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FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.
Nakajima EC, Drezner N, Li X, Mishra-Kalyani PS, Liu Y, Zhao H, Bi Y, Liu J, Rahman A, Wearne E, Ojofeitimi I, Hotaki LT, Spillman D, Pazdur R, Beaver JA, Singh H. Nakajima EC, et al. Among authors: hotaki lt. Clin Cancer Res. 2022 Apr 14;28(8):1482-1486. doi: 10.1158/1078-0432.CCR-21-3074. Clin Cancer Res. 2022. PMID: 34903582 Free PMC article.
FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma.
Nakajima EC, Vellanki PJ, Larkins E, Chatterjee S, Mishra-Kalyani PS, Bi Y, Qosa H, Liu J, Zhao H, Biable M, Hotaki LT, Shen YL, Pazdur R, Beaver JA, Singh H, Donoghue M. Nakajima EC, et al. Among authors: hotaki lt. Clin Cancer Res. 2022 Feb 1;28(3):446-451. doi: 10.1158/1078-0432.CCR-21-1466. Epub 2021 Aug 30. Clin Cancer Res. 2022. PMID: 34462287 Free PMC article.
Project Orbis: Global Collaborative Review Program.
de Claro RA, Spillman D, Hotaki LT, Shum M, Mouawad LS, Santos GML, Robinson K, Hunt M, Healy C, Chan A, Looi YH, Rodrigues C, Rohr UP, Walther C, Pazdur R. de Claro RA, et al. Among authors: hotaki lt. Clin Cancer Res. 2020 Dec 15;26(24):6412-6416. doi: 10.1158/1078-0432.CCR-20-3292. Epub 2020 Oct 9. Clin Cancer Res. 2020. PMID: 33037016
Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.
Hotaki LT, Shrestha A, Bennett MP, Valdes IL, Lee SH, Wang Y, Spillman D, MacAulay T, Hunt M, Gervais J, Mafi M, Panetta V, Looi YH, Shum M, Atiek E, Meincke R, Rohr UP, Ainbinder D, Boehm-Cagan A, Luxenburg O, Cerqueira MR, Mouawad LS, Thees MFRES, Prasad K, de Claro RA. Hotaki LT, et al. Ther Innov Regul Sci. 2023 Jul;57(4):875-885. doi: 10.1007/s43441-023-00522-4. Epub 2023 Apr 18. Ther Innov Regul Sci. 2023. PMID: 37072651 Review.