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Page 1
Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer.
Chang E, Hahn NM, Lerner SP, Fallah J, Agrawal S, Kamat AM, Bhatnagar V, Svatek RS, Jaigirdar AA, Bross P, Shore N, Kates M, Sachse K, Brewer JR, O'Donnell MA, Steinberg GD, Viviano CJ, Bloomquist E, Ribal MJ, Galsky MD, Oliver R, Black PC, Al-Ahmadie H, Brothers K, Pohar K, Dinney CP, Feng Z, Downs TM, Porten SP, Smith AB, Bangs R, Psutka SP, Agarwal N, Amiri-Kordestani L, Suzman DL, Pazdur R, Kluetz PG, Weinstock C. Chang E, et al. Among authors: jaigirdar aa. Bladder Cancer. 2023 Sep 25;9(3):271-286. doi: 10.3233/BLC-230056. eCollection 2023. Bladder Cancer. 2023. PMID: 38993184 Free PMC article.
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: jaigirdar aa. 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.
US Food and Drug Administration regulatory updates in neuro-oncology.
Mehta GU, Barone AK, Bradford D, Larkins E, Kim J, Pai-Scherf L, Jaigirdar A, Shah M, Wedam S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA, Singh H. Mehta GU, et al. J Neurooncol. 2021 Jul;153(3):375-381. doi: 10.1007/s11060-021-03789-5. Epub 2021 Jun 22. J Neurooncol. 2021. PMID: 34156585 Free PMC article. Review.
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer.
Singh S, Jaigirdar AA, Mulkey F, Cheng J, Hamed SS, Li Y, Liu J, Zhao H, Goheer A, Helms WS, Wang X, Agarwal R, Pragani R, Korsah K, Tang S, Leighton J, Rahman A, Beaver JA, Pazdur R, Theoret MR, Singh H. Singh S, et al. Among authors: jaigirdar aa. Clin Cancer Res. 2021 May 1;27(9):2378-2382. doi: 10.1158/1078-0432.CCR-20-3901. Epub 2020 Dec 7. Clin Cancer Res. 2021. PMID: 33288660 Free PMC article.
FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review.
Vellanki PJ, Mulkey F, Jaigirdar AA, Rodriguez L, Wang Y, Xu Y, Zhao H, Liu J, Howe G, Wang J, Choo Q, Golding SJ, Mansell V, Korsah K, Spillman D, de Claro RA, Pazdur R, Beaver JA, Singh H. Vellanki PJ, et al. Among authors: jaigirdar aa. Clin Cancer Res. 2021 Jul 1;27(13):3522-3527. doi: 10.1158/1078-0432.CCR-20-4338. Epub 2021 Feb 25. Clin Cancer Res. 2021. PMID: 33632925 Free PMC article. Clinical Trial.