AUG 19 2026
Genentech — giredestrant $RHHBY
for ER-positive advanced breast cancer
Accepted FEB 19 2026.
About
ER-positive advanced breast cancer is a form of the disease where tumor growth is fueled by the hormone estrogen. Giredestrant is an oral drug that blocks the estrogen receptor, which acts like a biological switch for cancer cells. By turning off this switch, the drug may help slow or stop the progression of the cancer.
Pivotal trial
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on giredestrant
- Roche Boasts Full Late-Stage Pipeline as it Awaits Key Giredestrant FDA Decisions - Precision Medicine Online
- Dr Mardones on Giredestrant Plus Palbociclib in Estrogen Receptor+ Breast Cancer - OncLive
- HR-Positive/HER2-Negative Early Breast Cancer: Emerging Endocrine Strategies and the Potential Role of Giredestrant - OncLive
- Giredestrant Plus Everolimus Shows Survival Benefits in Advanced Breast Cancer - Oncology News Central
- Giredestrant Receives FDA Priority Review for Early-Stage ER-Positive Breast Cancer - Pharmacy Times
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