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Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration-Melanoma Research Alliance Public Workshop.
Mueller KL, Theoret MR, Lemery SJ, Amiri-Kordestani L, Ariyan CE, Atkins MB, Berry DA, Blank CU, DeMichele AM, Forde PM, Ibrahim N, Keegan P, Mitchell TC, Moss RA, Robert C, Sridhara R, Taube JM, Tetzlaff MT, Wargo JA, Flaherty KT, Kaplan MJ, Topalian SL, Ward AF, Hurlbert MS. Mueller KL, et al. Among authors: keegan p. Clin Cancer Res. 2021 Jan 15;27(2):394-401. doi: 10.1158/1078-0432.CCR-20-3285. Epub 2020 Nov 13. Clin Cancer Res. 2021. PMID: 33188142 Review.
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, Keegan P, Pazdur R. Lemery SJ, et al. Among authors: keegan p. Clin Cancer Res. 2010 Sep 1;16(17):4331-8. doi: 10.1158/1078-0432.CCR-10-0570. Epub 2010 Jul 2. Clin Cancer Res. 2010. PMID: 20601446
Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a "physician's choice" control arm in a randomized approval trial.
Donoghue M, Lemery SJ, Yuan W, He K, Sridhara R, Shord S, Zhao H, Marathe A, Kotch L, Jee J, Wang Y, Zhou L, Adams WM, Jarral V, Pilaro A, Lostritto R, Gootenberg JE, Keegan P, Pazdur R. Donoghue M, et al. Among authors: keegan p. Clin Cancer Res. 2012 Mar 15;18(6):1496-505. doi: 10.1158/1078-0432.CCR-11-2149. Epub 2012 Jan 26. Clin Cancer Res. 2012. PMID: 22282463
US Food and Drug Administration approval overview in metastatic breast cancer.
Cortazar P, Justice R, Johnson J, Sridhara R, Keegan P, Pazdur R. Cortazar P, et al. Among authors: keegan p. J Clin Oncol. 2012 May 10;30(14):1705-11. doi: 10.1200/JCO.2011.39.2613. Epub 2012 Mar 19. J Clin Oncol. 2012. PMID: 22430273 Free PMC article. Review. No abstract available.
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. Among authors: keegan p. Clin Cancer Res. 2015 Oct 15;21(20):4545-51. doi: 10.1158/1078-0432.CCR-14-3244. Clin Cancer Res. 2015. PMID: 26473190
FDA's Approach to Regulating Biosimilars.
Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R. Lemery SJ, et al. Among authors: keegan p. Clin Cancer Res. 2017 Apr 15;23(8):1882-1885. doi: 10.1158/1078-0432.CCR-16-1354. Epub 2016 Dec 29. Clin Cancer Res. 2017. PMID: 28034906
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: keegan p. 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: keegan p. 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.
182 results