epub 2016 Jan 12. Breast Cancer Res Treat. 2016. PMID: 26759246 Free PMC article.
FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.
Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P. Amiri-Kordestani L, et al. Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30. Clin Cancer Res. 2014. PMID: 24879797 Clinical Trial.
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