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Items: 11

1.

FDA's Approval of the First Biosimilar to Bevacizumab.

Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY, Yuan W, Rodriguez L, Gwise T, Rowzee A, Lim S, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9.

PMID:
29743182
2.

When One Is a Hammer, Everything Looks Like a Nail.

Lemery SJ.

J Oncol Pract. 2017 Sep;13(9_suppl):10s-11s. doi: 10.1200/JOP.2017.026328. No abstract available.

PMID:
28898592
3.

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.

Clin Cancer Res. 2017 Jun 15;23(12):2924-2927. doi: 10.1158/1078-0432.CCR-16-2157. Epub 2017 Feb 17.

4.

FDA's Approach to Regulating Biosimilars.

Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2017 Apr 15;23(8):1882-1885. doi: 10.1158/1078-0432.CCR-16-1354. Epub 2016 Dec 29.

5.

Biosimilars: Here and Now.

Lemery SJ, Esteva FJ, Weise M.

Am Soc Clin Oncol Educ Book. 2016;35:e151-7. doi: 10.14694/EDBK_155954.

6.

FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer.

Nair A, Lemery SJ, Yang J, Marathe A, Zhao L, Zhao H, Jiang X, He K, Ladouceur G, Mitra AK, Zhou L, Fox E, Aungst S, Helms W, Keegan P, Pazdur R.

Clin Cancer Res. 2015 Dec 1;21(23):5205-8. doi: 10.1158/1078-0432.CCR-15-1377. Epub 2015 Aug 31.

7.

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.

Clin Cancer Res. 2015 Aug 1;21(15):3372-6. doi: 10.1158/1078-0432.CCR-15-0600. Epub 2015 Jun 5.

8.

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.

Clin Cancer Res. 2012 Mar 15;18(6):1496-505. doi: 10.1158/1078-0432.CCR-11-2149. Epub 2012 Jan 26.

9.

A pilot study evaluating the safety and CD34+ cell mobilizing activity of escalating doses of plerixafor in healthy volunteers.

Lemery SJ, Hsieh MM, Smith A, Rao S, Khuu HM, Theresa D, Viano JM, Cook L, Goodwin R, Boss C, Calandra G, Geller N, Tisdale J, Childs R.

Br J Haematol. 2011 Apr;153(1):66-75. doi: 10.1111/j.1365-2141.2010.08547.x. Epub 2011 Feb 24.

10.

U.S. Food and drug administration approval: rituximab in combination with fludarabine and cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia.

Casak SJ, Lemery SJ, Shen YL, Rothmann MD, Khandelwal A, Zhao H, Davis G, Jarral V, Keegan P, Pazdur R.

Oncologist. 2011;16(1):97-104. doi: 10.1634/theoncologist.2010-0306. Epub 2011 Jan 6. Review.

11.

U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.

Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, Keegan P, Pazdur R.

Clin Cancer Res. 2010 Sep 1;16(17):4331-8. doi: 10.1158/1078-0432.CCR-10-0570. Epub 2010 Jul 2.

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