Cancer News

FDA Approves Xtandi for Treatment of Castration-resistant Prostate Cancer

On July 13, 2018, the Food and Drug Administration approved Xtandi (enzalutamide) for patients with castration-resistant prostate cancer (CRPC).  This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Xtandi was previously approved for the treatment of patients with metastatic CRPC.

About Prostate Cancer

Prostate cancer is the second most common cancer in men worldwide.1 More than 164,000 men in the United States are estimated to be newly diagnosed with prostate cancer in 2018.2  Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses despite castrate levels of testosterone (i.e., less than 50 ng/dL).3 Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body (metastases), and there is a rising prostate-specific antigen (PSA) level.4 Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.

About XTANDI® (enzalutamide) capsules

Xtandi is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer.

The FDA approval of Xtandi in patients with NM-CRPC was based on a randomized, multicenter clinical trial (PROSPER, NCT020032924), that directly compared, 1401 patients treated with Xtandi and androgen deprivation therapy (ADT) with either a bilateral orchiectomy, or gonadotropin-releasing hormone (GnRH) therapy to ADT alone.

The clinical trial demonstrated a significant improvement in survival without progression of metastases of 36.6 months for patients receiving Xtandi compared to only 14.7 months for individuals treated with ADT alone.  The results of this trial which were first presented publicly in February at the 2018 ASCO Genitourinary Cancers Symposium, and was published in the New England Journal of Medicine by Dr. Hussain at the Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University. 5

In February 2018, the FDA also approved Erleada for treatment of NM-CRPC.  Prior to this year, there were no FDA-approved treatments for NM- CRPC, and these patients typically continued to receive ADT alone, despite a diminishing benefit.  Today, men with NM-CRPC have two treatment choices, both of which significantly delay metastatic disease.6


  2. American Cancer Society. Cancer Facts & Figures 2018.….
  3. Urology Care Foundation. Advanced Prostate Cancer Patient Guide. org/educational-materials.
  4. Luo J, Beer T, Graff J. Treatment of Non-metastatic Castration Resistant Prostate Cancer. Oncology. April 2016, 30(4):336-344.

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