The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 26 November 2025, approved inavolisib
(Itovebi) for the treatment of adults with a type of breast
cancer called HR-positive, HER2-negative breast cancer.
Inavolisib is licensed for adults whose breast cancer has come
back, during or soon after
hormone therapy, and has spread to other parts of
the body. It will be available to patients whose cancer
has specific changes in its genes and is not suitable for those
who have recently had certain other cancer treatments.
Inavolisib is a film-coated tablet which is to be
administered orally.
Beach, Interim Executive Director
of Healthcare Quality and Access at the MHRA,
said:
“The approval of inavolisib provides a new targeted treatment for
people with advanced breast cancer that has returned or spread
after hormone therapy.
“Inavolisib can help delay the progression of the disease,
giving patients more time with effective treatment.
“As with all licensed medicines, we will continue to monitor its
safety and effectiveness closely as it becomes more widely
used.”
A full list of side effects can be found in the Patient
Information Leaflet (PIL) or the Summary of Product
Characteristics (SmPC), which will be published on the MHRA
website within 7 days of approval. The most common side effects
include high blood sugar, inflammation of the mouth (stomatitis),
diarrhoea, tiredness, anaemia, nausea, decreased appetite, rash,
headache, weight loss, vomiting and urinary tract
infections.
Anyone who suspects they are having a side effect from this
medicine is encouraged to talk to their
doctor, pharmacist or nurse.
This medicinal product is subject
to additional monitoring. This will allow quick
identification of new safety information. Reporting suspected
adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk
balance of the medicinal product.
Report any suspected adverse reactions to the MHRA 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 approval was granted on 26/11/2025 to ROCHE
PRODUCTS LIMITED.
-
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.
