FDA Approves Gedatolisib in Breast Cancer - Report - MDSpire

FDA Approves Gedatolisib in Breast Cancer

In VIKTORIA-1, gedatolisib-containing regimens resulted in longer median progression-free survival than fulvestrant alone.

  • By

  • Kathryn Wighton

  • July 14, 2026

  • 2 min

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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

RegimenMedian PFS (months)Objective Response Rate (%)
Gedatolisib + Fulvestrant + Palbociclib9.332
Gedatolisib + Fulvestrant7.428
Fulvestrant Alone2.01

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

Original Source(s)

FDA Approves Gedatolisib in Breast Cancer

  • by Kathryn Wighton

  • July 14, 2026

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