European Commisson approves Elahere (mirvetuximab soravtansine) for FRα positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer – Abbvie

AbbVie  announced the European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first and only folate receptor alpha (FRɑ)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland.

“It’s been 10 years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients,” said Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven.

Ovarian cancer is one of the leading causes of death from gynecological cancers worldwideⁱ Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, most patients eventually develop platinum-resistant disease. Historically, treatment options for patients with platinum-resistant ovarian cancer (PROC) have been limited, and those available often result in adverse events which can negatively impact quality of life.

In approximately one third of people living with ovarian cancer, the folate-receptor alpha (FRα) biomarker is highly expressed (≥75% of tumor cells with ≥2+ membrane staining intensity). To determine biomarker status, patients can be tested with Roche’s Ventana FOLR1 (FOLR1-2.1) RxDx Assay at diagnosis or at the first sign of resistance to platinum-based chemotherapy. AbbVie collaborated with Roche Diagnostics on the newly approved immunohistochemistry (IHC) companion diagnostic test to identify patients who may be eligible for Elahere.

The marketing authorization of ELAHERE is supported by data from MIRASOL: a global, Phase III open-label, randomized, controlled trial..