MHRA Approves Inavolisib for Advanced HR-Positive, HER2-Negative Breast Cancer
Key Insights
The UK's MHRA approved inavolisib (Itovebi) on November 26, 2025, for adults with HR-positive, HER2-negative breast cancer (search) that has returned during or after hormone therapy and spread to other body parts.
The oral film-coated tablet provides a new targeted treatment option for patients whose cancer shows specific genetic changes and helps delay disease progression.
Common side effects include high blood sugar, mouth inflammation, diarrhea, tiredness, and anemia, with the medicine subject to additional safety monitoring.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved inavolisib (Itovebi) on November 26, 2025, providing a new targeted treatment option for adults with advanced breast cancer (search). The drug is specifically licensed for patients with HR-positive, HER2-negative breast cancer (search) that has returned during or shortly after hormone therapy and has spread to other parts of the body.
Treatment Specifications and Administration
Inavolisib is available as an oral film-coated tablet, offering convenient administration for eligible patients. The treatment is restricted to patients whose cancer demonstrates specific genetic changes and is not suitable for those who have recently received certain other cancer treatments.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, emphasized the clinical significance of this approval: "The approval of inavolisib provides a new targeted treatment for people with advanced breast cancer (search) that has returned or spread after hormone therapy. Inavolisib can help delay the progression of the disease, giving patients more time with effective treatment."
Safety Profile and Monitoring
The most common side effects associated with inavolisib include high blood sugar, inflammation of the mouth (stomatitis), diarrhea, tiredness, anemia, nausea, decreased appetite, rash, headache, weight loss, vomiting, and urinary tract infections. A comprehensive list of side effects will be published in the Patient Information Leaflet and Summary of Product Characteristics on the MHRA website within seven days of approval.
The medicine is subject to additional monitoring to enable rapid identification of new safety information. Beach noted that "as with all licensed medicines, we will continue to monitor its safety and effectiveness closely as it becomes more widely used."
Regulatory and Safety Reporting
Patients experiencing side effects are encouraged to consult their doctor, pharmacist, or nurse. The MHRA emphasizes the importance of reporting suspected adverse reactions through the Yellow Card scheme, available via website or mobile app, to maintain continuous monitoring of the treatment's benefit-risk balance.
The approval was granted to Roche Products Limited, marking another advancement in expanding treatment options for people living with advanced breast cancer (search).