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FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy.
Ison G, Howie LJ, Amiri-Kordestani L, Zhang L, Tang S, Sridhara R, Pierre V, Charlab R, Ramamoorthy A, Song P, Li F, Yu J, Manheng W, Palmby TR, Ghosh S, Horne HN, Lee EY, Philip R, Dave K, Chen XH, Kelly SL, Janoria KG, Banerjee A, Eradiri O, Dinin J, Goldberg KB, Pierce WF, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R. Ison G, et al. Among authors: yu j. Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12. Clin Cancer Res. 2018. PMID: 29650751
FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P. Beaver JA, et al. Among authors: yu j. Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31. Clin Cancer Res. 2015. PMID: 26324739 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: yu j. 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
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: yu j. 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.
FDA Approval Summary: TAS-102.
Marcus L, Lemery SJ, Khasar S, Wearne E, Helms WS, Yuan W, He K, Cao X, Yu J, Zhao H, Wang Y, Stephens O, Englund E, Agarwal R, Keegan P, Pazdur R. Marcus L, et al. Among authors: yu j. Clin Cancer Res. 2017 Jun 15;23(12):2924-2927. doi: 10.1158/1078-0432.CCR-16-2157. Epub 2017 Feb 17. Clin Cancer Res. 2017. PMID: 28213365 Clinical Trial.
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.
Larkins E, Blumenthal GM, Yuan W, He K, Sridhara R, Subramaniam S, Zhao H, Liu C, Yu J, Goldberg KB, McKee AE, Keegan P, Pazdur R. Larkins E, et al. Among authors: yu j. Oncologist. 2017 Jul;22(7):873-878. doi: 10.1634/theoncologist.2016-0496. Epub 2017 May 22. Oncologist. 2017. PMID: 28533473 Free PMC article.
Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response.
Li H, Yu J, Liu C, Liu J, Subramaniam S, Zhao H, Blumenthal GM, Turner DC, Li C, Ahamadi M, de Greef R, Chatterjee M, Kondic AG, Stone JA, Booth BP, Keegan P, Rahman A, Wang Y. Li H, et al. Among authors: yu j. J Pharmacokinet Pharmacodyn. 2017 Oct;44(5):403-414. doi: 10.1007/s10928-017-9528-y. Epub 2017 Jun 1. J Pharmacokinet Pharmacodyn. 2017. PMID: 28573468
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.
Balasubramaniam S, Beaver JA, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara R, Kim G, Pazdur R. Balasubramaniam S, et al. Among authors: yu j. Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27. Clin Cancer Res. 2017. PMID: 28751443
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