Takeda Announces Launch of ELAHERE® (mirvetuximab soravtansine) in Japan for the Treatment of Folate Receptor Alpha-Positive, Platinum-Resistant Recurrent Ovarian Cancer

November 13, 2026

Takeda (TSE:4502/NYSE:TAK) announced the launch of ELAHERE® Intravenous Infusion 100 mg (generic name: mirvetuximab soravtansine [genetical recombination]), an antibody-drug conjugate (ADC) that binds to folate receptor alpha (FRα), with an indication for FRα-positive, platinum-resistant recurrent ovarian cancer (PROC). ELAHERE is the first and only ADC approved in Japan for the treatment of FRα-positive PROC.

ELAHERE received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare on September 16, 2026. The approval was based on results from the MIRASOL and SORAYA trials, global studies in patients with FRα-positive PROC, as well as the TAK-853-1501 trial, a Phase 1/2 study conducted in Japan.

VENTANA OptiView FOLR1 (FOLR1-2.1) , a companion diagnostic developed by Roche Diagnostics K.K. and launched on November 1, 2026, is used to support the assessment of ELAHERE treatment eligibility in patients with FRα-positive PROC.

Ovarian cancer is a malignant tumor that arises from various cell types in and on the ovaries, and it has been reported that approximately one third of patients with ovarian cancer have high FRα expression¹ (≥75% of viable tumor cells with ≥2+ membrane staining intensity). In Japan, 12,926 cases were diagnosed with ovarian cancer in 2023.²Many patients remain asymptomatic as the disease progresses, and effective preventive methods such as screening for early detection have not yet been established. While advanced ovarian cancer generally responds well to first-line treatment, over 80% of patients experience recurrence.^{3, 4}

“We are very pleased to bring ELAHERE as a new treatment option to patients in Japan with FRα-positive PROC. We hope that ELAHERE will provide new value to patients and their families in this area of significant unmet need, where effective treatment options remain limited at recurrence, and contribute to the advancement of biomarker-based personalized medicine. We remain committed to addressing patients' needs through innovative cancer treatments and working toward a better future,” said Yuji Liguori, Head of Japan Oncology Business Unit at Takeda.

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.

Product Overview of ELAHERE® in Japan

Product Name
ELAHERE® Intravenous Infusion 100 mg
Generic Name
mirvetuximab soravtansine (genetical recombination)
Indication
Folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer
Dosage and Administration
The recommended adult dosage is 6 mg/kg adjusted ideal body weight (AIBW) of mirvetuximab soravtansine (genetical recombination) administered once every 3 weeks as an intravenous infusion. The dose may be reduced according to the patient's condition.
The total dose for single administration is calculated based on each patient’s AIBW using the following formula.
AIBW[kg] = Ideal Body Weight (IBW [kg]) + 0.4 × (Actual weight [kg] - IBW [kg])
Female IBW (kg) = 0.9 × height [cm] - 92
NHI Drug Price
502,832 yen

About the Companion Diagnostic VENTANA OptiView FOLR1 (FOLR1-2.1)

VENTANA OptiView FOLR1 (FOLR1-2.1) developed by Roche Diagnostics K.K. is a companion diagnostic that evaluates the expression of folate receptor alpha protein (FOLR1 protein) in tumor tissue using an immunohistochemistry (IHC) assay and is used to support the assessment of ELAHERE® (generic name: mirvetuximab soravtansine [genetical recombination]) treatment eligibility in patients with folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer. VENTANA OptiView FOLR1 (FOLR1-2.1) received manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare on July 30, 2026, and was launched on November 1, 2026.

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://www.clinicaltrials.gov/ (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.

Takeda Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Takeda Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at https://www.sec.gov/. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Takeda Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

References

Markert S, Lassmann S, Gabriel B, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Research. 2008;28(6A):3567–3572.
国立研究開発法人国立がん研究センター. がん情報サービス. がん種別統計情報. 卵巣.
Lisio MA, Fu L, Goyeneche A, Gao ZH, Telleria C. High-Grade Serous Ovarian Cancer: Basic Sciences, Clinical and Therapeutic Standpoints. Int J Mol Sci. 2019;20(4):952. doi:10.3390/ijms20040952
Matulonis UA, Sood AK, Fallowfield L, Howitt BE, Sehouli J, Karlan BY. Ovarian Cancer. Nat Rev Dis Primers. 2016;2:16061. doi:10.1038/nrdp.2016.61

Takeda ([TSE:4502/NYSE:TAK](/investors/overview/)) announced the launch of ELAHERE® Intravenous Infusion 100 mg (generic name: mirvetuximab soravtansine [genetical recombination]), an antibody-drug conjugate (ADC) that binds to folate receptor alpha (FRα), with an indication for FRα-positive, platinum-resistant recurrent ovarian cancer (PROC). ELAHERE is the first and only ADC approved in Japan for the treatment of FRα-positive PROC. ELAHERE received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare on September 16, 2026. The approval was based on results from the MIRASOL and SORAYA trials, global studies in patients with FRα-positive PROC, as well as the TAK-853-1501 trial, a Phase 1/2 study conducted in Japan. VENTANA OptiView FOLR1 (FOLR1-2.1) , a companion diagnostic developed by Roche Diagnostics K.K. and launched on November 1, 2026, is used to support the assessment of ELAHERE treatment eligibility in patients with FRα-positive PROC. Ovarian cancer is a malignant tumor that arises from various cell types in and on the ovaries, and it has been reported that approximately one third of patients with ovarian cancer have high FRα expression1 (≥75% of viable tumor cells with ≥2+ membrane staining intensity). In Japan, 12,926 cases were diagnosed with ovarian cancer in 2023.2 Many patients remain asymptomatic as the disease progresses, and effective preventive methods such as screening for early detection have not yet been established. While advanced ovarian cancer generally responds well to first-line treatment, over 80% of patients experience recurrence.3, 4 “We are very pleased to bring ELAHERE as a new treatment option to patients in Japan with FRα-positive PROC. We hope that ELAHERE will provide new value to patients and their families in this area of significant unmet need, where effective treatment options remain limited at recurrence, and contribute to the advancement of biomarker-based personalized medicine. We remain committed to addressing patients' needs through innovative cancer treatments and working toward a better future,” said Yuji Liguori, Head of Japan Oncology Business Unit at Takeda. ## 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. ## Product Overview of ELAHERE® in Japan * **Product Name** ELAHERE® Intravenous Infusion 100 mg * **Generic Name** mirvetuximab soravtansine (genetical recombination) * **Indication** Folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer * **Dosage and Administration** The recommended adult dosage is 6 mg/kg adjusted ideal body weight (AIBW) of mirvetuximab soravtansine (genetical recombination) administered once every 3 weeks as an intravenous infusion. The dose may be reduced according to the patient's condition. The total dose for single administration is calculated based on each patient’s AIBW using the following formula. AIBW[kg] = Ideal Body Weight (IBW [kg]) + 0.4 × (Actual weight [kg] - IBW [kg]) Female IBW (kg) = 0.9 × height [cm] - 92 * **NHI Drug Price** 502,832 yen ## About the Companion Diagnostic VENTANA OptiView FOLR1 (FOLR1-2.1) VENTANA OptiView FOLR1 (FOLR1-2.1) developed by Roche Diagnostics K.K. is a companion diagnostic that evaluates the expression of folate receptor alpha protein (FOLR1 protein) in tumor tissue using an immunohistochemistry (IHC) assay and is used to support the assessment of ELAHERE® (generic name: mirvetuximab soravtansine [genetical recombination]) treatment eligibility in patients with folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer. VENTANA OptiView FOLR1 (FOLR1-2.1) received manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare on July 30, 2026, and was launched on November 1, 2026. ## 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://www.clinicaltrials.gov/ (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](/). ## Takeda Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. ## Takeda Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [https://www.takeda.com/investors/sec-filings-and-security-reports/](/investors/sec-filings-and-security-reports/) or at https://www.sec.gov/. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. ## Takeda Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. ## References 1. Markert S, Lassmann S, Gabriel B, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Research. 2008;28(6A):3567–3572. 2. 国立研究開発法人国立がん研究センター. がん情報サービス. がん種別統計情報. 卵巣. 3. Lisio MA, Fu L, Goyeneche A, Gao ZH, Telleria C. High-Grade Serous Ovarian Cancer: Basic Sciences, Clinical and Therapeutic Standpoints. Int J Mol Sci. 2019;20(4):952. doi:10.3390/ijms20040952 4. Matulonis UA, Sood AK, Fallowfield L, Howitt BE, Sehouli J, Karlan BY. Ovarian Cancer. Nat Rev Dis Primers. 2016;2:16061. doi:10.1038/nrdp.2016.61

Takeda Announces Launch of ELAHERE® (mirvetuximab soravtansine) in Japan for the Treatment of Folate Receptor Alpha-Positive, Platinum-Resistant Recurrent Ovarian Cancer | Takeda Pharmaceuticals