The Medicines and Healthcare products Regulatory Agency (MHRA) has today (24 July 2025) approved the medicine mirvetuximab soravtansine (Elahere) to treat adults with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
It is used in patients whose cancer cells have a protein on the surface known as folate receptor-alpha (FRα), and who have previously not responded to or are no longer responding to treatment with ‘platinum-based’ chemotherapy, and who have already received one to three prior treatments.
Mirvetuximab soravtansine has been approved via the International Recognition Procedure (IRP).
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
We are committed to making innovative treatment options, like mirvetuximab soravtansine, the first and only folate receptor-alpha (FRα) directed antibody drug conjugate, available to patients as quickly as possible, ensuring our approval is underpinned by robust evidence of efficacy alongside the highest standards of safety.
We’re assured that the appropriate regulatory standards for the approval of mirvetuximab soravtansine have been met.
As with all products, we will keep its safety under close review.
Mirvetuximab soravtansine is administered as a concentrated solution for infusion, and the route of administration is intravenous infusion (into a vein). The medicine will be given to the patient by a doctor or a nurse experienced in using cancer medicines.
The patient’s doctor will calculate the dose based on the patient’s body weight. The patient’s doctor will decide how many cycles the patient needs.
Mirvetuximab soravtansine is made up of a monoclonal antibody which is attached to a cancer medicine. The monoclonal antibody is a protein that recognises and attaches to the FRα protein on the cancer cells. When this happens, mirvetuximab soravtansine enters the cancer cell and releases the cancer medicine DM4. DM4 then interferes with the normal growth process of the cancer cells which results in death of the cancer cells.
This approval is supported by evidence from a study involving 453 adults with advanced platinum-resistant cancers of the ovary, fallopian tubes and the peritoneum that were FRα positive. In this study, mirvetuximab soravtansine was compared with standard chemotherapy treatment. Patients who received mirvetuximab soravtansine lived on average for around 5.6 months without their disease getting worse while those who received standard treatment lived for around 4 months without their disease getting worse. In addition, patients who received mirvetuximab soravtansine lived longer (around 16.5 months) compared to those given standard treatment (around 12.8 months).
The most common side effects of the medicine (which may affect more than 1 in 10 people) include blurred vision, nausea (feeling sick), diarrhoea, tiredness, abdominal pain (belly pain), keratopathy (damage to the cornea, the transparent layer in front of the eye that covers the pupil and iris), dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy (nerve damage in arms and legs), headache, weakness, increased liver enzyme levels (in the blood) and joint pain.
As with any medicine, the MHRA will keep the safety and effectiveness of mirvetuximab soravtansine under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
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The new marketing authorisation was granted on 24 July 2025 to AbbVie Ltd.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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More information on the International Recognition Procedure can be found here
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
