AbbVie has announced that the European Commission (EC) has granted marketing authorization for ELAHERE (mirvetuximab soravtansine) for adult patients with folate receptor-alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The approval applies to patients who have undergone one to three prior systemic treatments and extends to the European Union, as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
This marks a major milestone, as ELAHERE is the first new treatment for platinum-resistant ovarian cancer approved in the EU in over a decade. “Oncologists now have an effective, targeted treatment option for these patients,” said Professor Toon Van Gorp, a gynecological oncology expert at the University of Leuven.
Ovarian cancer remains a leading cause of death among gynecological cancers, with many patients presenting in advanced stages. While initial treatment typically involves surgery and platinum-based chemotherapy, most patients eventually develop platinum-resistant disease. Historically, options for platinum-resistant ovarian cancer (PROC) have been limited, often carrying significant side effects that compromise quality of life.
Clara Mackay, CEO of the World Ovarian Cancer Coalition, highlighted the devastating impact of ovarian cancer: “In Europe, ovarian cancer is three times more deadly than breast cancer. New treatment options like ELAHERE provide hope for better survival and improved quality of life for patients worldwide.”
Approximately one-third of ovarian cancer patients exhibit high levels of the FRα biomarker, which is critical for ELAHERE eligibility. Patients can be tested using Roche’s VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, a companion diagnostic developed in collaboration with AbbVie to identify suitable candidates.
The EC’s approval is based on data from the global Phase 3 MIRASOL trial. The study demonstrated significant efficacy, with ELAHERE reducing the risk of disease progression or death by 35% compared to investigator-choice (IC) chemotherapy [HR 0.65; p<0.0001] and lowering the risk of death by 33% [HR 0.67; p=0.0046]. ELAHERE also improved overall survival (OS) and progression-free survival (PFS).
As reported by medicaldialogues, the most common side effects associated with ELAHERE include blurred vision, fatigue, nausea, keratopathy, and abdominal pain, with pneumonitis being the most frequently reported serious adverse event.
These findings, presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, underscore ELAHERE’s potential to transform the treatment landscape for platinum-resistant ovarian cancer.
Dr. Roopal Thakkar, AbbVie’s Chief Scientific Officer, emphasized the significance of this approval: “ELAHERE provides a much-needed option for patients facing the daunting challenge of recurrent, platinum-resistant ovarian cancer.”