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NOV 30 2026
UPCOMING · 62 DAYS TO PDUFA

Genentech — giredestrant $RHHBY

for adjuvant treatment of ER-positive, HER2-negative, stage I-III breast cancer

NDA · Priority Review

Accepted JUN 2 2026.

About

Breast cancer begins in the breast tissue and can show up as a lump, a change in breast shape, or skin dimpling, and it becomes far more dangerous once it spreads to distant organs. Giredestrant is an oral drug that binds to the estrogen receptor inside breast cancer cells and blocks estrogen from fueling their growth. Because this cancer depends on estrogen to grow, shutting off that signal may help keep the disease from returning after surgery.

Pivotal trial

kalitERA Phase 3 not yet recruiting NCT07827573

The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant. The study will have two cohorts

Source: ClinicalTrials.gov

Also in development