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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. Among authors: jaigirdar a. 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.
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.
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.
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.
Preferential priming of alloreactive T cells with indirect reactivity.
Brennan TV, Jaigirdar A, Hoang V, Hayden T, Liu FC, Zaid H, Chang CK, Bucy RP, Tang Q, Kang SM. Brennan TV, et al. Among authors: jaigirdar a. Am J Transplant. 2009 Apr;9(4):709-18. doi: 10.1111/j.1600-6143.2009.02578.x. Am J Transplant. 2009. PMID: 19344462 Free PMC article.
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