Authorization Granted: AbbVie's ELAHERE receives MHRA marketing approval
New Treatment for Platinum-Resistant Ovarian Cancer Awaits NICE and SMC Appraisal in the UK
AbbVie's mirvetuximab soravtansine (ELAHEARE) has received regulatory approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for use in adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer who have high folate receptor-alpha expression and have received one to three prior systemic treatments. However, as of August 2025, the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) have not completed their appraisals on the medicine, and no guidance on cost-effectiveness or reimbursement has been published yet.
The MHRA approval, granted in July 2025, marks the first new licensed treatment for platinum-resistant ovarian cancer in the UK in 10 years. The drug is indicated for patients who have cancer cells expressing high levels of folate receptor-alpha and who no longer respond to platinum-based chemotherapy.
Ovarian cancer is one of the leading causes of death from gynaecological cancer in the UK. The disease often presents in late-stage disease, and 80% of women with advanced disease relapse and develop resistance to treatment, resulting in a poor prognosis.
AbbVie is working to complete the appraisal process with NICE and the SMC as thoroughly and efficiently as possible. The ongoing development program for mirvetuximab soravtansine includes evaluating it in combination with other therapies. Clinical trials are underway to explore the use of mirvetuximab soravtansine in combination therapy, in the second line plus platinum-sensitive and first-line maintenance settings. Mirvetuximab soravtansine is also being evaluated for use in FRα medium expressors.
Treatment options for patients with platinum-resistant ovarian cancer (PROC) have been limited historically, and those available often result in adverse events that negatively impact quality of life. The approval of mirvetuximab soravtansine provides a new treatment option for eligible people living with this type of ovarian cancer in the UK.
A global patient access scheme is in place for mirvetuximab soravtansine, and individual patients must speak with their clinicians for further guidance. It's important to note that, as of now, mirvetuximab soravtansine is not yet reimbursed for use on the NHS in England or Scotland.
The appraisal process by NICE and the SMC is an essential step in determining the cost-effectiveness and reimbursement of the drug on the NHS. Once the appraisals are completed, the UK's health authorities will issue guidance on the use and funding of mirvetuximab soravtansine. Until then, patients and their clinicians should continue to monitor the situation closely.
Femtech news highlights the ongoing appraisal by the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) for AbbVie's new treatment, mirvetuximab soravtansine, in the UK, which could revolutionize the health-and-wellness landscape for women dealing with ovarian cancer, a medical-condition that is one of the leading causes of death from Gynae-cancer in the UK and often presents in late-stage disease. Clinical trials are underway to evaluate the use of mirvetuximab soravtansine in combination therapy for platinum-resistant ovarian cancer, offering a potential alternative to the limited options available for this cancer, often associated with adverse events impacting quality of life.
