FDA OKs Enzalutamide for Non-Metastatic Castration-Resistant Prostate Cancer

Enzalutamide (Xtandi) is the first and only FDA-approved oral medication for both non-metastatic and metastatic castration-resistant prostate cancer.

The FDA has approved the supplemental New Drug Application (sNDA) for enzalutamide (Xtandi) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), according to a press release.

With this new indication, enzalutamide is the first and only FDA-approved oral medication for both non-metastatic and metastatic CRPC.

The latest approval for enzalutamide, which was previously granted FDA Priority Review designation for this indication, is based on data from the phase 3 PROSPER trial. Enzalutamide was initially approved in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel and was granted another approval in 2014 for chemotherapy-naïve men with metastatic CRPC.

The trial, which enrolled 1401 patients with non-metastatic CRPC, investigated the use of enzalutamide plus androgen deprivation therapy (ADT) compared with ADT alone in men with non-metastatic CRPC.

According to the data, enzalutamide plus ADT significantly reduced the risk of developing metastasis or death compared with ADT alone. For men who received the combination, the primary endpoint, metastasis-free survival (MFS), was 36.6 months compared with 14.7 months in the other group.

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The results build on the body of evidence for the use of enzalutamide in prostate cancer, according to a press release.

“Reducing the risk of disease progression is an important treatment goal in castration-resistant prostate cancer, since the disease becomes harder to treat as it advances,” Andy Schmeltz, global president, Oncology Pfizer, said in the press release. “With Xtandi, men with CRPC now have a clinically proven treatment option that reduces the risk of metastasis. This approval delivers on the potential for Xtandi to help men at an earlier stage of the disease, and we are continuing to evaluate the medicine in an extensive development program across additional prostate cancer populations.”

The most common adverse effects associated with the treatment included asthenic conditions, hot flush, hypertension, dizziness, nausea, and fall.

Reference

US FDA Approves Xtandi (Enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) [news release]. Pfizer’s website. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_xtandi_enzalutamide_for_the_treatment_of_men_with_non_metastatic_castration_resistant_prostate_cancer_crpc. Accessed July 16, 2018.