ELAHERE approved in Japan for patients with FRα-positive, platinum-resistant recurrent Ovarian cancer

CAR-T Digest - August 2020

16 September 2026: ELAHERE approved in Japan for patients with FRα-positive, platinum-resistant recurrent Ovarian cancer

Takeda announced that ELAHERE has been approved in Japan for the treatment of folate receptor alpha-positive platinum-resistant recurrent ovarian cancer, becoming the first and only ADC approved in Japan for this setting
The approval is based on results from the global phase 3 MIRASOL and SORAYA trials, supported by the Japanese phase 1/2 TAK-853-1501 study, with ELAHERE demonstrating improved PFS and OS versus investigator’s-choice chemotherapy in MIRASOL and clinically meaningful antitumor activity in FRα-positive platinum-resistant ovarian cancer
The approval addresses a major unmet need in platinum-resistant recurrent ovarian cancer, where more than 80% of patients eventually experience disease progression or recurrence and treatment options become particularly limited once tumors develop resistance to platinum-based chemotherapy
ELAHERE is an FRα-directed ADC comprising a monoclonal antibody linked to the maytansinoid DM4 payload through a cleavable linker, enabling targeted delivery of the tubulin inhibitor to FRα-expressing tumor cells following ADC internalization
Strategically, the Japan approval expands ELAHERE’s global reach to more than 50 countries and provides Takeda, which holds exclusive development and commercialization rights in Japan, with an opportunity to establish the first FRα-targeted ADC treatment in the Japanese ovarian cancer market