Takeda submits new drug application for Mirvetuximab Soravtansine for folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer in Japan

CAR-T Digest - August 2020

Weekly Digest - February 2026

30 January 2026: Takeda submits new drug application for Mirvetuximab Soravtansine for folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer in Japan

Takeda has moved a step closer to expanding treatment options for a difficult-to-treat ovarian cancer population, submitting a New Drug Application in Japan for Mirvetuximab soravtansine in patients with folate receptor alpha (FRα)-positive, platinum-resistant recurrent ovarian cancer, an area where prognosis remains poor and therapeutic choices are limited
This regulatory filing is based on robust clinical data, bringing together global Phase 3 evidence from MIRASOL and SORAYA, alongside supportive data from the Japan-specific TAK-853-1501 study, collectively demonstrating consistent efficacy and a favorable safety profile in FRα-positive platinum-resistant disease
The strength of these findings reflects the biology-driven promise of mirvetuximab soravtansine, a first-in-class FRα-targeted ADC that pairs a high-affinity antibody with a cleavable linker and the maytansinoid payload DM4, enabling selective delivery of a potent tubulin inhibitor to ovarian cancer cells that overexpress FRα
Clinically, the MIRASOL trial has been particularly practice-shaping, showing an overall survival benefit over investigator’s choice chemotherapy in a setting where platinum resistance typically signals rapid disease progression, while SORAYA earlier established meaningful response rates and durability, together underpinning its full FDA approval in the US in 2024 and adoption across more than 40 countries
With orphan drug designation and priority review status from Japan’s Ministry of Health, Labour and Welfare, Takeda’s NDA submission now positions mirvetuximab soravtansine to potentially redefine the standard of care in Japan, reinforcing the growing impact of targeted ADCs in ovarian cancer and highlighting FRα as a clinically actionable biomarker in platinum-resistant disease