Takeda Wins Japan Approval for Elahere in Ovarian Cancer
核心洞察
Takeda received Japanese marketing approval on September 16 for Elahere, an antibody-drug conjugate targeting folate receptor alpha (搜索), in platinum-resistant recurrent ovarian cancer (搜索).
Elahere, or mirvetuximab soravtansine, is the first and only antibody-drug conjugate approved in Japan for this folate receptor alpha (搜索)-positive indication.
The approval rests on the Phase 3 MIRASOL and SORAYA trials plus the domestic Phase 1/2 TAK-853-1501 study, with MIRASOL showing progression-free and overall survival benefit.
Takeda Pharmaceutical said on September 16 that Japan's Ministry of Health, Labour and Welfare had granted marketing approval for Elahere (mirvetuximab soravtansine) Intravenous Infusion 100 mg. The antibody-drug conjugate binds folate receptor alpha (搜索) and is indicated for folate receptor alpha-positive recurrent ovarian cancer (搜索) resistant to platinum-based antineoplastic agents. According to the release, it is the first and only antibody-drug conjugate approved in Japan for that indication, and Takeda holds exclusive development and commercialization rights in the country.
The approval was based on the overseas Phase 3 MIRASOL and SORAYA trials and the domestic Phase 1/2 TAK-853-1501 study in the same platinum-resistant population. MIRASOL, which enrolled patients with one to three prior lines of chemotherapy, compared mirvetuximab soravtansine with investigator's choice of single-agent chemotherapy including paclitaxel, pegylated liposomal doxorubicin or topotecan, and showed benefit on progression-free survival, the primary endpoint, and overall survival. Ocular, gastrointestinal and peripheral neuropathy adverse events in the mirvetuximab soravtansine arm were mainly low grade, and discontinuation due to adverse events was 9% versus 16% with chemotherapy. MIRASOL data were published in The New England Journal of Medicine in December 2023.
Takeda said the Phase 2 portion of TAK-853-1501, conducted in Japanese patients to assess safety, efficacy and pharmacokinetics, showed profiles consistent with MIRASOL and SORAYA. Elahere pairs a monoclonal antibody targeting folate receptor alpha (搜索) with the maytansinoid payload DM4 (搜索); folate receptor alpha is expressed in about 90% of ovarian cancer (搜索) cases. As of September 2026 the drug had been approved in more than 50 countries or regions, including the United States and the European Union. In Japan, 12,926 ovarian cancer cases were diagnosed in 2023, and more than 80% of patients progress or recur despite high initial response rates, with platinum-resistant recurrence defined as recurrence within six months of the last platinum dose.