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Global biotechnology firm Roche has today announced that its brand of inavolisib (Itovebi) has gained an important approval from the US Food and Drug Administration (FDA).

The drug has been approved for the treatment of adult patients with advanced, endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor two (HER2)-negative breast cancer.

The FDA has authorized Itovebi as a combination therapy with palbociclib and fulvestrant in treatment of the cancer either after adjuvant endocrine therapy has been completed or following recurrence of the cancer.

Around 70% of breast cancer cases are HR-positive, making it the most prevalent form of the malignancy.

The presence of receptors in the tumor cells of HR-positive breast cancer that bind to either progesterone or estrogen can promote the tumor's growth.

Therefore, there’s need for additional treatment choices for people with HR-positive metastatic breast cancer since they are at a high risk of the illness progressing.

The approval is based on results from a phase III clinical trial coded INAVO120 that showed the inavolisib-based combination had superior efficacy when compared to palbociclib-fulvestrant only therapy.

These results earned the inavolisib-based regimen FDA Priority Review and Breakthrough Therapy Designation in May 2024.

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The study, sponsored by Roche, is a multicenter, randomized, double-blind, placebo-controlled trial that recruited 325 patients with HR-positive, HER2-negative, endocrine-resistant, PIK3CA-mutated, locally advanced or metastatic breast cancer whose disease progressed during or within a year after finishing adjuvant endocrine therapy and who had not previously received systemic therapy for locally advanced or metastatic disease.

At the time of the analysis, data demonstrated that the inavolisib-based therapy decreased the risk of disease progression or death by 57% compared to the palbociclib-fulvestrant-only regimen.

Roche’s Head of Global Product Development, Levi Garraway, emphasized the significance of the trial results and the FDA's approval, stating that treatment options for HR-positive breast cancer with the PIK3CA mutation remain limited despite the high prevalence of the disease.

According to the FDA, inavolisib should be taken as a daily oral dose of 9 mg up until disease progression is observed or unacceptable toxicity levels are reached.

Typical adverse reactions that should be monitored include nausea, headache, decreased appetite, elevated fasting glucose, and more.

Roche anticipates Itovebi will be available in the US market in the next few weeks while targeting to seek approvals from global regulatory authorities, including the European Medicines Agency.

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