AbbVie has received European Commission (EC) marketing authorization for ELAHERE (mirvetuximab soravtansine) for the treatment of platinum-resistant ovarian cancer. The approval marks the first folate receptor alpha (FRɑ)-directed antibody drug conjugate approved in the European Union, Iceland, Liechtenstein, Norway, and Northern Ireland.
The treatment specifically targets 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.
“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.
The approval addresses a critical need in ovarian cancer treatment. “Ovarian cancer can be devastating, taking women away from precious moments with their family, disrupting careers and the many other important contributions that women make to society,” said Clara Mackay, CEO, World Ovarian Cancer Coalition. “In Europe, ovarian cancer is three times more deadly than breast cancer, and having new innovative options allows us to work toward a world where everyone living with ovarian cancer has the best chance of survival and the best quality of life possible, no matter where they live.”
“The approval of ELAHERE by the European Commission provides a much needed clinically meaningful option for patients who receive the heartbreaking news their ovarian cancer has returned, fearing what’s next in their treatment journey after they’ve developed platinum-resistance,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.
The approval is supported by data from the MIRASOL Phase 3 trial, which demonstrated a 35% reduction in the risk of tumor progression or death in patients treated with ELAHERE compared to investigator’s choice chemotherapy. The trial also showed a 33% reduction in the risk of death in the ELAHERE arm.
Alongside the drug approval, Roche’s VENTANA FOLR1 (FOLR1-2.1) RxDx Assay received CE Mark approval. This companion diagnostic test helps identify ovarian cancer patients eligible for ELAHERE by detecting the FRα biomarker, which is highly expressed in approximately one-third of people living with ovarian cancer.
