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FDA Approval Summary: Selumetinib for Plexiform Neurofibroma.
Casey D, Demko S, Sinha A, Mishra-Kalyani PS, Shen YL, Khasar S, Goheer MA, Helms WS, Pan L, Xu Y, Fan J, Leong R, Liu J, Yang Y, Windsor K, Ou M, Stephens O, Oh B, Reaman GH, Nair A, Shord SS, Bhatnagar V, Daniels SR, Sickafuse S, Goldberg KB, Theoret MR, Pazdur R, Singh H. Casey D, et al. Among authors: yang y. Clin Cancer Res. 2021 Aug 1;27(15):4142-4146. doi: 10.1158/1078-0432.CCR-20-5032. Epub 2021 Mar 12. Clin Cancer Res. 2021. PMID: 33712511
Model-Informed Drug Development in Pediatric Dose Selection.
Bi Y, Liu J, Li F, Yu J, Bhattaram A, Bewernitz M, Li RJ, Ahn J, Earp J, Ma L, Zhuang L, Yang Y, Zhang X, Zhu H, Wang Y. Bi Y, et al. Among authors: yang y. J Clin Pharmacol. 2021 Jun;61 Suppl 1:S60-S69. doi: 10.1002/jcph.1848. J Clin Pharmacol. 2021. PMID: 34185906 Review.
FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
Przepiorka D, Le RQ, Ionan A, Li RJ, Wang YH, Gudi R, Mitra S, Vallejo J, Okusanya OO, Ma L, Yang Y, Patel P, Mezaache D, Shah R, Banerjee A, McLamore S, Maung AN, Goldberg KB, Pazdur R, Theoret MR, De Claro RA. Przepiorka D, et al. Among authors: yang y. Clin Cancer Res. 2022 Jun 13;28(12):2488-2492. doi: 10.1158/1078-0432.CCR-21-4176. Clin Cancer Res. 2022. PMID: 35135839 Free PMC article.
FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Duke ES, Stapleford L, Drezner N, Amatya AK, Mishra-Kalyani PS, Shen YL, Maxfield K, Zirkelbach JF, Bi Y, Liu J, Zhang X, Wang H, Yang Y, Zheng N, Reece K, Wearne E, Glen JJ, Ojofeitimi I, Scepura B, Nair A, Bikkavilli RK, Ghosh S, Philip R, Pazdur R, Beaver JA, Singh H, Donoghue M. Duke ES, et al. Among authors: yang y. Clin Cancer Res. 2023 Feb 1;29(3):508-512. doi: 10.1158/1078-0432.CCR-22-2072. Clin Cancer Res. 2023. PMID: 36112541 Free PMC article. Clinical Trial.
FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement.
Patel TH, Marcus L, Horiba MN, Donoghue M, Chatterjee S, Mishra-Kalyani PS, Schuck RN, Li Y, Zhang X, Fourie Zirkelbach J, Charlab R, Liu J, Yang Y, Lemery SJ, Pazdur R, Theoret MR, Fashoyin-Aje LA. Patel TH, et al. Among authors: yang y. Clin Cancer Res. 2023 Mar 1;29(5):838-842. doi: 10.1158/1078-0432.CCR-22-2036. Clin Cancer Res. 2023. PMID: 36206041 Free PMC article.
FDA approval summary for lonafarnib (Zokinvy) for the treatment of Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies.
Suzuki M, Jeng LJB, Chefo S, Wang Y, Price D, Li X, Wang J, Li RJ, Ma L, Yang Y, Zhang X, Zheng N, Zhang K, Joseph DB, Shroff H, Doan J, Pacanowski M, Smpokou P, Donohue K, Joffe HV. Suzuki M, et al. Among authors: yang y. Genet Med. 2023 Feb;25(2):100335. doi: 10.1016/j.gim.2022.11.003. Epub 2022 Dec 12. Genet Med. 2023. PMID: 36507973 Free article.
FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer.
Fusco MJ, Casak SJ, Mushti SL, Cheng J, Christmas BJ, Thompson MD, Fu W, Wang H, Yoon M, Yang Y, Moore JN, Bi Y, Nan Y, Long CE, Auth D, Rahman NA, Tang S, Pazdur R, Fashoyin-Aje LA, Kluetz PG, Lemery SJ. Fusco MJ, et al. Among authors: yang y. Clin Cancer Res. 2024 May 29. doi: 10.1158/1078-0432.CCR-24-0281. Online ahead of print. Clin Cancer Res. 2024. PMID: 38809262
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