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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: tang s. 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.
Sorafenib for the treatment of advanced renal cell carcinoma.
Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R. Kane RC, et al. Among authors: tang s. Clin Cancer Res. 2006 Dec 15;12(24):7271-8. doi: 10.1158/1078-0432.CCR-06-1249. Clin Cancer Res. 2006. PMID: 17189398 Review.
Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma.
Goodman VL, Rock EP, Dagher R, Ramchandani RP, Abraham S, Gobburu JV, Booth BP, Verbois SL, Morse DE, Liang CY, Chidambaram N, Jiang JX, Tang S, Mahjoob K, Justice R, Pazdur R. Goodman VL, et al. Among authors: tang s. Clin Cancer Res. 2007 Mar 1;13(5):1367-73. doi: 10.1158/1078-0432.CCR-06-2328. Clin Cancer Res. 2007. PMID: 17332278 Review.
Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary.
Malik SM, Liu K, Qiang X, Sridhara R, Tang S, McGuinn WD Jr, Verbois SL, Marathe A, Williams GM, Bullock J, Tornoe C, Lin SC, Ocheltree T, Vialpando M, Kacuba A, Justice R, Pazdur R. Malik SM, et al. Among authors: tang s. Clin Cancer Res. 2010 Oct 15;16(20):4921-7. doi: 10.1158/1078-0432.CCR-10-1214. Epub 2010 Aug 25. Clin Cancer Res. 2010. PMID: 20739433 Review.
Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.
Thornton K, Kim G, Maher VE, Chattopadhyay S, Tang S, Moon YJ, Song P, Marathe A, Balakrishnan S, Zhu H, Garnett C, Liu Q, Booth B, Gehrke B, Dorsam R, Verbois L, Ghosh D, Wilson W, Duan J, Sarker H, Miksinski SP, Skarupa L, Ibrahim A, Justice R, Murgo A, Pazdur R. Thornton K, et al. Among authors: tang s. Clin Cancer Res. 2012 Jul 15;18(14):3722-30. doi: 10.1158/1078-0432.CCR-12-0411. Epub 2012 Jun 4. Clin Cancer Res. 2012. PMID: 22665903 Clinical Trial.
Overestimation of the effect size in group sequential trials.
Zhang JJ, Blumenthal GM, He K, Tang S, Cortazar P, Sridhara R. Zhang JJ, et al. Among authors: tang s. Clin Cancer Res. 2012 Sep 15;18(18):4872-6. doi: 10.1158/1078-0432.CCR-11-3118. Epub 2012 Jul 2. Clin Cancer Res. 2012. PMID: 22753584
First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer.
Blumenthal GM, Scher NS, Cortazar P, Chattopadhyay S, Tang S, Song P, Liu Q, Ringgold K, Pilaro AM, Tilley A, King KE, Graham L, Rellahan BL, Weinberg WC, Chi B, Thomas C, Hughes P, Ibrahim A, Justice R, Pazdur R. Blumenthal GM, et al. Among authors: tang s. Clin Cancer Res. 2013 Sep 15;19(18):4911-6. doi: 10.1158/1078-0432.CCR-13-1212. Epub 2013 Jun 25. Clin Cancer Res. 2013. PMID: 23801166
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.
Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, Palmby T, Pfuma E, Zirkelbach JF, Mehrotra N, Tilley A, Sridhara R, Ibrahim A, Justice R, Pazdur R. Kluetz PG, et al. Among authors: tang s. Clin Cancer Res. 2013 Dec 15;19(24):6650-6. doi: 10.1158/1078-0432.CCR-13-2134. Epub 2013 Oct 22. Clin Cancer Res. 2013. PMID: 24150234 Clinical Trial.
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