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Year Number of Results
2015 2
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2020 2
2021 4
2022 2
2023 3
2024 3

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14 results

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Page 1
FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.
Fallah J, Brave MH, Weinstock C, Mehta GU, Bradford D, Gittleman H, Bloomquist EW, Charlab R, Hamed SS, Miller CP, Dorff SE, Chambers WA, Mixter BD, Dinin J, Pierce WF, Ricks TK, Tang S, Donoghue M, Pazdur R, Amiri-Kordestani L, Ibrahim A, Beaver JA. Fallah J, et al. Among authors: bradford d. Clin Cancer Res. 2022 Nov 14;28(22):4843-4848. doi: 10.1158/1078-0432.CCR-22-1054. Clin Cancer Res. 2022. PMID: 35727604 Free PMC article.
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Duke ES, Bradford D, Marcovitz M, Amatya AK, Mishra-Kalyani PS, Nguyen E, Price LSL, Fourie Zirkelbach J, Li Y, Bi Y, Kraft J, Dorff SE, Scepura B, Stephenson M, Ojofeitimi I, Nair A, Han Y, Tezak Z, Lemery SJ, Pazdur R, Larkins E, Singh H. Duke ES, et al. Among authors: bradford d. Clin Cancer Res. 2023 Sep 15;29(18):3573-3578. doi: 10.1158/1078-0432.CCR-23-0459. Clin Cancer Res. 2023. PMID: 37265412 Free PMC article. Clinical Trial.
Paediatric Strategy Forum for medicinal product development of DNA damage response pathway inhibitors in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson ADJ, Federico S, Gatz SA, Ortiz M, Lesa G, Scobie N, Gounaris I, Weiner SL, Weigel B, Unger TJ, Stewart E, Smith M, Slotkin EK, Reaman G, Pappo A, Nysom K, Norga K, McDonough J, Marshall LV, Ludwinski D, Ligas F, Karres D, Kool M, Horner TJ, Henssen A, Heenen D, Hawkins DS, Gore L, Bender JG, Galluzzo S, Fox E, de Rojas T, Davies BR, Chakrabarti J, Carmichael J, Bradford D, Blanc P, Bernardi R, Benchetrit S, Akindele K, Vassal G. Pearson ADJ, et al. Among authors: bradford d. Eur J Cancer. 2023 Sep;190:112950. doi: 10.1016/j.ejca.2023.112950. Epub 2023 Jun 21. Eur J Cancer. 2023. PMID: 37441939 Free article. Review.
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: bradford d. 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: Alpelisib for PIK3CA-Related Overgrowth Spectrum.
Singh S, Bradford D, Li X, Mishra-Kalyani PS, Shen YL, Wang L, Zhao H, Xiong Y, Liu J, Charlab R, Kraft J, Khasar S, Miller CP, Rivera DR, Kluetz PG, Pazdur R, Beaver JA, Singh H, Donoghue M. Singh S, et al. Among authors: bradford d. Clin Cancer Res. 2024 Jan 5;30(1):23-28. doi: 10.1158/1078-0432.CCR-23-1270. Clin Cancer Res. 2024. PMID: 37624421
FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma.
Barbato MI, Nashed J, Bradford D, Ren Y, Khasar S, Miller CP, Zolnik BS, Zhao H, Li Y, Bi Y, Shord SS, Amatya AK, Mishra-Kalyani PS, Scepura B, Al-Matari RA, Pazdur R, Kluetz PG, Donoghue M, Singh H, Drezner N. Barbato MI, et al. Among authors: bradford d. Clin Cancer Res. 2024 Jan 17;30(2):263-268. doi: 10.1158/1078-0432.CCR-23-1503. Clin Cancer Res. 2024. PMID: 37610803 Clinical Trial.
Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.
Pearson ADJ, Barry E, Mossé YP, Ligas F, Bird N, de Rojas T, Zimmerman ZF, Wilner K, Woessmann W, Weiner S, Weigel B, Venkatramani R, Valteau D, Trahair T, Smith M, Singh S, Selvaggi G, Scobie N, Schleiermacher G, Richardson N, Park J, Nysom K, Norga K, Merino M, McDonough J, Matloub Y, Marshall LV, Lowe E, Lesa G, Irwin M, Karres D, Gajjar A, Doz F, Fox E, DuBois SG, Donoghue M, Casanova M, Caron H, Buenger V, Bradford D, Blanc P, Barone A, Reaman G, Vassal G. Pearson ADJ, et al. Among authors: bradford d. Eur J Cancer. 2021 Nov;157:198-213. doi: 10.1016/j.ejca.2021.08.022. Epub 2021 Sep 15. Eur J Cancer. 2021. PMID: 34536944 Free article. Review.
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium.
Fangusaro J, Avery RA, Fisher MJ, Packer RJ, Walsh KS, Schouten-van Meeteren A, Karres D, Bradford D, Bhatnagar V, Singh H, Kluetz PG, Donoghue M, Duke ES. Fangusaro J, et al. Among authors: bradford d. Clin Cancer Res. 2024 Feb 15. doi: 10.1158/1078-0432.CCR-23-3386. Online ahead of print. Clin Cancer Res. 2024. PMID: 38358393
14 results