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Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD, Rossig C, Mackall C, Shah NN, Baruchel A, Reaman G, Ricafort R, Heenen D, Bassan A, Berntgen M, Bird N, Bleickardt E, Bouchkouj N, Bross P, Brownstein C, Cohen SB, de Rojas T, Ehrlich L, Fox E, Gottschalk S, Hanssens L, Hawkins DS, Horak ID, Taylor DH, Johnson C, Karres D, Ligas F, Ludwinski D, Mamonkin M, Marshall L, Masouleh BK, Matloub Y, Maude S, McDonough J, Minard-Colin V, Norga K, Nysom K, Pappo A, Pearce L, Pieters R, Pule M, Quintás-Cardama A, Richardson N, Schüßler-Lenz M, Scobie N, Sersch MA, Smith MA, Sterba J, Tasian SK, Weigel B, Weiner SL, Zwaan CM, Lesa G, Vassal G. Pearson AD, et al. Among authors: ehrlich l. Eur J Cancer. 2022 Jan;160:112-133. doi: 10.1016/j.ejca.2021.10.016. Epub 2021 Nov 25. Eur J Cancer. 2022. PMID: 34840026 Free article. Review.
Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.
Reaman G, Karres D, Ligas F, Lesa G, Casey D, Ehrlich L, Norga K, Pazdur R. Reaman G, et al. Among authors: ehrlich l. J Clin Oncol. 2020 Dec 20;38(36):4227-4230. doi: 10.1200/JCO.20.02152. Epub 2020 Sep 18. J Clin Oncol. 2020. PMID: 32946356 No abstract available.
Considerations for Drug Development in Myelodysplastic Syndromes.
Sekeres MA, Kim N, DeZern AE, Norsworthy KJ, Garcia JS, de Claro RA, Theoret MR, Jen EY, Ehrlich LA, Zeidan AM, Komrokji RS. Sekeres MA, et al. Clin Cancer Res. 2023 Jul 14;29(14):2573-2579. doi: 10.1158/1078-0432.CCR-22-3348. Clin Cancer Res. 2023. PMID: 36688922 Free PMC article.
FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes.
Kim N, Norsworthy KJ, Subramaniam S, Chen H, Manning ML, Kitabi E, Earp J, Ehrlich LA, Okusanya OO, Vallejo J, Gehrke BJ, de Claro RA, Pazdur R. Kim N, et al. Among authors: ehrlich la. Clin Cancer Res. 2022 Aug 15;28(16):3411-3416. doi: 10.1158/1078-0432.CCR-21-4498. Clin Cancer Res. 2022. PMID: 35435961 Free PMC article. Clinical Trial.
267 results