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Year Number of Results
2012 1
2015 1
2016 1
2017 1
2018 3
2019 2
2020 1
2021 6
2022 8
2023 7
2024 4

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29 results

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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: bi y. 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: 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: bi y. 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.
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. 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: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC.
Akinboro O, Larkins E, Pai-Scherf LH, Mathieu LN, Ren Y, Cheng J, Fiero MH, Fu W, Bi Y, Kalavar S, Jafri S, Mishra-Kalyani PS, Fourie Zirkelbach J, Li H, Zhao H, He K, Helms WS, Chuk MK, Wang M, Bulatao I, Herz J, Osborn BL, Xu Y, Liu J, Gong Y, Sickafuse S, Cohen R, Donoghue M, Pazdur R, Beaver JA, Singh H. Akinboro O, et al. Among authors: bi y. Clin Cancer Res. 2022 Jun 1;28(11):2221-2228. doi: 10.1158/1078-0432.CCR-21-3844. Clin Cancer Res. 2022. PMID: 35101885
US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer.
Akinboro O, Drezner N, Amatya A, Runyan J, Fourie-Zirkelbach J, Zhao M, Bi Y, Korsah K, Mixter B, Tang S, Larkins E, Pazdur R, Beaver JA, Singh H. Akinboro O, et al. Among authors: bi y. J Clin Oncol. 2023 Jun 10;41(17):3249-3259. doi: 10.1200/JCO.22.02509. Epub 2023 May 4. J Clin Oncol. 2023. PMID: 37141544
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: bi y. 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.
How to select the initial dose for a pediatric study?
Ye J, Bi Y, Ting N. Ye J, et al. Among authors: bi y. J Biopharm Stat. 2023 Nov 2;33(6):844-858. doi: 10.1080/10543406.2022.2149770. Epub 2022 Dec 8. J Biopharm Stat. 2023. PMID: 36476267
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: bi y. 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.
29 results