Roche has said that the US FDA has accepted its New Drug Application (NDA) for giredestrant under Priority Review, putting the investigational breast cancer therapy on a regulatory fast track in early-stage disease.
The application covers giredestrant—an oral selective oestrogen receptor degrader (SERD)—as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, HER2-negative stage I–III breast cancer. The FDA is expected to issue a decision by 30 November 2026.
“Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
“The FDA’s filing acceptance brings us closer to delivering a new standard-of-care with the potential to fundamentally change the treatment paradigm for people with early-stage disease.”
The filing is backed by Phase III data from the lidERA Breast Cancer study, which enrolled more than 4,100 patients and compared giredestrant against standard endocrine therapy.
The trial showed a 30% reduction in the risk of invasive disease recurrence or death, with a hazard ratio of 0.70. At three years, 92.4% of patients receiving giredestrant remained alive and free of invasive disease versus 89.6% on standard care. Overall survival data remain immature, though a positive trend has been observed.
Safety results were consistent with earlier findings, with manageable adverse events and lower discontinuation rates—5.3% for giredestrant compared with 8.2% for standard therapy.
“Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
“The FDA’s filing acceptance brings us closer to delivering a new standard-of-care with the potential to fundamentally change the treatment paradigm for people with early-stage disease.”
