IMPACT THERAP-B (07630.HK): Sepalna Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Ovarian Cancer
- The positive opinion is mainly based on the pivotal Phase III FLAMES study, a multicentre, randomised, double-blind, placebo-controlled trial.
- In the prespecified interim analysis, median progression-free survival was not yet reached in the sepalna arm versus 13.6 months for placebo, with a hazard ratio of 0.43 (95% CI 0.32-0.58; p<0.0001), reducing the risk of disease progression or death by 57% irrespective of BRCA mutation status.
- Sepalna was approved by China's National Medical Products Administration in January 2025 for the relevant first-line maintenance treatment and included in the National Reimbursement Drug List in December 2025, with its EU marketing authorisation application accepted by the EMA in August 2025.
NewTimeSpace News: On 18 September 2026, IMPACT Therapeutics, Inc. (stock code: 07630) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorisation for Sepalna® (sepalna) for the maintenance treatment of advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. Following the CHMP's recommendation, the application will be submitted to the European Commission for a final decision, and once approved, sepalna will be authorised for marketing in all EU member states and EEA countries.
The positive opinion is mainly based on results from the pivotal Phase III FLAMES study, a multicentre, randomised, double-blind, placebo-controlled Phase III trial evaluating the efficacy and safety of sepalna versus placebo as maintenance treatment in patients with advanced (FIGO stage III-IV) epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who responded to first-line platinum-based chemotherapy. In the prespecified interim analysis, median progression-free survival was not yet reached in the sepalna arm versus 13.6 months in the placebo arm (hazard ratio = 0.43, 95% CI 0.32-0.58; p<0.0001), with sepalna reducing the risk of disease progression or death by 57%, irrespective of BRCA mutation status. Sepalna was approved by China's National Medical Products Administration in January 2025 for the relevant first-line maintenance treatment and was included in the National Reimbursement Drug List in December 2025, while its EU marketing authorisation application was accepted by the EMA in August 2025. The Company has granted Pharmanovia exclusive rights to manufacture, develop and commercialise sepalna in 66 countries, including all 27 EU member states.
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