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Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy.
Pelosof L, Saung MT, Donoghue M, Casak S, Mushti S, Cheng J, Jiang X, Liu J, Zhao H, Khazraee M, Goldberg KB, Theoret M, Lemery S, Pazdur R, Fashoyin-Aje L. Pelosof L, et al. Oncologist. 2021 Apr;26(4):318-324. doi: 10.1002/onco.13646. Epub 2021 Jan 11. Oncologist. 2021. PMID: 33345396 Free PMC article. Clinical Trial.
FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma.
Casak SJ, Donoghue M, Fashoyin-Aje L, Jiang X, Rodriguez L, Shen YL, Xu Y, Jiang X, Liu J, Zhao H, Pierce WF, Mehta S, Goldberg KB, Theoret MR, Kluetz PG, Pazdur R, Lemery SJ. Casak SJ, et al. Clin Cancer Res. 2021 Apr 1;27(7):1836-1841. doi: 10.1158/1078-0432.CCR-20-3407. Epub 2020 Nov 2. Clin Cancer Res. 2021. PMID: 33139264
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer.
Wahby S, Fashoyin-Aje L, Osgood CL, Cheng J, Fiero MH, Zhang L, Tang S, Hamed SS, Song P, Charlab R, Dorff SE, Ricks TK, Barnett-Ringgold K, Dinin J, Goldberg KB, Theoret MR, Pazdur R, Amiri-Kordestani L, Beaver JA. Wahby S, et al. Clin Cancer Res. 2021 Apr 1;27(7):1850-1854. doi: 10.1158/1078-0432.CCR-20-3119. Epub 2020 Nov 9. Clin Cancer Res. 2021. PMID: 33168656 Clinical Trial.
FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma.
Casak SJ, Marcus L, Fashoyin-Aje L, Mushti SL, Cheng J, Shen YL, Pierce WF, Her L, Goldberg KB, Theoret MR, Kluetz PG, Pazdur R, Lemery SJ. Casak SJ, et al. Clin Cancer Res. 2021 Sep 1;27(17):4680-4684. doi: 10.1158/1078-0432.CCR-21-0557. Epub 2021 Apr 12. Clin Cancer Res. 2021. PMID: 33846198 Free PMC article. Clinical Trial.
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. 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.
Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria.
Gao JJ, Krol D, Narayan P, Cardoso F, Regan MM, Goetz MP, Hurvitz SA, Mauro L, Hodgdon C, Miller CP, Booth B, Bloomquist E, Ison G, Osgood C, Bhatnagar V, Fashoyin-Aje L, Pazdur R, Amiri-Kordestani L, Beaver JA. Gao JJ, et al. Ann Oncol. 2021 Aug;32(8):950-953. doi: 10.1016/j.annonc.2021.05.356. Epub 2021 May 13. Ann Oncol. 2021. PMID: 33991601 Free article. No abstract available.
59 results