Japan’s MHLW approves risovalisib (Risovalisib Mesilate Hydrate or Heitzexin) after chemo for ovarian clear cell carcinoma with advanced PIK3CA gene mutations
This approval is based on efficacy and safety data obtained from a single-arm, open-label, multicenter, international Phase II trial (CYH33-G201 trial). In the CYH33-G201 trial, lisovalisib 40 mg was administered orally once daily on an empty stomach to patients with PIK3CA gene mutation-positive ovarian clear cell cancer who had received prior chemotherapy. The primary endpoint, the objective response rate (ORR) based on independent imaging assessment was 34.5% (95% confidence interval: 24.28 – 45.69) in the 84 patients evaluated for efficacy.
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