Human medicines European public assessment report (EPAR): Elahere, mirvetuximab soravtansine, Date of authorisation: 14/11/2024, Revision: 3, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Elahere is a cancer medicine used for the treatment of adult patients with advanced cancers of the ovaries fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).

Elahere can only be used when the cancer cells have receptors (targets) for proteins called folate-alpha on their surface (folate receptor-alpha (FRα) positive). It is only used when the cancer has become resistant to platinum-based cancer treatment.

Ovarian cancer is rare, and Elahere was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 March 2015.

Elahere contains the active substance mirvetuximab soravtansine.

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How is Elahere used?

Elahere can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer. The doctor will check the levels of FRα before starting treatment.

Elahere is given as an infusion (drip) into a vein. Infusions should be given once every three weeks for as long as the patient benefits from the medicine and tolerates it. The doctor will closely monitor patients for side effects and may interrupt or stop treatment if the patient develops certain serious side effects.

Before giving Elahere the patient should receive medicines to prevent certain side effects such as those related to the infusion, nausea (feeling sick), and vomiting.

Elahere can cause severe eye problems; patients should see an eye specialist before starting treatment and if they develop any new or worsening eye symptoms before each dose. Patients should use eye drops to moisturise the eyes during treatment. In case they develop certain side effects affecting the eyes, the doctor may recommend they use eye drops containing corticosteroids as well.

For more information about using Elahere, see the package leaflet or contact your doctor or pharmacist.

How does Elahere work?

The active substance in Elahere, mirvetuximab soravtansine, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to folate receptors on the surface of cancer cells. When mirvetuximab soravtansine binds to the FRα receptor, it is taken up by the cell where it releases a chemotherapy medicine called DM4. Once inside, DM4 kills the cancer cells by interfering with their ability to divide and grow.

What benefits of Elahere have been shown in studies?

The benefits of Elahere were evaluated in 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, Elahere was compared with standard chemotherapy treatment. Patients who received Elahere lived on average for around 5.6 months without their disease getting worse while those who received standard treatment lived for around 4.0 months without their disease getting worse. In addition, patients who received Elahere lived longer (around 16.5 months) compared to those given standard treatment (around 12.8 months).

What are the risks associated with Elahere?

For the full list of side effects and restrictions with Elahere, see the package leaflet.

The most common side effects with Elahere (which may affect more than 1 in 10 people) were 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 and joint pain.

Some side effects can be serious. Those most frequently reported serious side effects include pneumonitis (inflammation in the lungs), obstruction of the small intestine, obstruction of the intestine pleural effusion (fluid around the lungs), abdominal pain, dehydration, constipation, nausea, ascites (a build-up of fluid in the abdomen) and thrombocytopenia (low levels of blood platelets, components that help the blood to clot).

Why is Elahere authorised in the EU?

Elahere is effective in the treatment of cancer in patients who have ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based treatments. Although there were some study limitations and treatment with Elahere showed limited improvements in delaying the progression of the cancer, the benefit on overall survival rate was significant. These findings are important considering the limited treatment options for these patients.

In terms of safety, Elahere has some important side effects which can be managed by careful monitoring and adjusting the dose of treatment, if needed. Considering how severe the disease is, the side effects of Elahere are considered acceptable.

The European Medicines Agency therefore decided that Elahere’s benefits are greater than its risks and that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Elahere?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elahere have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Elahere are continuously monitored. Suspected side effects reported with Elahere are carefully evaluated and any necessary action taken to protect patients.

Other information about Elahere

Elahere received a marketing authorisation valid throughout the EU on 14 November 2024.

Elahere : EPAR - Medicine overview

Reference Number:

EMA/445004/2024

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Elahere : EPAR - Risk management plan

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Product information

Elahere : EPAR - Product Information

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Latest procedure affecting product information:

VR/0000323227

22/01/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Elahere : EPAR - All authorised presentations

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Product details

Name of medicine

Elahere

Active substance

mirvetuximab soravtansine

International non-proprietary name (INN) or common name

mirvetuximab soravtansine

Therapeutic area (MeSH)

• Ovarian Neoplasms
• Fallopian Tube Neoplasms
• Peritoneal Neoplasms

Anatomical therapeutic chemical (ATC) code

L01FX26

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Elahere as monotherapy is indicated for the treatment of 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.

Authorisation details

EMA product number

EMEA/H/C/005036

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse 67061 Ludwigshafen Germany

Opinion adopted

19/09/2024

Marketing authorisation issued

14/11/2024

Revision

3

Assessment history

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Changes since initial authorisation of medicine

Elahere : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (169.19 KB - PDF)

First published:

20/08/2025

Last updated:

21/09/2026

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Elahere : EPAR - Procedural steps taken and scientific information after authorisation (archive)

English (EN) (143.94 KB - PDF)

First published:

20/08/2025

Last updated:

02/10/2025

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Initial marketing authorisation documents

Elahere : EPAR - Public assessment report

Adopted

Reference Number:

EMA/473768/2024

English (EN) (6.27 MB - PDF)

First published:

11/12/2024

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Elahere : Orphan maintenance assessment report - initial authorisation

Adopted

Reference Number:

EMA/OD/0000178274

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First published:

10/12/2024

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CHMP summary of positive opinion for Elahere

Adopted

Reference Number:

EMA/CHMP/415249/2024

English (EN) (101.53 KB - PDF)

First published:

20/09/2024

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News on Elahere

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024

20/09/2024

More information on Elahere

• EU/3/15/1458 - orphan designation for treatment of ovarian cancer

This page was last updated on

21/09/2026