LONDON, Nov. 26 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today,26 November2025, 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 hormonetherapy,andhas spread to other parts of the body. Itwill be available topatients whose cancer has specific changes in its genes and is not suitable for those who have recently had certain other cancer treatments.
Inavolisib isa film-coated tablet which isto be administered orally.
Julian 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.
"Inavolisibcan 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,pharmacistor nurse.
This medicinal product is subject toadditionalmonitoring. 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 reactionsto 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
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The approval was granted on26/11/2025 toROCHE PRODUCTS LIMITED.
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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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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
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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 newscentre@mhra.gov.uk or call 020 3080 7651.
Disclaimer: Curated by HT Syndication.
