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Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a "physician's choice" control arm in a randomized approval trial.
Donoghue M, Lemery SJ, Yuan W, He K, Sridhara R, Shord S, Zhao H, Marathe A, Kotch L, Jee J, Wang Y, Zhou L, Adams WM, Jarral V, Pilaro A, Lostritto R, Gootenberg JE, Keegan P, Pazdur R. Donoghue M, et al. Among authors: lemery sj. Clin Cancer Res. 2012 Mar 15;18(6):1496-505. doi: 10.1158/1078-0432.CCR-11-2149. Epub 2012 Jan 26. Clin Cancer Res. 2012. PMID: 22282463
FDA Approval Summary: Ramucirumab for Gastric Cancer.
Casak SJ, Fashoyin-Aje I, Lemery SJ, Zhang L, Jin R, Li H, Zhao L, Zhao H, Zhang H, Chen H, He K, Dougherty M, Novak R, Kennett S, Khasar S, Helms W, Keegan P, Pazdur R. Casak SJ, et al. Among authors: lemery sj. Clin Cancer Res. 2015 Aug 1;21(15):3372-6. doi: 10.1158/1078-0432.CCR-15-0600. Epub 2015 Jun 5. Clin Cancer Res. 2015. PMID: 26048277 Clinical Trial.
FDA's Approach to Regulating Biosimilars.
Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R. Lemery SJ, et al. Clin Cancer Res. 2017 Apr 15;23(8):1882-1885. doi: 10.1158/1078-0432.CCR-16-1354. Epub 2016 Dec 29. Clin Cancer Res. 2017. PMID: 28034906
FDA Approval Summary: TAS-102.
Marcus L, Lemery SJ, Khasar S, Wearne E, Helms WS, Yuan W, He K, Cao X, Yu J, Zhao H, Wang Y, Stephens O, Englund E, Agarwal R, Keegan P, Pazdur R. Marcus L, et al. Among authors: lemery sj. Clin Cancer Res. 2017 Jun 15;23(12):2924-2927. doi: 10.1158/1078-0432.CCR-16-2157. Epub 2017 Feb 17. Clin Cancer Res. 2017. PMID: 28213365 Clinical Trial.
66 results