Roche Holding AG (RHHBY), a healthcare company, reported that its New Drug Application seeking approval for Giredestrant as an adjuvant treatment for patients with stage I-III ER+/HER- breast cancer has been accepted for priority review by the FDA.
The U.S. regulatory agency's decision on Giredestrant, an oral selective oestrogen receptor degrader, is expected on November 30, 2026.
Globally, every year 2.3 million women are diagnosed with breast cancer, of which 70% of the cases are attributed to ER-positive breast cancer diagnosed in their early stage.
Despite treatment advancements, the risk of side effects and resistance to endocrine therapy is a significant limitation.
To address these challenges, Giredestrant is being evaluated as a better and tolerated treatment option to prevent disease recurrence. It is designed to block oestrogen from binding to its receptor leading to oestrogen degradation which in turn slows down the growth of cancer cells.
The New Drug Application for Giredestrant was accepted based on results from a phase III trial, dubbed lidERA.
lidERA is a phase III, randomised, open-label study which evaluated giredestrant as an adjuvant treatment against current standard-of-care endocrine therapy for people with medium or high-risk stage I-III oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The study enrolled 4,100 patients.
The primary endpoint for the study was invasive disease-free survival or iDFS, with an exclusion criterion of unrelated cancers in other organs (second primary non-breast cancers).
According to study results, Giredestrant as an adjuvant significantly reduced the risk of iDFS by 30% compared to standard-of-care endocrine therapy or SoC ET. At three years, 92.4% of patients in the giredestrant arm were alive and free of iDFS versus 89.6% in the SoC ET arm. The treatment discontinuation rate for giredestrant was 5.3% compared to 8.2% with SoC ET.
Another NDA for giredestrant in combination with everolimus for those with ESR1-mutated, ER-positive advanced breast cancer was recently accepted by the FDA, with a decision anticipated in December 2026.
RHHBY closed Monday's trading at $50.22, down 4.16%.
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