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.
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.