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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: kluetz pg. 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
FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs.
Kluetz PG, Keegan P, Demetri GD, Thornton K, Sul J, Kim J, Katzen H, Burke LB, Harvey RD, Alebachew E, Agrawal S, Nair A, Donoghue M, Pierce WF, Shord SS, Gao JJ, Pazdur R. Kluetz PG, et al. Clin Cancer Res. 2021 Feb 15;27(4):916-921. doi: 10.1158/1078-0432.CCR-20-3213. Epub 2020 Nov 30. Clin Cancer Res. 2021. PMID: 33257426
The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology.
Schneider JA, Gong Y, Goldberg KB, Kluetz PG, Theoret MR, Amiri-Kordestani L, Beaver JA, Fashoyin-Aje L, Gormley NJ, Jaigirdar AA, Lemery SJ, Mishra-Kalyani PS, Reaman GH, Rivera DR, Rubinstein WS, Singh H, Sridhara R, Pazdur R. Schneider JA, et al. Among authors: kluetz pg. Clin Cancer Res. 2021 Oct 1;27(19):5161-5167. doi: 10.1158/1078-0432.CCR-20-4429. Clin Cancer Res. 2021. PMID: 33910935 Free PMC article.
Rapid real-world data analysis of patients with cancer, with and without COVID-19, across distinct health systems.
Hwang C, Izano MA, Thompson MA, Gadgeel SM, Weese JL, Mikkelsen T, Schrag A, Teka M, Walters S, Wolf FM, Hirsch J, Rivera DR, Kluetz PG, Singh H, Brown TD. Hwang C, et al. Among authors: kluetz pg. Cancer Rep (Hoboken). 2021 Oct;4(5):e1388. doi: 10.1002/cnr2.1388. Epub 2021 May 20. Cancer Rep (Hoboken). 2021. PMID: 34014037 Free PMC article.
ASH Research Collaborative: a real-world data infrastructure to support real-world evidence development and learning healthcare systems in hematology.
Wood WA, Marks P, Plovnick RM, Hewitt K, Neuberg DS, Walters S, Dolan BK, Tucker EA, Abrams CS, Thompson AA, Anderson KC, Kluetz P, Farrell A, Rivera D, Gertzog M, Pappas G. Wood WA, et al. Blood Adv. 2021 Dec 14;5(23):5429-5438. doi: 10.1182/bloodadvances.2021005902. Blood Adv. 2021. PMID: 34673922 Free PMC article.
External control arms in oncology: current use and future directions.
Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. Mishra-Kalyani PS, et al. Among authors: kluetz pg. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10. Ann Oncol. 2022. PMID: 35026413 Free article. Review.
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