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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements.
Gandhy SU, Casak SJ, Mushti SL, Cheng J, Subramaniam S, Zhao H, Zhao M, Bi Y, Liu G, Fan J, Adeniyi O, Charlab R, Kufrin D, Thompson MD, Jarrell K, Auth D, Lemery SJ, Pazdur R, Kluetz PG, Fashoyin-Aje LA. Gandhy SU, et al. Among authors: zhao h, zhao m. Clin Cancer Res. 2023 Oct 13;29(20):4027-4031. doi: 10.1158/1078-0432.CCR-23-1042. Clin Cancer Res. 2023. PMID: 37289037 Free PMC article.
FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor.
Kumar V, Doros L, Thompson M, Mushti SL, Charlab R, Spehalski EI, Zhao H, Thompson MD, Tang S, Pazdur R, Lemery SJ, Theoret MR, Fashoyin-Aje LA. Kumar V, et al. Among authors: zhao h. Clin Cancer Res. 2023 Jun 1;29(11):2020-2024. doi: 10.1158/1078-0432.CCR-22-2400. Clin Cancer Res. 2023. PMID: 36485007 Free PMC article. Clinical Trial.
FDA Approval Summary: Amivantamab for the Treatment of Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Chon K, Larkins E, Chatterjee S, Mishra-Kalyani PS, Aungst S, Wearne E, Subramaniam S, Li Y, Liu J, Sun J, Charlab R, Zhao H, Saritas-Yildirim B, Bikkavilli RK, Ghosh S, Philip R, Beaver JA, Singh H. Chon K, et al. Among authors: zhao h. Clin Cancer Res. 2023 Sep 1;29(17):3262-3266. doi: 10.1158/1078-0432.CCR-22-3713. Clin Cancer Res. 2023. PMID: 37022784 Free PMC article. Clinical Trial.
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: zhao h. Clin Cancer Res. 2024 Jan 17;30(2):263-268. doi: 10.1158/1078-0432.CCR-23-1503. Clin Cancer Res. 2024. PMID: 37610803 Free PMC article. Clinical Trial.
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: zhao h. Clin Cancer Res. 2024 Jan 5;30(1):23-28. doi: 10.1158/1078-0432.CCR-23-1270. Clin Cancer Res. 2024. PMID: 37624421 Free PMC article.
US Food and Drug Administration Approval Summary: Eflornithine for High-Risk Neuroblastoma After Prior Multiagent, Multimodality Therapy.
Duke ES, Bradford D, Sinha AK, Mishra-Kalyani PS, Lerro CC, Rivera D, Wearne E, Miller CP, Leighton J, Sabit H, Zhao H, Lane A, Scepura B, Pazdur R, Singh H, Kluetz PG, Donoghue M, Drezner N. Duke ES, et al. Among authors: zhao h. J Clin Oncol. 2024 Sep 1;42(25):3047-3057. doi: 10.1200/JCO.24.00546. Epub 2024 Jun 25. J Clin Oncol. 2024. PMID: 38917371
FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma.
Brave MH, Maguire WF, Weinstock C, Zhang H, Gao X, Li F, Yu J, Fu W, Zhao H, Pierce WF, Chang E, Dinin J, Fiero MH, Rahman NA, Tang S, Pazdur R, Kluetz PG, Amiri-Kordestani L, Suzman DL. Brave MH, et al. Among authors: zhao h. Clin Cancer Res. 2024 Nov 1;30(21):4815-4821. doi: 10.1158/1078-0432.CCR-24-1393. Clin Cancer Res. 2024. PMID: 39230571 Clinical Trial.
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