FDA Accepts Giredestrant NDA Under Priority Review for Early ER+ Breast Cancer — Decision Due November 30

The U.S. Food and Drug Administration has accepted for review a New Drug Application (NDA) for giredestrant, Roche and Genentech’s investigational oral selective estrogen receptor degrader (SERD), as an adjuvant treatment for adults with estrogen receptor (ER)-positive, HER2-negative Stage I, II, or III breast cancer. The agency granted Priority Review, setting a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026. Giredestrant has not been approved.

The NDA is supported primarily by data from the Phase 3 lidERA Breast Cancer trial (NCT04961996), a global randomized study that enrolled 4,170 patients with medium- or high-risk early-stage ER+/HER2– breast cancer post-surgery. Patients received either 30 mg giredestrant orally once daily or physician’s choice of standard endocrine monotherapy (an aromatase inhibitor or tamoxifen) for at least five years.

The trial met its primary endpoint of invasive disease-free survival (IDFS). Giredestrant reduced the hazard of invasive disease recurrence or death by 30% relative to standard endocrine therapy (hazard ratio 0.70; 95% CI, 0.57–0.87; p = 0.0014). At three years, IDFS rates were 92.4% in the giredestrant arm versus 89.6% in the control arm — an absolute difference of approximately 2.8 percentage points. The benefit was consistent across both premenopausal (HR 0.65) and postmenopausal (HR 0.74) subgroups. Results were presented at the 2025 San Antonio Breast Cancer Symposium.

SERDs work by binding to the estrogen receptor and triggering its degradation, blocking the hormonal signaling that drives most ER+ tumors. Fulvestrant, the only currently approved SERD, is administered by intramuscular injection. Giredestrant would be the first oral SERD with positive Phase 3 data in the curative-intent (adjuvant) setting, a distinction Roche has highlighted in its regulatory filings.

If approved, giredestrant would compete with aromatase inhibitors — the current standard of care for adjuvant endocrine therapy — which are also orally administered. The key differentiation from AIs is the degrader mechanism; whether that translates to durable clinical benefit over a five-to-ten-year adjuvant course will be a central question for FDA reviewers.

Giredestrant is investigational and has not been approved by the FDA for any use. This article describes a regulatory filing, not an approved therapy.