ELAHERE is intended to treat patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Credit: Chinnapong / Shutterstock.com.

The European Medicines Agency (EMA) has accepted ImmunoGen’s marketing authorisation application (MAA) for mirvetuximab soravtansine (ELAHERE) to treat patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

ELAHERE is a first-in-class antibody-drug conjugate (ADC) composed of a folate receptor alpha-binding antibody, the maytansinoid payload DM4 and a cleavable linker.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

DM4 is a potent tubulin inhibitor designed to eliminate the targeted cancer cells.

The MAA has been accepted based on data from the Phase III MIRASOL study of the therapy in patients with platinum-resistant ovarian cancer.

ELAHERE showed improvements in overall survival, progression-free survival and objective response rate in the trial compared to the investigator’s choice (IC) of single-agent chemotherapy.

It also showed a tolerable safety profile against IC chemotherapy comprising low-grade ocular and gastrointestinal events.

ImmunoGen research, development and medical affairs executive vice-president Michael Vasconcelles stated: “As the first novel medicine to have demonstrated an overall survival benefit in platinum-resistant ovarian cancer compared to chemotherapy in a Phase III clinical trial, we are pleased to initiate the review process that moves us one step closer to providing access to ELAHERE for eligible patients in Europe.

“We look forward to working closely with the EMA throughout the review process and to potentially bring this novel ADC to Europe as early as 2024.”

In November 2022, the company received approval from the US Food and Drug Administration (FDA) for ELAHERE.