New Treatment for Advanced Breast Cancer Approved by MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for inavolisib, marketed as Itovebi, to be used among adults with HR-positive, HER2-negative breast cancer. This new drug is specifically intended for patients whose cancer has recurred during or shortly after hormone therapy and has metastasised to other areas of the body.
Details of the Approval
As of 26 November 2025, inavolisib will be available to patients exhibiting specific genetic alterations associated with their breast cancer. However, it is not suitable for individuals who have recently undergone certain other cancer treatments. The medication is formulated as a film-coated tablet that is taken orally.
Expert Commentary
Julian Beach, the Interim Executive Director of Healthcare Quality and Access at the MHRA, commented on the significance of this approval, stating that it offers a new targeted option for patients grappling with advanced stages of breast cancer. He highlighted how inavolisib may assist in delaying disease progression, providing patients with more time to benefit from effective therapies.
Beach reassured the public that, as with any newly licensed medication, ongoing scrutiny will be applied to ensure its safety and efficacy as it becomes more widely prescribed.
Side Effects and Monitoring
A comprehensive list of potential side effects will be made available in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC), which are expected to be accessible on the MHRA’s website within one week of this announcement. Common side effects include elevated blood sugar levels, inflammation of the mouth, diarrhea, fatigue, anaemia, nausea, loss of appetite, rash, headaches, weight loss, vomiting, and urinary tract infections.
Patients experiencing any adverse effects related to inavolisib are encouraged to consult their healthcare providers, including doctors, pharmacists, or nurses.
Ongoing Safety Monitoring
This drug will be subjected to enhanced monitoring to facilitate the quick identification of new safety information. Reporting any suspected adverse reactions post-approval is crucial for the continual assessment of the balance between benefits and risks associated with inavolisib. Concerns can be reported through the MHRA Yellow Card scheme, available online or via various app stores.
Background
This approval marks a significant advancement in the battle against advanced breast cancer, a condition that frequently poses treatment challenges. The MHRA’s endorsement of inavolisib supports the ongoing efforts to provide innovative therapies for patients facing complex treatment scenarios.
Source: official statements, news agencies, and public reports.
https://www.gov.uk/government/news/mhra-approves-inavolisib-for-the-treatment-of-breast-cancer
