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FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.
de Claro RA, McGinn KM, Verdun N, Lee SL, Chiu HJ, Saber H, Brower ME, Chang CJ, Pfuma E, Habtemariam B, Bullock J, Wang Y, Nie L, Chen XH, Lu DR, Al-Hakim A, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. de Claro RA, et al. Among authors: lee sl. Clin Cancer Res. 2015 Aug 15;21(16):3586-90. doi: 10.1158/1078-0432.CCR-14-2225. Clin Cancer Res. 2015. PMID: 26275952
Approval summary for bortezomib for injection in the treatment of multiple myeloma.
Bross PF, Kane R, Farrell AT, Abraham S, Benson K, Brower ME, Bradley S, Gobburu JV, Goheer A, Lee SL, Leighton J, Liang CY, Lostritto RT, McGuinn WD, Morse DE, Rahman A, Rosario LA, Verbois SL, Williams G, Wang YC, Pazdur R. Bross PF, et al. Among authors: lee sl. Clin Cancer Res. 2004 Jun 15;10(12 Pt 1):3954-64. doi: 10.1158/1078-0432.CCR-03-0781. Clin Cancer Res. 2004. PMID: 15217925 Clinical Trial. No abstract available.
Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes.
Kaminskas E, Farrell A, Abraham S, Baird A, Hsieh LS, Lee SL, Leighton JK, Patel H, Rahman A, Sridhara R, Wang YC, Pazdur R; FDA. Kaminskas E, et al. Among authors: lee sl. Clin Cancer Res. 2005 May 15;11(10):3604-8. doi: 10.1158/1078-0432.CCR-04-2135. Clin Cancer Res. 2005. PMID: 15897554 Clinical Trial.
Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.
Hazarika M, Jiang X, Liu Q, Lee SL, Ramchandani R, Garnett C, Orr MS, Sridhara R, Booth B, Leighton JK, Timmer W, Harapanhalli R, Dagher R, Justice R, Pazdur R. Hazarika M, et al. Among authors: lee sl. Clin Cancer Res. 2008 Sep 1;14(17):5325-31. doi: 10.1158/1078-0432.CCR-08-0308. Clin Cancer Res. 2008. PMID: 18765523
FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy.
Jen EY, Wang X, Li M, Li H, Lee SL, Ni N, Przepiorka D, Vallejo J, Leong R, Ma L, Gehrke BJ, McLamore S, Theoret MR, de Claro RA. Jen EY, et al. Among authors: lee sl. Clin Cancer Res. 2022 Jul 15;28(14):2989-2993. doi: 10.1158/1078-0432.CCR-21-4525. Clin Cancer Res. 2022. PMID: 35325108 Free PMC article. Clinical Trial.
FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation.
Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R. Brave M, et al. Among authors: lee sl. Oncology. 2010;78(3-4):282-8. doi: 10.1159/000315736. Epub 2010 Jun 8. Oncology. 2010. PMID: 20530974
An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).
Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. Avila AM, et al. Among authors: lee sl. Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. Regul Toxicol Pharmacol. 2020. PMID: 32325112
Minimizing Risks of Appendectomy.
Minneci PC, Asti L, Lee SL. Minneci PC, et al. Among authors: lee sl. J Pediatr Surg. 2024 May 6:S0022-3468(24)00299-9. doi: 10.1016/j.jpedsurg.2024.04.022. Online ahead of print. J Pediatr Surg. 2024. PMID: 38806316 No abstract available.
1,327 results