Zytiga Approved for Metastatic High-Risk Castration-Sensitive Prostate Cancer

Zytiga is a CYP17 inhibitor used in the treatment of prostate cancer
Zytiga is a CYP17 inhibitor used in the treatment of prostate cancer

Janssen announced that the Food and Drug Administration (FDA) has approved Zytiga (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC).

The FDA approval was supported by results from the Phase 3 multinational, multicenter, randomized, double-blind, placebo-controlled LATITUDE trial (N=1,199) which evaluated Zytiga 1000mg once daily in combination with prednisone 5mg once daily vs placebo in newly diagnosed, metastatic high-risk CSPC patients who had not received prior cytotoxic chemotherapy. 

In the study, Zytiga plus prednisone lowered the risk of death by 38% vs placebo (median overall survival [OS] not estimable vs. 34.7 months, respectively; hazard ratio [HR] 0.62, 95% CI: 0.51, 0.76; P<0.0001). Patients in the Zytiga arm demonstrated a statistically significant delay in initiating chemotherapy vs the placebo arm (median time to initiation not reached vs 38.9 months, respectively; HR 0.44, 95% CI: 0.35, 0.56; P<0.0001).

The most common adverse reactions associated with Zytiga treatment included fatigue, arthralgia, hypotension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache. 

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Zytiga, a CYP17 inhibitor, is already indicated to treat patients with metastatic castration-resistant prostate cancer (CRPC) in combination with prednisone. It is supplied as 250mg tablets in 120-count bottles and as 500mg tablets in 60-count bottles.

For more information call (800) 526-7736 or visit Zytiga.com.