Pharma Focus Asia

Roche Introduced Inavolisib for the Treatment of HER2-negative Breast Cancer

Roche has introduced inavolisib, an oral investigational therapy, combined with palbociclib (Ibrance®) and fulvestrant, for treating adult patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced, or metastatic breast cancer, following recurrence within 12 months of completing adjuvant endocrine treatment.

This inavolisib-based regimen shows promise in potentially reshaping the landscape of PI3K inhibitor therapies, potentially setting a new standard of care for this patient group in the frontline setting.

Inavolisib, an investigational oral targeted therapy, holds the promise of being best-in-class, offering potentially well-tolerated, long-lasting disease management and potentially improved outcomes for individuals with PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced, or metastatic breast cancer, a population often facing a challenging prognosis and a pressing need for new treatment avenues.

Designed to reduce the overall treatment burden and toxicity, inavolisib stands out among PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform, along with its distinct mechanism of action facilitating mutated PI3K alpha degradation.

PIK3CA mutations are frequently observed in advanced or metastatic breast cancer cases. Despite this prevalence, many patients undergo PIK3CA testing later in their treatment journey. Early testing for PIK3CA mutations before initiating first-line treatment aids clinicians in making personalised treatment decisions.

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for inavolisib, an investigational oral therapy, in the treatment of advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.


magazine-slider-imageHexagon - Expert Insights WebinarMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference