European Commission Approves AbbVie's ELAHERE® For Advanced Ovarian Cancer

AbbVie has received marketing authorization from the European Commission (EC) for ELAHERE® (mirvetuximab soravtansine). This approval marks a significant milestone, making ELAHERE the first and only antibody-drug conjugate (ADC) targeting folate receptor-alpha (FRα) to be approved in the European Union, as well as in Iceland, Liechtenstein, Norway, and Northern Ireland. The treatment is indicated for adult patients with FRα-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three prior systemic therapies.

Ovarian cancer ranks among the deadliest gynaecological cancers globally. The majority of cases are diagnosed at an advanced stage, with standard treatment involving surgery and platinum-based chemotherapy. However, resistance to platinum therapy eventually emerges in most patients, leaving them with limited options. Treatment for platinum-resistant ovarian cancer (PROC) has traditionally been challenging, often associated with significant side effects that compromise patients’ quality of life.

Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven, said in a statement, “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.”

Clara Mackay, CEO, World Ovarian Cancer Coalition, mentioned, “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. 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.”

Around one-third of ovarian cancer patients exhibit high levels of folate receptor-alpha (FRα) expression, defined as ≥75% of tumor cells showing ≥2+ membrane staining intensity.iv Biomarker testing can be performed using Roche's VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay, either at diagnosis or when signs of resistance to platinum-based chemotherapy emerge. AbbVie partnered with Roche Diagnostics to develop this recently approved immunohistochemistry (IHC) companion diagnostic, designed to help identify patients who may benefit from treatment with ELAHERE.

“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," stated, Roopal Thakkar, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie.