Takeda Submits New Drug Application for Mirvetuximab Soravtansine for Folate Receptor Alpha-Positive, Platinum-Resistant Recurrent Ovarian Cancer in Japan

2026年1月30日

Mirvetuximab soravtansine, a first‑in‑class antibody–drug conjugate (ADC) in the field of ovarian cancer.
This New Drug Application (NDA) highlights the potential of mirvetuximab soravtansine to provide a new treatment option for patients with folate receptor alpha (FRα)-positive, platinum‑resistant recurrent ovarian cancer and to address a significant unmet medical need.

OSAKA, Japan, January 30, 2026 – Takeda (TSE:4502/NYSE:TAK) (“Takeda”) today announced it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for mirvetuximab soravtansine for folate receptor alpha (FRα)-positive, platinum-resistant recurrent ovarian cancer (PROC) in Japan.

The NDA submission is based on the results of the MIRASOL and SORAYA trials, which are global Phase 3 studies in patients with FRα-positive PROC, as well as the TAK-853-1501 trial, a domestic Phase 1/2 study. Across these trials, mirvetuximab soravtansine demonstrated consistent efficacy and a favorable safety profile in the treatment of patients with FRα-positive PROC.

"In Japan, treatment options for patients resistant to platinum at relapse are limited, and the prognosis remains poor. This represents a significant unmet medical need, and new therapies are eagerly awaited. We are pleased that through this NDA submission based upon compelling data in the MIRASOL, SORAYA, and TAK-853-1501 trials, we have taken an important step toward delivering mirvetuximab soravtansine to patients in Japan," said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit at Takeda.

Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) in the field of ovarian cancer. In the U.S., it received accelerated approval in November 2022 and full approval in March 2024 for the treatment of FRα-positive, platinum-resistant epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer in patients with one to three prior lines of chemotherapy. As of January 2026, mirvetuximab soravtansine is approved as a treatment for PROC in more than 40 countries or regions, including the U.S. and the EU. Takeda holds an exclusive license in Japan to develop and commercialize mirvetuximab soravtansine in all indications. Mirvetuximab soravtansine has been designated as an orphan drug by the MHLW for the anticipated indication of FRα-positive recurrent ovarian cancer, and this application is subject to priority review.

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 FRα ^{1, 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 first-line treatment for ovarian cancer is generally effective, recurrence is observed in more than 80% of patients ^{3, 4}. In Japan, 13,456 cases were diagnosed with ovarian cancer in 2021 ⁵. Ovarian cancer is often diagnosed at an advanced stage (Stage III or IV) at the time of initial diagnosis, and although the current standard of care with chemotherapy including platinum-based agents is initially effective, but it is reported that the effect of platinum eventually diminishes ⁶. The 5-year survival rates are 54.4% for stage III and 45.2% for stage IV ⁷. Platinum resistance is defined as recurrence within six months after the last administration of a platinum-based agent, and current treatment options and their effectiveness are limited.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. In November 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval for mirvetuximab soravtansine as a treatment for FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with one to three prior lines of chemotherapy, based on data from the pivotal SORAYA trial on objective response rate (ORR) and duration. Based on the results from the MIRASOL trial, a Phase 3 study comparing the safety and efficacy of mirvetuximab soravtansine with existing chemotherapy in patients with FRα-positive, platinum-resistant recurrent ovarian cancer (PROC), mirvetuximab soravtansine demonstrated an improvement in overall survival (OS) over investigator’s choice of single-agent chemotherapy and it was approved in the U.S. as a new treatment option in March 2024.

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 cells with ≥2+ staining intensity), confirmed 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 cells with ≥2+ 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 in the treatment of platinum-resistant, high-grade serous ovarian cancer whose tumors express high levels of FRα (≥75% of cells with ≥2+ 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 in Japanese patients, both of which were consistent with those observed in overseas clinical studies.

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 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

Parker N, Turk MJ, Westrick E, Lewis JD, Low PS, Leamon CP. Anal Biochem. 2005;338(2):284-293. doi:10.1016/j.ab.2004.12.026.
Toffoli G, Cernigoi C, Russo A, Gallo A, Bagnoli M, Boiocchi M. Int J Cancer. 1997;74(2):193-198. doi:10.1002/(sici)1097-0215(19970422)74:2<193::aid-ijc10>3.0.co;2-f.
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.
Matulonis UA, Sood AK, Fallowfield L, Howitt BE, Sehouli J, Karlan BY. Ovarian cancer. Nat Rev Dis Primers. 2016;2:16061.
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.
Hanker LC, Loibl S, Burchardi N, et al. Ann Oncol. 2012;23(10):2605-2612. doi:10.1093/annonc/mds203.
日本産科婦人科学会. 婦人科腫瘍委員会報告. 第65回治療年報. 日産婦誌. 2025; 77(3): 466-581.

* Mirvetuximab soravtansine, a first‑in‑class antibody–drug conjugate (ADC) in the field of ovarian cancer. * This New Drug Application (NDA) highlights the potential of mirvetuximab soravtansine to provide a new treatment option for patients with folate receptor alpha (FRα)-positive, platinum‑resistant recurrent ovarian cancer and to address a significant unmet medical need. **OSAKA, Japan, January 30, 2026** – Takeda ([TSE:4502/NYSE:TAK](/investors/overview/)) (“Takeda”) today announced it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for mirvetuximab soravtansine for folate receptor alpha (FRα)-positive, platinum-resistant recurrent ovarian cancer (PROC) in Japan. The NDA submission is based on the results of the MIRASOL and SORAYA trials, which are global Phase 3 studies in patients with FRα-positive PROC, as well as the TAK-853-1501 trial, a domestic Phase 1/2 study. Across these trials, mirvetuximab soravtansine demonstrated consistent efficacy and a favorable safety profile in the treatment of patients with FRα-positive PROC. "In Japan, treatment options for patients resistant to platinum at relapse are limited, and the prognosis remains poor. This represents a significant unmet medical need, and new therapies are eagerly awaited. We are pleased that through this NDA submission based upon compelling data in the MIRASOL, SORAYA, and TAK-853-1501 trials, we have taken an important step toward delivering mirvetuximab soravtansine to patients in Japan," said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit at Takeda. Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) in the field of ovarian cancer. In the U.S., it received accelerated approval in November 2022 and full approval in March 2024 for the treatment of FRα-positive, platinum-resistant epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer in patients with one to three prior lines of chemotherapy. As of January 2026, mirvetuximab soravtansine is approved as a treatment for PROC in more than 40 countries or regions, including the U.S. and the EU. Takeda holds an exclusive license in Japan to develop and commercialize mirvetuximab soravtansine in all indications. Mirvetuximab soravtansine has been designated as an orphan drug by the MHLW for the anticipated indication of FRα-positive recurrent ovarian cancer, and this application is subject to priority review. ## 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 FRα 1, 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 first-line treatment for ovarian cancer is generally effective, recurrence is observed in more than 80% of patients 3, 4. In Japan, 13,456 cases were diagnosed with ovarian cancer in 2021 5. Ovarian cancer is often diagnosed at an advanced stage (Stage III or IV) at the time of initial diagnosis, and although the current standard of care with chemotherapy including platinum-based agents is initially effective, but it is reported that the effect of platinum eventually diminishes 6. The 5-year survival rates are 54.4% for stage III and 45.2% for stage IV 7. Platinum resistance is defined as recurrence within six months after the last administration of a platinum-based agent, and current treatment options and their effectiveness are limited. ## About Mirvetuximab Soravtansine Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. In November 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval for mirvetuximab soravtansine as a treatment for FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with one to three prior lines of chemotherapy, based on data from the pivotal SORAYA trial on objective response rate (ORR) and duration. Based on the results from the MIRASOL trial, a Phase 3 study comparing the safety and efficacy of mirvetuximab soravtansine with existing chemotherapy in patients with FRα-positive, platinum-resistant recurrent ovarian cancer (PROC), mirvetuximab soravtansine demonstrated an improvement in overall survival (OS) over investigator’s choice of single-agent chemotherapy and it was approved in the U.S. as a new treatment option in March 2024. ## 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 cells with ≥2+ staining intensity), confirmed 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 cells with ≥2+ 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 in the treatment of platinum-resistant, high-grade serous ovarian cancer whose tumors express high levels of FRα (≥75% of cells with ≥2+ 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 in Japanese patients, both of which were consistent with those observed in overseas clinical studies. 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 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. Parker N, Turk MJ, Westrick E, Lewis JD, Low PS, Leamon CP. Anal Biochem. 2005;338(2):284-293. doi:10.1016/j.ab.2004.12.026. 2. Toffoli G, Cernigoi C, Russo A, Gallo A, Bagnoli M, Boiocchi M. Int J Cancer. 1997;74(2):193-198. doi:10.1002/(sici)1097-0215(19970422)74:2<193::aid-ijc10>3.0.co;2-f. 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. 4. Matulonis UA, Sood AK, Fallowfield L, Howitt BE, Sehouli J, Karlan BY. Ovarian cancer. Nat Rev Dis Primers. 2016;2:16061. 5. 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. 6. Hanker LC, Loibl S, Burchardi N, et al. Ann Oncol. 2012;23(10):2605-2612. doi:10.1093/annonc/mds203. 7. 日本産科婦人科学会. 婦人科腫瘍委員会報告. 第65回治療年報. 日産婦誌. 2025; 77(3): 466-581.

Takeda Submits New Drug Application for Mirvetuximab Soravtansine for Folate Receptor Alpha-Positive, Platinum-Resistant Recurrent Ovarian Cancer in Japan | Takeda Pharmaceuticals