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Page 1
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Duke ES, Bradford D, Marcovitz M, Amatya AK, Mishra-Kalyani PS, Nguyen E, Price LSL, Fourie Zirkelbach J, Li Y, Bi Y, Kraft J, Dorff SE, Scepura B, Stephenson M, Ojofeitimi I, Nair A, Han Y, Tezak Z, Lemery SJ, Pazdur R, Larkins E, Singh H. Duke ES, et al. Among authors: lemery sj. Clin Cancer Res. 2023 Sep 15;29(18):3573-3578. doi: 10.1158/1078-0432.CCR-23-0459. Clin Cancer Res. 2023. PMID: 37265412 Free PMC article. 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
Tissue-Agnostic Drug Development.
Flaherty KT, Le DT, Lemery S. Flaherty KT, et al. Among authors: lemery s. Am Soc Clin Oncol Educ Book. 2017;37:222-230. doi: 10.1200/EDBK_173855. Am Soc Clin Oncol Educ Book. 2017. PMID: 28561648 Free article.
Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration-Melanoma Research Alliance Public Workshop.
Mueller KL, Theoret MR, Lemery SJ, Amiri-Kordestani L, Ariyan CE, Atkins MB, Berry DA, Blank CU, DeMichele AM, Forde PM, Ibrahim N, Keegan P, Mitchell TC, Moss RA, Robert C, Sridhara R, Taube JM, Tetzlaff MT, Wargo JA, Flaherty KT, Kaplan MJ, Topalian SL, Ward AF, Hurlbert MS. Mueller KL, et al. Among authors: lemery sj. Clin Cancer Res. 2021 Jan 15;27(2):394-401. doi: 10.1158/1078-0432.CCR-20-3285. Epub 2020 Nov 13. Clin Cancer Res. 2021. PMID: 33188142 Review.
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. Casak SJ, et al. Among authors: lemery sj. Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9. Clin Cancer Res. 2018. PMID: 29743182
67 results