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U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.
Arora S, Narayan P, Osgood CL, Wedam S, Prowell TM, Gao JJ, Shah M, Krol D, Wahby S, Royce M, Ghosh S, Philip R, Ison G, Berman T, Brus C, Bloomquist EW, Fiero MH, Tang S, Pazdur R, Ibrahim A, Amiri-Kordestani L, Beaver JA. Arora S, et al. Among authors: bloomquist ew. Clin Cancer Res. 2022 Mar 15;28(6):1072-1086. doi: 10.1158/1078-0432.CCR-21-2600. Clin Cancer Res. 2022. PMID: 34711632 Free PMC article. Review.
FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.
Lee HZ, Kwitkowski VE, Del Valle PL, Ricci MS, Saber H, Habtemariam BA, Bullock J, Bloomquist E, Li Shen Y, Chen XH, Brown J, Mehrotra N, Dorff S, Charlab R, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. Lee HZ, et al. Clin Cancer Res. 2015 Jun 15;21(12):2666-70. doi: 10.1158/1078-0432.CCR-14-3119. Epub 2015 Mar 23. Clin Cancer Res. 2015. PMID: 25802282
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. 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.
U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy.
Larkins E, Scepura B, Blumenthal GM, Bloomquist E, Tang S, Biable M, Kluetz P, Keegan P, Pazdur R. Larkins E, et al. Oncologist. 2015 Nov;20(11):1320-5. doi: 10.1634/theoncologist.2015-0221. Epub 2015 Oct 7. Oncologist. 2015. PMID: 26446239 Free PMC article. Clinical Trial.
FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Walker AJ, Wedam S, Amiri-Kordestani L, Bloomquist E, Tang S, Sridhara R, Chen W, Palmby TR, Fourie Zirkelbach J, Fu W, Liu Q, Tilley A, Kim G, Kluetz PG, McKee AE, Pazdur R. Walker AJ, et al. Clin Cancer Res. 2016 Oct 15;22(20):4968-4972. doi: 10.1158/1078-0432.CCR-16-0493. Epub 2016 Jul 12. Clin Cancer Res. 2016. PMID: 27407089
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. 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
US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. Wedam SB, et al. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9. J Clin Oncol. 2018. PMID: 29522361 Free PMC article.
Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.
Howie LJ, Singh H, Bloomquist E, Wedam S, Amiri-Kordestani L, Tang S, Sridhara R, Sanchez J, Prowell TM, Kluetz PG, King-Kallimanis BL, Gao JJ, Ibrahim A, Goldberg KB, Theoret M, Pazdur R, Beaver JA. Howie LJ, et al. J Clin Oncol. 2019 Dec 20;37(36):3475-3483. doi: 10.1200/JCO.18.02217. Epub 2019 Sep 27. J Clin Oncol. 2019. PMID: 31560580
43 results