Giredestrant
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Genentech’s Giredestrant Moves Forward for ER+, ESR1-Mutated Advanced Breast Cancer Following FDA NDA Acceptance
The FDA has accepted Genentech’s New Drug Application for giredestrant, an oral SERD, for ER+/HER2- advanced breast cancer with ESR1 mutations. This investigational drug targets a key resistance mechanism, potentially offering a less toxic alternative to chemotherapy for approximately 40% of patients with this mutation. Data from the Phase III EMERALD trial will guide the FDA’s review, which could lead to a significant advancement in precision oncology.
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Giredestrant Improves Progression-Free Survival in ER-Positive Advanced Breast Cancer: Roche’s Phase III evERA Trial
Roche’s Phase III evERA trial showed promising results for giredestrant plus everolimus in ER-positive, HER2-negative advanced breast cancer after CDK4/6 inhibitor therapy. The combination significantly improved progression-free survival (PFS) compared to standard endocrine therapy plus everolimus. The PFS risk reduction was 44% in ITT and 62% in ESR1-mutated patients. While overall survival data is still maturing, a positive trend was observed. Giredestrant + everolimus could become a new standard of care.
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Giredestrant Significantly Improves Progression-Free Survival in ER-Positive Advanced Breast Cancer: Positive Phase III Results
Genentech’s Phase III evERA study demonstrated that giredestrant plus everolimus significantly improved progression-free survival (PFS) in ER-positive, HER2-negative advanced breast cancer patients who progressed after CDK4/6 inhibitor therapy, compared to standard-of-care plus everolimus. This benefit was seen in both ITT and ESR1-mutated populations. The all-oral combination was well-tolerated with no new safety signals. evERA is the first positive Phase III trial of an all-oral SERD-containing regimen. Data will be shared with health authorities.
