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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: amatya ak. 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.
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
Amatya AK, Fiero MH, Bloomquist EW, Sinha AK, Lemery SJ, Singh H, Ibrahim A, Donoghue M, Fashoyin-Aje LA, de Claro RA, Gormley NJ, Amiri-Kordestani L, Sridhara R, Theoret MR, Kluetz PG, Pazdur R, Beaver JA, Tang S. Amatya AK, et al. Clin Cancer Res. 2021 Nov 1;27(21):5753-5756. doi: 10.1158/1078-0432.CCR-20-4912. Epub 2021 Jun 11. Clin Cancer Res. 2021. PMID: 34117032 Free PMC article. Review.
Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer.
Mason J, Gong Y, Amiri-Kordestani L, Wedam S, Gao JJ, Prowell TM, Singh H, Amatya A, Tang S, Pazdur R, Kuhn P, Blumenthal GM, Beaver JA. Mason J, et al. JCO Clin Cancer Inform. 2021 Jun;5:758-767. doi: 10.1200/CCI.21.00025. JCO Clin Cancer Inform. 2021. PMID: 34297598 Free PMC article.
Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials.
Fallah J, Zhang L, Amatya A, Gong Y, King-Kallimanis B, Bhatnagar V, Weinstock C, Suzman DL, Agrawal S, Chang E, Anscher MS, Chi DC, Xu JX, Brewer JR, Brave MH, Hadadi M, Theoret MR, Kluetz PG, Goldberg KB, Ibrahim A, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L, Singh H. Fallah J, et al. Lancet Oncol. 2021 Sep;22(9):1230-1239. doi: 10.1016/S1470-2045(21)00334-X. Epub 2021 Jul 23. Lancet Oncol. 2021. PMID: 34310904
FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.
Royce M, Osgood CL, Amatya AK, Fiero MH, Chang CJG, Ricks TK, Shetty KA, Kraft J, Qiu J, Song P, Charlab R, Yu J, King KE, Rastogi A, Janelsins B, Weinberg WC, Clouse K, Borders-Hemphill V, Brown L, Gomez-Broughton C, Li Z, Nguyen TT, Qiu Z, Ly AT, Chang S, Gao T, Tu CM, King-Kallimanis B, Pierce WF, Chiang K, Lee C, Goldberg KB, Leighton JK, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. Royce M, et al. Among authors: amatya ak. Clin Cancer Res. 2022 Apr 14;28(8):1487-1492. doi: 10.1158/1078-0432.CCR-21-3247. Clin Cancer Res. 2022. PMID: 34916216 Free PMC article. Clinical Trial.
Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy: A Pooled Analysis of Trials in the US Food and Drug Administration Database.
Anscher MS, Arora S, Weinstock C, Amatya A, Bandaru P, Tang C, Girvin AT, Fiero MH, Tang S, Lubitz R, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA. Anscher MS, et al. JAMA Oncol. 2022 Feb 1;8(2):232-240. doi: 10.1001/jamaoncol.2021.6439. JAMA Oncol. 2022. PMID: 34989781 Free PMC article.
FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer.
Shah M, Osgood CL, Amatya AK, Fiero MH, Pierce WF, Nair A, Herz J, Robertson KJ, Mixter BD, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. Shah M, et al. Among authors: amatya ak. Clin Cancer Res. 2022 Dec 15;28(24):5249-5253. doi: 10.1158/1078-0432.CCR-22-1110. Clin Cancer Res. 2022. PMID: 35925043 Clinical Trial.
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: amatya ak. 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.
[No title available]
[No authors listed] [No authors listed] PMID: 37219515
40 results