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Page 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. Casak SJ, et al. Among authors: mckee ae. 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
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.
Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. Kim G, et al. Among authors: mckee ae. Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. Clin Cancer Res. 2015. PMID: 26187614 Review.
FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non-Small Cell Lung Cancer Following Crizotinib.
Larkins E, Blumenthal GM, Chen H, He K, Agarwal R, Gieser G, Stephens O, Zahalka E, Ringgold K, Helms W, Shord S, Yu J, Zhao H, Davis G, McKee AE, Keegan P, Pazdur R. Larkins E, et al. Among authors: mckee ae. Clin Cancer Res. 2016 Nov 1;22(21):5171-5176. doi: 10.1158/1078-0432.CCR-16-1293. Epub 2016 Jul 13. Clin Cancer Res. 2016. PMID: 27413075
FDA's Approach to Regulating Biosimilars.
Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R. Lemery SJ, et al. Among authors: mckee ae. 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: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.
Kim G, McKee AE, Ning YM, Hazarika M, Theoret M, Johnson JR, Xu QC, Tang S, Sridhara R, Jiang X, He K, Roscoe D, McGuinn WD, Helms WS, Russell AM, Miksinski SP, Zirkelbach JF, Earp J, Liu Q, Ibrahim A, Justice R, Pazdur R. Kim G, et al. Among authors: mckee ae. Clin Cancer Res. 2014 Oct 1;20(19):4994-5000. doi: 10.1158/1078-0432.CCR-14-0776. Epub 2014 Aug 5. Clin Cancer Res. 2014. PMID: 25096067 Review.
FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs.
Ison G, Beaver JA, McGuinn WD Jr, Palmby TR, Dinin J, Charlab R, Marathe A, Jin R, Liu Q, Chen XH, Ysern X, Stephens O, Bai G, Wang Y, Dorff SE, Cheng J, Tang S, Sridhara R, Pierce W, McKee AE, Ibrahim A, Kim G, Pazdur R. Ison G, et al. Among authors: mckee ae. Clin Cancer Res. 2016 Sep 15;22(18):4545-9. doi: 10.1158/1078-0432.CCR-16-0638. Epub 2016 Jul 11. Clin Cancer Res. 2016. PMID: 27401247 Review.
FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Walker AJ, Wedam S, Amiri-Kordestani L, Bloomquist E, Tang S, Sridhara R, Chen W, Palmby TR, Fourie Zirkelbach J, Fu W, Liu Q, Tilley A, Kim G, Kluetz PG, McKee AE, Pazdur R. Walker AJ, et al. Among authors: mckee ae. Clin Cancer Res. 2016 Oct 15;22(20):4968-4972. doi: 10.1158/1078-0432.CCR-16-0493. Epub 2016 Jul 12. Clin Cancer Res. 2016. PMID: 27407089
U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma.
Singh H, Brave M, Beaver JA, Cheng J, Tang S, Zahalka E, Palmby TR, Venugopal R, Song P, Liu Q, Liu C, Yu J, Chen XH, Wang X, Wang Y, Kluetz PG, Daniels SR, Papadopoulos EJ, Sridhara R, McKee AE, Ibrahim A, Kim G, Pazdur R. Singh H, et al. Among authors: mckee ae. Clin Cancer Res. 2017 Jan 15;23(2):330-335. doi: 10.1158/1078-0432.CCR-16-1073. Epub 2016 Oct 28. Clin Cancer Res. 2017. PMID: 27793960 Clinical Trial.
72 results