C. Osgood

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FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer

K. Goldberg, R. Pazdur, L. Amiri-Kordestani, 2021, Clinical Cancer Research.

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2022, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Bringing Safe and Effective Therapies to Premenopausal Women with Breast Cancer: Efforts to Broaden Eligibility Criteria.

F. Cardoso, M. Goetz, M. Regan, 2021, Annals of oncology : official journal of the European Society for Medical Oncology.

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2020, Clinical Cancer Research.

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective.

P. Keegan, B. Booth, B. Furmanski, 2019, Annals of Oncology.

Clostridium difficile infection in the pediatric transplant patient

K. Edwards, M. Nicholson, S. Acra, 2015, Pediatric transplantation.

Postmarketing Colitis Cases Associated With Alpelisib Use Reported to the US Food and Drug Administration.

Tatiana M. Prowell, G. Dores, Kathleen M Sullivan, 2022, JAMA Oncology.

Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.

R. Pazdur, L. Amiri-Kordestani, Tatiana M. Prowell, 2021, The Lancet. Oncology.

Overall Survival in Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Treated with a CDK 4/6 Inhibitor Plus Fulvestrant: A U.S. Food and Drug Administration Pooled Analysis

R. Pazdur, L. Amiri-Kordestani, Tatiana M. Prowell, 2021, SSRN Electronic Journal.

U.S. FDA Drug Approvals for Breast Cancer - A Decade in Review.

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2021, Clinical cancer research : an official journal of the American Association for Cancer Research.

Identi fi cation of Mithramycin Analogues with Improved Targeting of the EWS-FLI 1 Transcription Factor

L. Turner, S. Lessnick, L. Helman, 2016 .

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer

Sarah E. Dorff, L. Fashoyin-Aje, K. Goldberg, 2020, Clinical Cancer Research.

FDA analysis of depth of response (DpR) and survival across 10 randomized controlled trials in patients with previously untreated unresectable or metastatic melanoma (UMM) by therapy type.

P. Keegan, R. Pazdur, R. Sridhara, 2019, Journal of Clinical Oncology.

FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen

Lan Huang, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective.

P. Keegan, B. Booth, B. Furmanski, 2019, Annals of oncology : official journal of the European Society for Medical Oncology.

Identification of Mithramycin Analogues with Improved Targeting of the EWS-FLI1 Transcription Factor

L. Turner, S. Lessnick, L. Helman, 2016, Clinical Cancer Research.

US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer

R. Pazdur, L. Amiri-Kordestani, M. Kondratovich, 2023, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

18F-FLT Positron Emission Tomography (PET) is a Pharmacodynamic Marker for EWS-FLI1 Activity and Ewing Sarcoma

P. Grohar, H. Manning, E. Boguslawski, 2016, Scientific Reports.

U.S. FDA Drug Approvals for Gynecological Malignancies - A Decade in Review.

Reena Philip, R. Pazdur, L. Amiri-Kordestani, 2021, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple Negative Breast Cancer.

R. Pazdur, L. Amiri-Kordestani, Shenghui Tang, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval Summary: Margetuximab plus chemotherapy for advanced or metastatic HER2-positive breast cancer.

R. Pazdur, R. Charlab, B. King-Kallimanis, 2021, Clinical cancer research : an official journal of the American Association for Cancer Research.