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14 results

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Page 1
FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.
Mehta GU, Vellanki PJ, Ren Y, Amatya AK, Mishra-Kalyani PS, Pan L, Zirkelbach JF, Pan Y, Liu J, Aungst SL, Miller CP, Shah M, Rahman NA, Theoret M, Kluetz P, Pazdur R, Beaver JA, Singh H. Mehta GU, et al. Among authors: zirkelbach jf. Oncologist. 2024 Aug 5;29(8):667-671. doi: 10.1093/oncolo/oyae151. Oncologist. 2024. PMID: 38970465 Free PMC article. Clinical Trial.
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: zirkelbach jf. Clin Cancer Res. 2024 Aug 15;30(16):3364-3370. doi: 10.1158/1078-0432.CCR-24-0949. Clin Cancer Res. 2024. PMID: 38875108
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: zirkelbach jf. 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.
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: zirkelbach jf. 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: 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: zirkelbach jf. 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.
FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions.
Bradford D, Larkins E, Mushti SL, Rodriguez L, Skinner AM, Helms WS, Price LSL, Zirkelbach JF, Li Y, Liu J, Charlab R, Turcu FR, Liang D, Ghosh S, Roscoe D, Philip R, Zack-Taylor A, Tang S, Kluetz PG, Beaver JA, Pazdur R, Theoret MR, Singh H. Bradford D, et al. Among authors: zirkelbach jf. Clin Cancer Res. 2021 Apr 15;27(8):2130-2135. doi: 10.1158/1078-0432.CCR-20-3558. Epub 2020 Nov 25. Clin Cancer Res. 2021. PMID: 33239432
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: zirkelbach jf. 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 Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma.
Barone A, Hazarika M, Theoret MR, Mishra-Kalyani P, Chen H, He K, Sridhara R, Subramaniam S, Pfuma E, Wang Y, Li H, Zhao H, Zirkelbach JF, Keegan P, Pazdur R. Barone A, et al. Among authors: zirkelbach jf. Clin Cancer Res. 2017 Oct 1;23(19):5661-5665. doi: 10.1158/1078-0432.CCR-16-0664. Epub 2017 Feb 8. Clin Cancer Res. 2017. PMID: 28179454 Clinical Trial.
FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P. Beaver JA, et al. Among authors: zirkelbach jf. Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31. Clin Cancer Res. 2015. PMID: 26324739 Review.
FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease.
Deisseroth A, Ko CW, Nie L, Zirkelbach JF, Zhao L, Bullock J, Mehrotra N, Del Valle P, Saber H, Sheth C, Gehrke B, Justice R, Farrell A, Pazdur R. Deisseroth A, et al. Among authors: zirkelbach jf. Clin Cancer Res. 2015 Mar 1;21(5):950-4. doi: 10.1158/1078-0432.CCR-14-1678. Epub 2015 Jan 19. Clin Cancer Res. 2015. PMID: 25601959 Review.
14 results