Clinical Report: FDA Approves Gedatolisib in Breast Cancer

Overview

The FDA has approved gedatolisib in combination with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative breast cancer lacking a PIK3CA mutation. The approval is based on improvements in progression-free survival compared to fulvestrant alone.

Background

Breast cancer remains a leading cause of cancer-related morbidity and mortality, particularly in hormone receptor-positive subtypes. The approval of new therapeutic agents like gedatolisib addresses the need for effective treatment options in patients who have progressed on prior endocrine therapy.

Data Highlights

Key Findings

• Gedatolisib, when combined with fulvestrant and palbociclib, resulted in a median progression-free survival of 9.3 months.
• Patients receiving gedatolisib with fulvestrant alone had a median progression-free survival of 7.4 months.
• Fulvestrant alone showed a median progression-free survival of only 2.0 months.
• Objective response rates were 32% for the triplet regimen, 28% for the doublet, and 1% for fulvestrant alone.
• Warnings for gedatolisib include stomatitis, dermatologic reactions, hyperglycemia, and embryo-fetal toxicity.
• The recommended dosage is 180 mg administered as a 30-minute IV infusion once weekly.

Clinical Implications

Monitoring for potential adverse effects, including stomatitis and hyperglycemia, is essential during treatment.

Conclusion

The approval of gedatolisib offers improved progression-free survival for patients with specific disease characteristics.

Related Resources & Content

1. US Food and Drug Administration, FDA, 2026 -- FDA Approves Gedatolisib in Breast Cancer
2. Hurvitz et al, Journal of Clinical Oncology, 2026 -- VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant
3. The ASCO Post — Gedatolisib-Based Regimens in HR-Positive, HER2-Negative, PIK3CA Wild-Type Advanced Breast Cancer
4. the asco post — FDA Approves Taletrectinib for ROS1-Positive Non–Small Cell Lung Cancer
5. The ASCO Post — FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018
6. The ASCO Post — FDA Grants Regular Approval to Sacituzumab Govitecan-hziy for Pretreated Patients With Triple-Negative Breast Cancer
7. Gedatolisib Combinations Approved by FDA for HR-Positive/HER2-Negative Breast Cancer
8. VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor–Positive/HER2−/PIK3CA Wild-Type Advanced Breast Cancer
9. A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant (MT) advanced breast cancer (VIKTORIA-1 Study 2). | Journal of Clinical Oncology