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Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies.
Brewer JR, Chang E, Agrawal S, Singh H, Suzman DL, Xu J, Weinstock C, Fernandes LL, Cheng J, Zhang L, Xie D, Goldberg KB, Bloomquist EW, Tang S, Sridhara R, Theoret MR, Pazdur R, Ibrahim A, Beaver JA. Brewer JR, et al. Among authors: theoret mr. Clin Cancer Res. 2020 Dec 15;26(24):6406-6411. doi: 10.1158/1078-0432.CCR-19-4229. Epub 2020 Jul 30. Clin Cancer Res. 2020. PMID: 32732222
FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.
Kim G, McKee AE, Ning YM, Hazarika M, Theoret M, Johnson JR, Xu QC, Tang S, Sridhara R, Jiang X, He K, Roscoe D, McGuinn WD, Helms WS, Russell AM, Miksinski SP, Zirkelbach JF, Earp J, Liu Q, Ibrahim A, Justice R, Pazdur R. Kim G, et al. Clin Cancer Res. 2014 Oct 1;20(19):4994-5000. doi: 10.1158/1078-0432.CCR-14-0776. Epub 2014 Aug 5. Clin Cancer Res. 2014. PMID: 25096067 Review.
Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.
Theoret MR, Pai-Scherf LH, Chuk MK, Prowell TM, Balasubramaniam S, Kim T, Kim G, Kluetz PG, Keegan P, Pazdur R. Theoret MR, et al. Clin Cancer Res. 2015 Oct 15;21(20):4545-51. doi: 10.1158/1078-0432.CCR-14-3244. Clin Cancer Res. 2015. PMID: 26473190
Seamless Oncology-Drug Development.
Prowell TM, Theoret MR, Pazdur R. Prowell TM, et al. Among authors: theoret mr. N Engl J Med. 2016 May 26;374(21):2001-3. doi: 10.1056/NEJMp1603747. Epub 2016 Apr 13. N Engl J Med. 2016. PMID: 27074059 No abstract available.
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab.
Hazarika M, Chuk MK, Theoret MR, Mushti S, He K, Weis SL, Putman AH, Helms WS, Cao X, Li H, Zhao H, Zhao L, Welch J, Graham L, Libeg M, Sridhara R, Keegan P, Pazdur R. Hazarika M, et al. Among authors: theoret mr. Clin Cancer Res. 2017 Jul 15;23(14):3484-3488. doi: 10.1158/1078-0432.CCR-16-0712. Epub 2017 Jan 13. Clin Cancer Res. 2017. PMID: 28087644 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: theoret mr. 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 Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.
Chuk MK, Chang JT, Theoret MR, Sampene E, He K, Weis SL, Helms WS, Jin R, Li H, Yu J, Zhao H, Zhao L, Paciga M, Schmiel D, Rawat R, Keegan P, Pazdur R. Chuk MK, et al. Among authors: theoret mr. Clin Cancer Res. 2017 Oct 1;23(19):5666-5670. doi: 10.1158/1078-0432.CCR-16-0663. Epub 2017 Feb 24. Clin Cancer Res. 2017. PMID: 28235882 Clinical Trial.
118 results