The approval is supported by a study involving 453 adults with
advanced platinum-resistant cancers of the ovary, fallopian tubes
and the peritoneum that were FRα positive.
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).
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
-
The new marketing authorisation was granted on 24 July 2025
to AbbVie Ltd.
-
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.
-
More information on the International Recognition Procedure
can be found here
