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Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary.
Malik SM, Liu K, Qiang X, Sridhara R, Tang S, McGuinn WD Jr, Verbois SL, Marathe A, Williams GM, Bullock J, Tornoe C, Lin SC, Ocheltree T, Vialpando M, Kacuba A, Justice R, Pazdur R. Malik SM, et al. Among authors: marathe a. Clin Cancer Res. 2010 Oct 15;16(20):4921-7. doi: 10.1158/1078-0432.CCR-10-1214. Epub 2010 Aug 25. Clin Cancer Res. 2010. PMID: 20739433 Review.
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, Jadhav PR, Krudys K, Lesko LJ, Li F, Liu J, Madabushi R, Marathe A, Mehrotra N, Tornoe C, Wang Y, Zhu H. Lee JY, et al. Among authors: marathe a. Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000. Clin Pharmacokinet. 2011. PMID: 21895036
U.S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive.
Malik SM, Maher VE, Bijwaard KE, Becker RL, Zhang L, Tang SW, Song P, Liu Q, Marathe A, Gehrke B, Helms W, Hanner D, Justice R, Pazdur R. Malik SM, et al. Among authors: marathe a. Clin Cancer Res. 2014 Apr 15;20(8):2029-34. doi: 10.1158/1078-0432.CCR-13-3077. Epub 2014 Feb 26. Clin Cancer Res. 2014. PMID: 24573551
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: marathe a. 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.
162 results