MHRA gives approval to Roche Products’ inavolisib for treating breast cancer

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has officially authorized Roche Products inavolisib (Itovebi) for the treatment of adults diagnosed with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.

This approval allows inavolisib to be prescribed for patients whose cancer has returned during or shortly after hormone therapy and has spread to other parts of the body. The medication is intended for patients whose cancer exhibits specific genetic alterations and is not suitable for those who have recently undergone certain other cancer treatments.

The approved form of inavolisib is an oral, film-coated tablet. A detailed list of potential side effects will be made available in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) on the MHRA website shortly after approval. Common side effects include elevated blood sugar, mouth inflammation (stomatitis), anemia, diarrhea, fatigue, reduced appetite, nausea, headache, rash, weight loss, urinary tract infections, and vomiting. Patients experiencing side effects should seek guidance from a doctor, nurse, or pharmacist.

Inavolisib will be under additional monitoring to quickly identify any new safety information. Reporting any suspected adverse reactions after authorization is crucial for ongoing evaluation of the drugs benefit-risk profile.

Julian Beach, interim executive director for healthcare quality and access at MHRA, commented: The approval of inavolisib introduces a targeted therapy for individuals with advanced breast cancer that has returned or spread following hormone therapy. It can help slow disease progression, providing patients with more time on effective treatment. As with all licensed medications, we will continue to closely monitor its safety and effectiveness as it becomes more widely used.

Author: Sophia Brooks