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FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer.
Casak SJ, Horiba MN, Yuan M, Cheng J, Lemery SJ, Shen YL, Fu W, Moore JN, Li Y, Bi Y, Auth D, Fesenko N, Kluetz PG, Pazdur R, Fashoyin-Aje LA. Casak SJ, et al. Among authors: lemery sj. Clin Cancer Res. 2023 Nov 1;29(21):4326-4330. doi: 10.1158/1078-0432.CCR-23-1041. Clin Cancer Res. 2023. PMID: 37318379 Free PMC article.
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. Casak SJ, et al. Among authors: lemery sj. Oncologist. 2011;16(1):97-104. doi: 10.1634/theoncologist.2010-0306. Epub 2011 Jan 6. Oncologist. 2011. PMID: 21212432 Free PMC article. Review.
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
53 results