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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: bi 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.
Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib.
Pelosof L, Lemery S, Casak S, Jiang X, Rodriguez L, Pierre V, Bi Y, Liu J, Zirkelbach JF, Patel A, Goldberg KB, McKee AE, Keegan P, Pazdur R. Pelosof L, et al. Among authors: bi y. Oncologist. 2018 Apr;23(4):496-500. doi: 10.1634/theoncologist.2017-0422. Epub 2018 Jan 31. Oncologist. 2018. PMID: 29386313 Free PMC article. Clinical Trial.
FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.
Shah A, Bloomquist E, Tang S, Fu W, Bi Y, Liu Q, Yu J, Zhao P, Palmby TR, Goldberg KB, Chang CJG, Patel P, Alebachew E, Tilley A, Pierce WF, Ibrahim A, Blumenthal GM, Sridhara R, Beaver JA, Pazdur R. Shah A, et al. Among authors: bi y. Clin Cancer Res. 2018 Jul 1;24(13):2999-3004. doi: 10.1158/1078-0432.CCR-17-2369. Epub 2018 Feb 7. Clin Cancer Res. 2018. PMID: 29437768
FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions.
Kim J, Bradford D, Larkins E, Pai-Scherf LH, Chatterjee S, Mishra-Kalyani PS, Wearne E, Helms WS, Ayyoub A, Bi Y, Sun J, Charlab R, Liu J, Zhao H, Liang D, Ghosh S, Philip R, Pazdur R, Theoret MR, Beaver JA, Singh H. Kim J, et al. Among authors: bi y. Clin Cancer Res. 2021 Oct 15;27(20):5452-5456. doi: 10.1158/1078-0432.CCR-21-0967. Epub 2021 May 27. Clin Cancer Res. 2021. PMID: 34045295
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: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations.
Mathieu LN, Larkins E, Akinboro O, Roy P, Amatya AK, Fiero MH, Mishra-Kalyani PS, Helms WS, Myers CE, Skinner AM, Aungst S, Jin R, Zhao H, Xia H, Zirkelbach JF, Bi Y, Li Y, Liu J, Grimstein M, Zhang X, Woods S, Reece K, Abukhdeir AM, Ghosh S, Philip R, Tang S, Goldberg KB, Pazdur R, Beaver JA, Singh H. Mathieu LN, et al. Among authors: bi y. Clin Cancer Res. 2022 Jan 15;28(2):249-254. doi: 10.1158/1078-0432.CCR-21-1566. Epub 2021 Aug 3. Clin Cancer Res. 2022. PMID: 34344795 Review.
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: bi y. 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.
5,296 results