FDA Approves Yonsa for Metastatic Castration-Resistant Prostate Cancer
Yonsa, a CYP17 inhibitor, is a novel micronized formulation of abiraterone acetate tablets
The Food and Drug Administration (FDA) has approved Yonsa (abiraterone acetate; Sun Pharma and Churchill Pharmaceuticals) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), in combination with methylprednisolone.
Yonsa, a CYP17 inhibitor, is a novel micronized formulation of abiraterone acetate tablets. The approval of Yonsa was based on 2 randomized, placebo-controlled, multicenter Phase 3 studies in patients with mCRPC. In Study 1 (N=1195), patients with mCRPC who had received prior docetaxal chemotherapy were randomized 2:1 to receive either abiraterone acetate orally at a dose equivalent to 500mg of Yonsa once daily in combination with a different corticosteroid orally twice daily or placebo + corticosteroid. A statistically significant improvement in overall survival was seen in the primary survival analysis in patients treated with abiraterone acetate compared with placebo (median survival: 14.8 months vs 10.9 months, respectively; hazard ratio [HR] 0.646; P<.0001); results from the updated analysis were consistent with those from the interim analysis.
In Study 2, patients with mCRPC who had not received prior cytotoxic chemotherapy were randomized 1:1 to receive either abiraterone acetate at a dose equivalent to 500mg of Yonsa once daily (N=546) or placebo daily (N=542) + corticosteroid twice daily. Treatment with abiraterone acetate was associated with a statistically significant improvement in overall survival vs placebo (median survival: 34.7 months vs 30.3 months, respectively; HR 0.81; P=.0033).
Yonsa will be available in a 125mg tablet formulation. The tablets can be taken with or without food and should be swallowed whole. To avoid substitution errors and overdose, clinicians should be aware that Yonsa tablets may have different dosing and food effects than other abiraterone acetate products.
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