MHRA approves Roche’s Itovebi for advanced breast cancer treatment

UK— The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Roche’s Itovebi (inavolisib) for treating adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.

This approval marks a significant development for patients whose cancer has progressed despite previous hormone therapy.

The medication targets patients whose cancer has returned during or shortly after hormone therapy and has spread to other parts of the body.

 Specifically, inavolisib is designed for individuals whose tumors display particular genetic alterations.

However, the treatment is not suitable for patients who have recently received certain other cancer therapies.

Healthcare providers will administer inavolisib as a film-coated tablet that patients take by mouth.

This oral formulation offers a more convenient delivery method compared to intravenous treatments.

The MHRA plans to publish detailed information about the medication, including a complete list of side effects, in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) on its website shortly.

Clinical data have identified several common side effects associated with inavolisib use.

These include elevated blood sugar levels, mouth inflammation (stomatitis), anaemia, diarrhoea, and persistent tiredness.

Additionally, patients may experience decreased appetite, nausea, headaches, skin rashes, weight loss, urinary tract infections, and vomiting.

The regulatory agency strongly advises patients who notice any potential side effects to reach out to their doctor, nurse, or pharmacist for guidance.

Regulators have placed inavolisib under additional monitoring protocols to enable swift identification of any new safety concerns.

This enhanced surveillance system allows healthcare professionals and patients to report suspected adverse reactions following authorization.

 Such reporting plays a crucial role in the ongoing assessment of the medicine’s benefits weighed against its risks.

Julian Beach, interim executive director for healthcare quality and access at MHRA, emphasized the importance of this approval.

 He explained that inavolisib offers a new targeted therapy option for people living with advanced breast cancer that has returned or metastasized after hormone treatment.

Beach noted that the medication can help slow disease progression, thereby extending the period during which patients receive effective treatment.

He also confirmed that MHRA will maintain close monitoring of the drug’s safety profile and effectiveness as more patients begin using it.

In a separate development earlier this year, MHRA approved GSK’s Blujepa (gepotidacin) in August 2025.

This oral antibiotic pill treats uncomplicated urinary tract infections in females aged 12 years and older who weigh at least 40 kilograms.