On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.
The sponsor for Erleada is the first participant in the FDA’s recently-announced Clinical Data Summary Pilot Program, an effort to provide stakeholders with more usable information on the clinical evidence supporting drug product approvals and more transparency into the FDA’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page.
Read FDA press release.
Posted 2/14/2018
At the 2026 ASCO Annual Meeting, the Louisiana Oncology Society received the ASCO Jeffrey C Ward Affiliate Advocacy Award for advancing critical advocacy priorities that have translated into meaningful legislative victories. The Iowa Oncology Society and Washington State Medical Oncology Society were also recognized for their advocacy efforts in 2025 at the meeting, receiving second place awards.
