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DEC 18 2026
UPCOMING · 80 DAYS TO PDUFA

Genentech — giredestrant $RHHBY

for ER-positive advanced breast cancer

NDA · Standard Review

Accepted FEB 20 2026.

About

Breast cancer begins in breast tissue and can cause a lump, skin changes, or nipple discharge, and it becomes far more serious when it spreads to bones, lymph nodes, or other organs. Giredestrant is an oral drug that binds to the estrogen receptor and blocks estrogen from fueling cancer cell growth. Because this cancer depends on estrogen to grow, blocking that receptor may help slow or stop the disease from worsening.

Pivotal trial

NCT06065748 Phase 3 active not recruiting NCT06065748

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Source: ClinicalTrials.gov

Also in development