Zytiga (Abiraterone) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer

On February 8th, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Zytiga® (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk hormone-sensitive prostate cancer (HSPC). The approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk HSPC, Zytiga® in combination with prednisone reduced the risk of death by 38% compared to placebos.

This approval marks an important step in addressing the unmet needs of patients with metastatic high-risk hormone-sensitive prostate cancer by providing an option that has demonstrated improvement in overall survival.  Zytiga® (abiraterone acetate) plus prednisone could become a standard of care for these patients.

LATITUDE was a multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial that examined the use of Zytiga® 1,000 mg once daily in combination with prednisone 5 mg once daily, compared to placebos in patients with newly diagnosed, metastatic high-risk HSPC, who had not received prior cytotoxic chemotherapy. All the patients received a gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy. The study data were presented at the plenary session of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, and simultaneously published in The New England Journal of Medicine. The study showed Zytiga® in combination with prednisone reduced the risk of death by 38% compared to placebos. Additional data demonstrated statistically significant delay in time to initiation of chemotherapy for patients in the Zytiga® arm compared to those in the placebo arm.

The Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled LATITUDE study enrolled 1,199 patients with newly diagnosed metastatic, high-risk hormone-sensitive prostate cancer (HSPC), who had not received prior cytotoxic chemotherapy. The study was conducted at 235 sites in 34 countries in Europe, Asia-Pacific, Latin America, and Canada. A total number of 597 patients were randomized to receive Zytiga® plus prednisone, while 602 patients were randomized to receive placebo. All patients received a gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy. High-risk disease was defined as having at least two of three risk factors at baseline: a total Gleason score of ≥8, presence of ≥3 lesions on bone scan, and evidence of measurable visceral metastases. Patients with significant cardiac, adrenal, or hepatic dysfunction were excluded. The median duration of treatment with Zytiga® and prednisone was 24 months.

Zytiga® (abiraterone acetate) in combination with prednisone is now indicated for the treatment of patients with metastatic hormone-resistant prostate cancer (HRPC) and with metastatic high-risk hormone-sensitive prostate cancer (HSPC). For additional details, see the following link.

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