BASEL, Switzerland, June 2, 2026
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), for the adjuvant treatment of adults with ER-positive, HER2-negative stage I-III breast cancer. The application has been granted Priority Review, with the FDA assigning a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026. If approved, giredestrant could become the first oral SERD available for patients in the curative early-stage breast cancer setting and represent the most significant advance in adjuvant endocrine therapy in more than two decades.
Phase III lidERA Trial Demonstrated Significant Reduction in Recurrence Risk
Roche’s NDA submission is supported by positive results from the Phase III lidERA Breast Cancer study, which enrolled more than 4,100 patients with medium- or high-risk ER-positive, HER2-negative early-stage breast cancer. The trial demonstrated that adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. At three years, 92.4% of patients treated with giredestrant remained alive and free of invasive disease, compared with 89.6% of patients receiving current standard endocrine therapies. The benefit was consistent across all clinically relevant patient subgroups, reinforcing the potential of giredestrant as a future standard treatment option.
Favorable Safety Profile Supports Potential New Standard of Care
Giredestrant was generally well tolerated throughout the Phase III study, with adverse events remaining manageable and consistent with its established safety profile. Treatment discontinuation due to adverse events occurred in 5.3% of patients receiving giredestrant, compared with 8.2% in the standard-of-care arm, suggesting improved treatment adherence may be possible. While overall survival data remain immature, investigators reported a positive trend favoring giredestrant, with additional follow-up ongoing. The favorable efficacy and tolerability profile strengthens the therapy’s potential to address persistent challenges associated with long-term endocrine treatment in early-stage breast cancer.
Advertisement
Expanding Development Program Targets Broad ER-Positive Breast Cancer Population
Roche continues to advance an extensive clinical development program for giredestrant across multiple breast cancer settings. In addition to the early-stage indication under review, the FDA recently accepted a separate NDA evaluating giredestrant in combination with everolimus for ESR1-mutated ER-positive advanced breast cancer, with a regulatory decision expected in December 2026. The company is currently evaluating giredestrant in five Phase III studies spanning early-stage, metastatic, endocrine-sensitive, endocrine-resistant, and HER2-positive breast cancer populations. With ER-positive disease accounting for approximately 70% of all breast cancer cases worldwide, Roche believes giredestrant has the potential to significantly improve outcomes and reduce recurrence risk for a large patient population.
Source: Roche press release
