W. Pierce

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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: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer

K. Goldberg, R. Pazdur, L. Amiri-Kordestani, 2020, Clinical Cancer Research.

FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

G. Demetri, L. Burke, Martha Donoghue, 2020, Clinical Cancer Research.

Patient-reported outcomes supporting anticancer product approvals.

L. Burke, E. Rock, D. Kennedy, 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Essential Medications for Patients With Suspected or Confirmed Ebola Virus Disease in Resource-Limited Environments.

R. Childs, W. Pierce, Selena D Ready, 2017, Military medicine.

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.

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.

Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary

P. Stephens, R. Pazdur, A. Al-Hakim, 2013, Clinical Cancer Research.

Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Previously Received Docetaxel: U.S. Food and Drug Administration Drug Approval Summary

Dhananjay D. Marathe, R. Pazdur, Todd R. Palmby, 2013, Clinical Cancer Research.

FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs

Sarah E. Dorff, Amy McKee, R. Pazdur, 2016, Clinical Cancer Research.

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

K. Goldberg, R. Pazdur, P. Zhao, 2018, Clinical Cancer Research.

FDA Approval Summary: Belzutifan for von Hippel-Lindau disease associated tumors.

Sarah E. Dorff, Martha Donoghue, R. Pazdur, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma

L. Fashoyin-Aje, K. Goldberg, R. Pazdur, 2021, Clinical Cancer Research.

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Jiang Liu, L. Fashoyin-Aje, Martha Donoghue, 2020, Clinical Cancer Research.

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation–Associated Advanced Ovarian Cancer

S. J. Schrieber, Chao Liu, Richard Pazdur, 2017, Clinical Cancer Research.

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

R. Pazdur, Todd R. Palmby, L. Amiri-Kordestani, 2018, Clinical Cancer Research.

The Combination of Exposure‐Response and Case‐Control Analyses in Regulatory Decision Making

C. Garnett, P. Keegan, J. Gobburu, 2013, Journal of clinical pharmacology.

Combination of exposure-response and case-control analyses in regulatory decision making.

C Garnett, J Gobburu, C. Garnett, 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy

Anuradha Ramamoorthy, Richard Pazdur, Kaushalkumar Dave, 2018, Clinical Cancer Research.

FDA Approval Summary: lutetium Lu 177 vipivotide tetraxetan for patients with metastatic castration-resistant prostate cancer.

A. Fotenos, R. Pazdur, H. Gittleman, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval Summary: Belzutifan for VHL Disease Tumors-Response.

R. Pazdur, L. Amiri-Kordestani, D. Suzman, 2023, Clinical cancer research : an official journal of the American Association for 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.

FDA Approval Summary: Ivosidenib for the treatment of patients with advanced unresectable or metastatic, chemotherapy refractory cholangiocarcinoma with an IDH1 mutation.

Jiang Liu, L. Fashoyin-Aje, R. Pazdur, 2022, 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: Mirvetuximab soravtansine-gynx for FRα-positive, Platinum-Resistant Ovarian Cancer.

R. Pazdur, R. Pragani, H. Gittleman, 2023, Clinical cancer research : an official journal of the American Association for Cancer Research.

Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Previously Received Docetaxel: U.S. Food and Drug Administration Drug Approval Summary

Dhananjay D. Marathe, R. Pazdur, Todd R. Palmby, 2013, Clinical Cancer Research.

FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs

Amy McKee, R. Pazdur, R. Charlab, 2016, Clinical 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.