The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new targeted drug for returning breast cancer in women. 

Inavolisib (Itovebi) is for adults with HR-positive, HER2-negative breast cancer, and the approval marks a significant step forward in the treatment of advanced disease. 

The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy and has spread to other parts of the body. It is specifically for patients whose tumours carry certain genetic changes and is not suitable for those who have recently undergone particular other cancer treatments. 

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. 

“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.” 

Common side effects include high blood sugar, mouth inflammation (stomatitis), diarrhoea, tiredness, anaemia, nausea, decreased appetite, rash, headache, weight loss, vomiting, and urinary tract infections.

Patients experiencing side effects are urged to speak to their doctor, pharmacist, or nurse. Inavolisib is under additional monitoring to quickly identify any new safety information, and suspected adverse reactions should be reported through the MHRA Yellow Card scheme online or via its mobile app.