AUG 19 2026
Genentech — giredestrant $RHHBY
for ER-positive advanced breast cancer
About
ER-positive breast cancer is a common form of breast cancer that grows in response to the hormone estrogen and can spread to other parts of the body, causing symptoms like bone pain and fatigue. Giredestrant is an experimental drug that blocks estrogen receptors on cancer cells, preventing estrogen from fueling their growth. By cutting off this hormone signal, giredestrant may slow the progression of advanced ER-positive breast cancer in patients who have already tried other treatments.
Pivotal trial
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advance...
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on giredestrant
- FDA Accepts NDA for Roche’s Giredestrant in Early-Stage Breast Cancer - The Clinical Trial Vanguard
- FDA accepts New Drug Application for Roche’s giredestrant - GlobeNewswire
- FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting - BioSpace
- Giredestrant Plus Afinitor Delays Need For Chemotherapy in Breast Cancer - Cure Today
- Peter Schmid on ER Positive HER2 Negative Early Breast Cancer Giredestrant by Menopausal Status - The ASCO Post
Sponsor Watch — recent news on Genentech
- FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting
- FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting