The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Roche Products’ inavolisib (Itovebi) to treat adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
The approval enables the use of inavolisib in patients whose cancer has recurred during or shortly after hormone therapy and has metastasised to other areas of the body.
Inavolisib is indicated for those whose cancer shows specific genetic changes and is not appropriate for patients who have received certain other cancer treatments in the recent past.
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The approved formulation is a film-coated tablet to be taken orally.
A comprehensive list of side effects will be published in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) on the MHRA website shortly after approval.
Common side effects include high blood sugar, inflammation of the mouth (stomatitis), anaemia, diarrhoea, tiredness, decreased appetite, nausea, headache, rash, weight loss, urinary tract infections and vomiting.
Patients experiencing potential side effects are advised to consult a doctor, nurse or pharmacist.
Inavolisib is subject to additional monitoring, allowing rapid identification of new safety information. Reporting suspected adverse reactions post-authorisation is essential for ongoing evaluation of the medicine’s benefit/risk balance.
MHRA healthcare quality and access interim executive director Julian Beach stated: “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.”
In August 2025, MHRA granted approval to GSK’s oral antibiotic pill, Blujepa (gepotidacin), for uncomplicated urinary tract infections in females aged 12 and above with a minimum body weight of 40kg.
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