Also known as: GDC-9545
Giredestrant is a next-generation oral selective estrogen receptor degrader (SERD) and full estrogen receptor antagonist being developed by Genentech. Its development focus includes ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer. It is currently in development and not FDA approved.
Roche's giredestrant plus palbociclib missed its primary endpoint in a phase 3 breast cancer trial. Numerical improvement was seen without statistical significance. Shares fell sharply; a second readout is due in 2027.
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
Roche Holding AG shares show potential undervaluation despite strong returns, with DCF models suggesting 59% upside. The pharmaceutical giant trades at P/E ratios below fair value estimates while maintaining solid financial performance and dividend growth. Recent pipeline developments and product innovations support long-term growth prospects.
Roche's experimental breast cancer pill giredestrant combined with a CDK4/6 inhibitor failed to meet its primary endpoint in a Phase III trial for first-line treatment of ER-positive, HER2-negative advanced breast cancer, marking a setback for the drugmaker's next-generation hormone therapy program.
The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07643831 |
Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced/Metastatic Breast Cancer |
AVAILABLE | |
| NCT07541079 |
A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer) |
RECRUITING | PHASE3 |
| NCT07214662 |
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer |
TERMINATED | PHASE1 |
| NCT07100106 |
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT06065748 |
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) |
RECRUITING | PHASE3 |
| NCT05896566 |
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer |
COMPLETED | PHASE2 |
| NCT05708235 |
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population |
RECRUITING | PHASE2 |
| NCT05659563 |
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% |
COMPLETED | PHASE2 |
| NCT05634499 |
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05306340 |
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) |
ACTIVE_NOT_RECRUITING | PHASE3 |
