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.

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 br

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