Editor’s Note: FDA Response to Comments by Dr. Steven E. Vogl

Get Permission

In 2011, the U.S. Food and Drug Administration (FDA) convened an advisory committee that recognized metastasis-free survival as a clinically relevant endpoint for nonmetastatic prostate cancer due to shorter trial readout times and acknowledgment that a substantial delay in the transition to a metastatic state was in and of itself a clinical benefit. After careful consideration, the FDA did not restrict the indication of apalutamide (Erleada) to prostate-specific antigen (PSA) doubling times of up to 10 months due to the consistent efficacy across quartiles of PSA doubling times, large magnitude of metastasis-free survival benefit, acceptable safety profile (despite longer median exposure), and no overall survival detriment. Rather, the indication leaves PSA cutoff to the physician’s discretion, with product labeling describing the SPARTAN trial population. Final overall survival data submission is a postmarketing commitment. The FDA’s review of the application can be found at Drugs@FDA. ■

Julia Beaver, MD; Chana Weinstock, MD; Daniel Suzman, MD;
and Dow-Chung Chi, MD; Gideon M. Blumenthal, MD

Office of Hematology and Oncology Products
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, Maryland

DISCLOSURE: Drs. Beaver, Weinstock, Suzman, Chi, and Blumenthal reported no conflicts of interest.

Related Articles

Should We Treat Rising PSA in Men With Castrate Androgen Levels?

At Microphone 1  is an occasional column written by Steven E. Vogl, MD, of the Bronx, New York. When he is not in his clinic, Dr. Vogl can generally be found at major oncology meetings and often at the microphone, where he stands ready with critical questions for presenters of new data.