FDA Approves Castration-Sensitive Prostate Cancer Drug

Officials with the FDA have granted approval to abiraterone acetate (Zytiga) tablets in combination with prednisone for the treatment of metastatic high-risk castration-sensitive prostate cancer (CSPC), according to a press release.

Abiraterone acetate previously gained FDA approval in 2011 for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who had previously received chemotherapy. Additionally, the drug is indicated to treat patients with CRPC.

The new approval in CSPC was granted based on positive findings from the LATITUTDE clinical trial, which included 1199 patients with CSPC. Patients were randomized to receive abiraterone acetate 1000-mg plus prednisone 5-mg once daily or placebo. The FDA noted that patients in both cohorts were treated with gonadotropin-releasing hormone therapy or had a bilateral orchiectomy, according to the release.

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