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Publications by Amy E. McKee

U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma

Clinical Cancer Research
Cancer ResearchOncology
2016English

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Clinical Cancer Research
Cancer ResearchOncology
2016English

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma

Clinical Cancer Research
Cancer ResearchOncology
2018English

NCCN Working Group Report: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies

Journal of the National Comprehensive Cancer Network : JNCCN
MedicineOncology
2014English

Regulatory Considerations on Endpoints in Ovarian Cancer Drug Development

Cancer
Cancer ResearchOncology
2017English

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

Oncologist
Cancer ResearchMedicineOncology
2017English

How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?

Journal of Clinical Pharmacology
Pharmacology
2017English

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