US FDA Accepts NDA for Genentech's Giredestrant in ER-Positive Early-Stage Breast Cancer
The US FDA has accepted Genentech’s New Drug Application (NDA) for giredestrant, an investigational oral SERD for ER-positive early-stage breast cancer. Supported by positive phase 3 trial results, giredestrant is the first and only oral SERD to demonstrate efficacy in the curative setting.
Giredestrant | 03/06/2026 | By News Bureau
Roche Reports Update on PERSEVERA Breast Cancer Trial
Roche reported that the Phase III persevERA study in ER-positive advanced breast cancer did not meet its primary endpoint, though giredestrant plus palbociclib showed numerical improvement and a tolerable safety profile.
Giredestrant | 09/03/2026 | By News Bureau | 109
Roche Reports Positive Results from Phase III evERA Breast Cancer Study
Roche has announced positive results from the phase III evERA study evaluating its investigational oral selective oestrogen receptor degrader (SERD), giredestrant, in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
Giredestrant | 24/09/2025 | By Dineshwori | 183
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