Genentech recently announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review (PR) for giredestrant, an investigational oral Selective Estrogen Receptor Degrader (SERD), as an adjuvant treatment for adults with Estrogen Receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage 1, 2 and 3 breast cancer. The FDA is expected to make a decision on the approval by November 30, 2026.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head, Global Product Development, said, “Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest. 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 acceptance is based on the phase 3 lidERA breast cancer study results, which showed adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death (iDFS) by 30 percent compared with Standard-of-Care Endocrine Therapy (SoC ET) (hazard ratio [HR]=0.70, 95 percent confidence interval [CI]: 0.57-0.87, p=0.0014). At 3 years, 92.4 percent of patients in the giredestrant arm were alive and free of invasive disease versus 89.6 percent in the SoC ET arm.

The iDFS benefit was consistent across all clinically relevant subgroups. Overall Survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed. Follow-up for OS will continue to the next analysis. Giredestrant was well tolerated; Adverse Events (AEs) were manageable and consistent with its known safety profile. The treatment discontinuation rate for giredestrant was 5.3 percent versus 8.2 percent with SoC ET.

Additional analyses from the giredestrant program were presented at the 2026 American Society of Clinical Oncology (ASCO) Congress. This growing body of evidence continues to reinforce the clinical benefit profile of giredestrant and its potential to meaningfully improve outcomes across ER-positive early-stage and advanced breast cancer.

The FDA recently accepted the NDA for giredestrant in combination with everolimus for those with ESR1-mutated, ER-positive advanced breast cancer based on the evERA results, with a decision expected in December 2026.

Genentech’s expanding giredestrant clinical development program spans distinct treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.