The Medicines and Healthcare products Regulatory Agency has approved inavolisib (Itovebi) for the treatment of adults with HR-positive, HER2-negative breast cancer that has returned during or shortly after hormone therapy and spread to other parts of the body.
The treatment is licensed for patients whose cancer shows specific genetic changes and is not suitable for those who have recently received certain other cancer treatments.
Inavolisib is an oral film-coated tablet, offering a convenient administration route for eligible patients.
A full list of side effects will be published on the MHRA website within seven days in the Patient Information Leaflet and Summary of Product Characteristics.
Common side effects can include:
- High blood sugar
- Mouth inflammation (stomatitis)
- Diarrhoea
- Tiredness
- Anaemia
- Nausea and decreased appetite
- Rash, headache, weight loss
- Vomiting and urinary tract infections
Interim Executive Direcor of Health Quality and Access at the MHRA, Julian Beach, commented:
“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.”
Patients experiencing side effects should speak to their doctor, pharmacist, or nurse.
This medicine is subject to additional monitoring to ensure rapid identification of new safety information. Reporting suspected adverse reactions is vital to maintain the benefit-risk balance of the treatment.
The approval of inavolisib marks another step forward in expanding treatment options for people living with advanced breast cancer.
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