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FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma.
Miller BW, Przepiorka D, de Claro RA, Lee K, Nie L, Simpson N, Gudi R, Saber H, Shord S, Bullock J, Marathe D, Mehrotra N, Hsieh LS, Ghosh D, Brown J, Kane RC, Justice R, Kaminskas E, Farrell AT, Pazdur R. Miller BW, et al. Among authors: lee k. Clin Cancer Res. 2015 Apr 1;21(7):1525-9. doi: 10.1158/1078-0432.CCR-14-2522. Epub 2015 Feb 2. Clin Cancer Res. 2015. PMID: 25645861
U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphoma.
de Claro RA, McGinn K, Kwitkowski V, Bullock J, Khandelwal A, Habtemariam B, Ouyang Y, Saber H, Lee K, Koti K, Rothmann M, Shapiro M, Borrego F, Clouse K, Chen XH, Brown J, Akinsanya L, Kane R, Kaminskas E, Farrell A, Pazdur R. de Claro RA, et al. Among authors: lee k. Clin Cancer Res. 2012 Nov 1;18(21):5845-9. doi: 10.1158/1078-0432.CCR-12-1803. Epub 2012 Sep 7. Clin Cancer Res. 2012. PMID: 22962441
Dose Finding in Late-Phase Drug Development.
Nie L, Lee KY, Verdun N, De Claro RA, Sridhara R. Nie L, et al. Ther Innov Regul Sci. 2017 Nov;51(6):738-743. doi: 10.1177/2168479017709297. Epub 2017 May 30. Ther Innov Regul Sci. 2017. PMID: 30227101
Missing data in biologic oncology products.
Rothmann MD, Koti K, Lee KY, Lu HL, Shen YL. Rothmann MD, et al. Among authors: lee ky. J Biopharm Stat. 2009 Nov;19(6):1074-84. doi: 10.1080/10543400903242993. J Biopharm Stat. 2009. PMID: 20183465
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