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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: spillman d. 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: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis.
Arora S, Balasubramaniam S, Zhang W, Zhang L, Sridhara R, Spillman D, Mathai JP, Scott B, Golding SJ, Coory M, Pazdur R, Beaver JA. Arora S, et al. Among authors: spillman d. Clin Cancer Res. 2020 Oct 1;26(19):5062-5067. doi: 10.1158/1078-0432.CCR-19-3979. Epub 2020 Apr 15. Clin Cancer Res. 2020. PMID: 32295834 Review.
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: spillman d. 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
FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review.
Vellanki PJ, Mulkey F, Jaigirdar AA, Rodriguez L, Wang Y, Xu Y, Zhao H, Liu J, Howe G, Wang J, Choo Q, Golding SJ, Mansell V, Korsah K, Spillman D, de Claro RA, Pazdur R, Beaver JA, Singh H. Vellanki PJ, et al. Among authors: spillman d. Clin Cancer Res. 2021 Jul 1;27(13):3522-3527. doi: 10.1158/1078-0432.CCR-20-4338. Epub 2021 Feb 25. Clin Cancer Res. 2021. PMID: 33632925 Free PMC article. Clinical Trial.
FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review.
Koch AL, Vellanki PJ, Drezner N, Li X, Mishra-Kalyani PS, Shen YL, Xia H, Li Y, Liu J, Zirkelbach JF, Palazov E, Gamarian A, Choo Q, Girčys A, Rohr UP, Fesenko N, Spillman D, Pazdur R, Beaver JA, Singh H. Koch AL, et al. Among authors: spillman d. Clin Cancer Res. 2021 Dec 15;27(24):6638-6643. doi: 10.1158/1078-0432.CCR-21-1034. Epub 2021 Jul 22. Clin Cancer Res. 2021. PMID: 34301748 Clinical Trial.
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. Among authors: spillman d. 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.
In Vivo Optical Characterization of Middle Ear Effusions and Biofilms During Otitis Media.
Won J, Monroy GL, Khampang P, Barkalifa R, Hong W, Chaney EJ, Aksamitiene E, Porter RG, Novak MA, Spillman DR Jr, Kerschner JE, Boppart SA. Won J, et al. Among authors: spillman dr jr. J Assoc Res Otolaryngol. 2023 Jun;24(3):325-337. doi: 10.1007/s10162-023-00901-6. Epub 2023 May 30. J Assoc Res Otolaryngol. 2023. PMID: 37253962
64 results