Giredestrant NDA has been accepted by the U.S. Food and Drug Administration for review in patients with ESR1-mutated, ER-positive advanced breast cancer. Genentech, a member of the Roche Group, announced that the FDA accepted its New Drug Application for giredestrant in combination with everolimus.
The application covers adults with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer after progression on prior endocrine therapy. The FDA plans to decide on approval by December 18, 2026. If approved, this regimen could become the first oral selective estrogen receptor degrader (SERD) combination available in the post-CDK4/6 inhibitor setting.
Strong Phase III evERA Trial Results
The filing relies on results from the Phase III evERA Breast Cancer study. The trial showed that giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the intention-to-treat population. In the ESR1-mutated subgroup, the risk reduction reached 62% compared with standard endocrine therapy plus everolimus.
Median progression-free survival improved significantly. In the ESR1-mutated group, patients receiving the combination achieved 9.99 months of median PFS versus 5.45 months in the comparator arm. Similarly, in the overall population, median PFS reached 8.77 months versus 5.49 months.
Although overall survival data remain immature, researchers observed a positive trend in both populations. Importantly, the safety profile remained manageable and consistent with known effects of the individual therapies. Investigators reported no unexpected safety findings.
Addressing Endocrine Resistance in ER-Positive Breast Cancer
ER-positive breast cancer represents nearly 70% of all breast cancer cases. However, resistance to endocrine therapy—especially after CDK4/6 inhibitors—remains a major challenge. As a result, many patients face disease progression and limited treatment options.
The giredestrant combination targets two signaling pathways while maintaining an oral treatment approach. Therefore, it may offer a convenient and effective option without the need for injections.
Expanding the Giredestrant Development Program
The evERA trial marks the first positive Phase III readout for giredestrant. In addition, the Phase III lidERA study in early-stage breast cancer has reported positive results. Earlier data from the coopERA trial showed that giredestrant reduced Ki67 levels more effectively than an aromatase inhibitor in the neoadjuvant setting.
Furthermore, the persevERA readout in first-line ER-positive breast cancer is expected soon. Together, these studies strengthen the scientific foundation for giredestrant across multiple treatment stages.
Genentech continues to advance its global development program to bring innovative endocrine therapies to patients with ER-positive breast cancer.
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