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FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer.
Barbato MI, Bradford D, Ren Y, Aungst SL, Miller CP, Pan L, Zirkelbach JF, Li Y, Bi Y, Fan J, Grimstein M, Dorff SE, Amatya AK, Mishra-Kalyani PS, Scepura B, Schotland P, Udoka O, Ojofeitimi I, Leighton JK, Rahman NA, Pazdur R, Singh H, Kluetz PG, Drezner N. Barbato MI, et al. Among authors: bi y. Clin Cancer Res. 2024 Aug 15;30(16):3364-3370. doi: 10.1158/1078-0432.CCR-24-0949. Clin Cancer Res. 2024. PMID: 38875108
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
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.
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: 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
FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer.
Duke ES, Barone AK, Chatterjee S, Mishra-Kalyani PS, Shen YL, Isikwei E, Zhao H, Bi Y, Liu J, Rahman NA, Wearne E, Leighton JK, Stephenson M, Ojofeitimi I, Scepura B, Nair A, Pazdur R, Beaver JA, Singh H. Duke ES, et al. Among authors: bi y. Clin Cancer Res. 2022 Oct 3;28(19):4173-4177. doi: 10.1158/1078-0432.CCR-22-0873. Clin Cancer Res. 2022. PMID: 35679021 Free PMC article. Clinical Trial.
5,290 results