FDA Expands Approval of Combination Therapy for Castration-Sensitive Prostate Cancer

02/09/18

The US Food and Drug Administration (FDA) has approved a hormone-based chemotherapy in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer.

Abiraterone acetate (Zytiga, Janssen Biotech Inc) was originally granted approval with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer who had received prior chemotherapy. Expanded approval came in 2012 for patients with metastatic castration-resistant prostate cancer.

The recent FDA approval came following data from a recent trial (LATITUDE). A total of 1199 patients with metastatic high-risk castration-sensitive prostate cancer were randomized to receive either abiraterone acetate (1000 mg orally, once daily) with prednisone (5 mg, once daily) or placebos (orally, once daily). Patients in both arms received a gonadotropin releasing hormone or had a bilateral orchiectomy.

Results of the study showed that median overall survival was not reached and 34.7 months in the abiraterone acetate and placebo arms, respectively (HR, 0.62; 95% CI, 0.51-0.75; P < .0001).

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Common adverse events associated with abiraterone acetate include hypertension, hot flash, hypokalemia, increased alanine aminotransferase or aspartate aminotransferase, headache, urinary tract infection, upper respiratory tract infection, and cough.—Zachary Bessette