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Paul Kluetz

Paul G Kluetz MD

Clinical Reviewer, FDA Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration

Dr. Kluetz is a board certified medical oncologist and internist who has been a clinical reviewer at the FDA since 2010.  Dr. Kluetz attended the University of Pittsburgh School of Medicine and went on to complete internal medicine residency at the University of Maryland and his medical oncology fellowship at the National Cancer Institute (NCI) in Bethesda, MD.  At the NCI, he worked with Dr. Bill Dahut focusing on early phase clinical trials of anti-angiogenic agents in prostate cancer.

At the FDA, Dr. Kluetz has focused on genitourinary oncology drug development. He participated in the clinical review of the oral anti-cancer drug abiraterone acetate (Zytiga®) as well as the novel alpha-emitting radiopharmaceutical Radium-223 (Xofigo®), both of which were granted FDA approval to treat metastatic prostate cancer. He has represented the FDA as a speaker at several oncology drug advisory committee meetings on topics including the accelerated approval of oncology drugs and challenges involved in the development of products for non-metastatic castration resistant prostate cancer. Dr. Kluetz is engaged with the academic community both through peer-reviewed publication and as a speaker at various workshops and international meetings. He has developed a particular interest in several regulatory topics including defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval, and the opportunities and challenges associated with patient reported outcomes data.

Dr. Kluetz remains clinically active, treating prostate cancer patients at the National Institutes of Health and practicing inpatient medicine at Georgetown University Hospital.

Recent Contributions to PracticeUpdate:

  1. FDA Approval of Oncology Products