MHRA approves Roche’s Itovebi for breast cancer

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday approved Swiss pharma giant Roche’s (ROG: SIX) Itovebi (inavolisib (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.

In July this year, the European Commission approved Itovebi, in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The US Food and Drug Administration (FDA) approved Itovebi in the same indication in October last year.