Takeda Receives Approval for ELAHERE® (mirvetuximab soravtansine) in Japan for the Treatment of Folate Receptor Alpha-Positive, Platinum-Resistant Recurrent Ovarian Cancer
Takeda Receives Approval for ELAHERE® (mirvetuximab soravtansine) in Japan for the Treatment of Folate Receptor Alpha-Positive, Platinum-Resistant Recurrent Ovarian Cancer
- ELAHERE (mirvetuximab soravtansine) is the first and only antibody-drug conjugate (ADC) approved in Japan for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant recurrent ovarian cancer (PROC), with the potential to address a significant unmet medical need.
- The approval is based on results from the MIRASOL and SORAYA trials, global Phase 3 studies in patients with FRα-positive PROC, as well as the TAK-853-1501 trial, a Phase 1/2 study conducted in Japan.
Takeda (TSE:4502/NYSE:TAK) announced that it has received manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for ELAHERE® Intravenous Infusion 100 mg (generic name: mirvetuximab soravtansine [genetical recombination]), an antibody-drug conjugate (ADC) that binds to folate receptor alpha (FRα), for the treatment of FRα-positive, platinum-resistant recurrent ovarian cancer (PROC).
This approval is based on results from the studies in patients with FRα-positive PROC, global Phase 3 MIRASOL and SORAYA trials, and TAK-853-1501 trial, a Phase 1/2 study conducted exclusively in Japan. In the MIRASOL trial, patients with FRα-positive PROC who had received one to three prior lines of chemotherapy were randomized to receive either mirvetuximab soravtansine or investigator’s choice of single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). Mirvetuximab soravtansine demonstrated benefits in progression-free survival (PFS), the primary endpoint, and overall survival (OS), a key secondary endpoint. Ocular and gastrointestinal adverse events and peripheral neuropathy observed in the mirvetuximab soravtansine arm were predominantly low-grade, and the incidence of adverse events leading to treatment discontinuation was 9% in the mirvetuximab soravtansine arm, compared with 16% in the single-agent chemotherapy arm. Data from the MIRASOL trial were published in The New England Journal of Medicine in December 2023.¹ In the Phase 2 part of the Phase 1/2 TAK-853-1501 trial conducted in Japan, mirvetuximab soravtansine demonstrated efficacy and a safety profile consistent with those observed in the global Phase 3 MIRASOL and SORAYA trials.
“Ovarian cancer is associated with a high rate of recurrence, and effective treatment options have been limited, particularly for patients with PROC, making treatment decisions challenging in many cases. The approval of ELAHERE as a new treatment option represents an important step forward in providing the most appropriate treatment for individual patients, and I hope it will bring new hope to patients and their families,” said Aikou Okamoto, M.D., President of the Japanese Gynecologic Oncology Group (JGOG) and Professor at the International University of Health and Welfare, who served as the principal investigator for the Phase 2 part of the TAK-853-1501 trial.
“We are thrilled to bring ELAHERE to patients in Japan as the country's first and only ADC for FRα-positive, PROC. For women who have had few effective choices at relapse, this biomarker-directed therapy offers a genuinely new way forward — one built on the strength of the MIRASOL, SORAYA, and TAK-853-1501 data. This approval reflects Takeda's deep commitment to pioneering novel oncology therapies and to translating cutting-edge science into meaningful outcomes for patients in Japan and around the world,” said Phuong Khanh (P.K.) Morrow, M.D., Global Head of the Oncology Therapeutic Area Unit at Takeda.
As of September 2026, mirvetuximab soravtansine is approved as a treatment for FRα-positive PROC in more than 50 countries or regions, including the U.S. and the EU. AbbVie and its affiliates hold the rights to businesses related to mirvetuximab soravtansine in those countries or regions. Takeda holds an exclusive license in Japan to develop and commercialize mirvetuximab soravtansine.
About Ovarian Cancer
Ovarian cancer is a cancerous tumor that begins on the surface of the ovaries and in the ovaries, and approximately 90% of ovarian cancers have been reported to express folate receptor alpha.2, 3 Many patients remain asymptomatic as the disease progresses, and effective preventive methods such as screening for early detection have not yet been established. While first-line treatment for ovarian cancer is generally effective, disease progression or recurrence is observed in more than 80% of patients.4, 5 In Japan, 12,926 cases were diagnosed with ovarian cancer in 2023.6 Ovarian cancer is often initially diagnosed at an advanced stage (Stage III or IV), and although the current standard of care with chemotherapy including platinum-based agents is often effective initially, it is reported that the effect of platinum eventually diminishes.7 Platinum resistance is defined as recurrence within six months after the last administration of a platinum-based agent. The 5-year survival rates are 54.4% for stage III and 45.2% for stage IV.8
About ELAHERE® (mirvetuximab soravtansine)
ELAHERE is an antibody-drug conjugate (ADC) comprising a monoclonal antibody that binds to folate receptor alpha (FRα), linked via a cleavable linker to the potent maytansinoid payload DM4, which is designed to target cancer cells. After binding to FRα, ELAHERE is internalized into the cell, where the released DM4 inhibits cell division, thereby suppressing the growth of cancer cells.
About the MIRASOL Study
MIRASOL is a global Phase 3 open-label, randomized, controlled trial to compare the efficacy and safety of mirvetuximab soravtansine with the investigator's choice of single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous ovarian cancer whose tumors express high levels of FRα (≥75% of viable tumor cells with ≥2+ membrane staining intensity) with a validated test. Participants had previously received one to three lines of prior therapy. The primary endpoint was investigator-assessed progression-free survival (PFS). Key secondary endpoints included objective response rate (ORR) and overall survival (OS).
More information can be found on https://clinicaltrials.gov/study/ (NCT 04209855).
About the SORAYA Study
SORAYA is a global Phase 3 single-arm trial to evaluate the efficacy and safety of mirvetuximab soravtansine in the treatment of platinum-resistant, high-grade serous ovarian cancer whose tumors express high levels of FRα (≥75% of viable tumor cells with ≥2+ membrane staining intensity), confirmed with a validated test. Participants had previously received one to three lines of prior therapy, including at least one line with bevacizumab. The primary endpoint was investigator-assessed objective response rate (ORR), and the secondary endpoint was duration of response (DOR).
More information can be found on https://www.clinicaltrials.gov/ (NCT 04296890).
About the TAK-853-1501 Study
TAK-853-1501 is a Phase 1/2 single-arm study conducted in Japanese patients to evaluate the safety, efficacy, and pharmacokinetics of mirvetuximab soravtansine. In the Phase 1 part, tolerability and safety of mirvetuximab soravtansine were assessed in Japanese patients with FRα-positive advanced ovarian cancer or other solid tumors. The primary endpoint of the Phase 1 part was safety, and secondary endpoints included pharmacokinetic parameters. In the Phase 2 part, efficacy and safety of mirvetuximab soravtansine were evaluated in the treatment of platinum-resistant, high-grade serous ovarian cancer whose tumors express high levels of FRα (≥75% of viable tumor cells with ≥2+ membrane staining intensity). The primary endpoint of the Phase 2 part was investigator-assessed objective response rate (ORR), and secondary endpoints included duration of response (DOR). The results demonstrated efficacy and a safety profile consistent with those observed in the global Phase 3 MIRASOL and SORAYA trials.
More information can be found on https://www.clinicaltrials.gov/ (NCT 06390995).
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
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