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.
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.
