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FDA Approval Summary: Selumetinib for Plexiform Neurofibroma.
Casey D, Demko S, Sinha A, Mishra-Kalyani PS, Shen YL, Khasar S, Goheer MA, Helms WS, Pan L, Xu Y, Fan J, Leong R, Liu J, Yang Y, Windsor K, Ou M, Stephens O, Oh B, Reaman GH, Nair A, Shord SS, Bhatnagar V, Daniels SR, Sickafuse S, Goldberg KB, Theoret MR, Pazdur R, Singh H. Casey D, et al. Among authors: singh h. Clin Cancer Res. 2021 Aug 1;27(15):4142-4146. doi: 10.1158/1078-0432.CCR-20-5032. Epub 2021 Mar 12. Clin Cancer Res. 2021. PMID: 33712511
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. 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.
Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.
Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG. Kim J, et al. Among authors: singh h. Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555. Epub 2017 Dec 13. Clin Cancer Res. 2018. PMID: 29237718 Review.
U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.
Singh H, Walker AJ, Amiri-Kordestani L, Cheng J, Tang S, Balcazar P, Barnett-Ringgold K, Palmby TR, Cao X, Zheng N, Liu Q, Yu J, Pierce WF, Daniels SR, Sridhara R, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R. Singh H, et al. Clin Cancer Res. 2018 Aug 1;24(15):3486-3491. doi: 10.1158/1078-0432.CCR-17-3628. Epub 2018 Mar 9. Clin Cancer Res. 2018. PMID: 29523624 Clinical Trial.
Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody.
Maher VE, Fernandes LL, Weinstock C, Tang S, Agarwal S, Brave M, Ning YM, Singh H, Suzman D, Xu J, Goldberg KB, Sridhara R, Ibrahim A, Theoret M, Beaver JA, Pazdur R. Maher VE, et al. Among authors: singh h. J Clin Oncol. 2019 Oct 20;37(30):2730-2737. doi: 10.1200/JCO.19.00318. Epub 2019 May 22. J Clin Oncol. 2019. PMID: 31116675
Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.
Howie LJ, Singh H, Bloomquist E, Wedam S, Amiri-Kordestani L, Tang S, Sridhara R, Sanchez J, Prowell TM, Kluetz PG, King-Kallimanis BL, Gao JJ, Ibrahim A, Goldberg KB, Theoret M, Pazdur R, Beaver JA. Howie LJ, et al. Among authors: singh h. J Clin Oncol. 2019 Dec 20;37(36):3475-3483. doi: 10.1200/JCO.18.02217. Epub 2019 Sep 27. J Clin Oncol. 2019. PMID: 31560580
7,257 results