The FDA has officially accepted a new drug application for gedatolisib to treat specific types of advanced breast cancer, marking an important step toward making this new therapy available for patients.
What Is Gedatolisib Being Considered For?
Gedatolisib is being reviewed for patients with PIK3CA wild-type hormone receptor–positive/HER2-negative advanced breast cancer who have already received treatment with a CDK4/6 inhibitor. The medication previously received both breakthrough therapy and fast track designations, thanks to promising early trial data.
How Well Did Gedatolisib Work in Studies?
Results from the phase 3 VIKTORIA-1 trial showed that the combination of gedatolisib, fulvestrant, and palbociclib reduced the risk of disease progression or death by 76% compared to fulvestrant alone. Patients lived a median of 9.3 months without disease progression on this new combination, compared to just 2.0 months with standard therapy—a difference of over seven months.
What Happens Next?
The application is part of the FDA’s Real-Time Oncology Review program, meaning it’s being considered faster than usual. Developers plan to complete the submission by the end of 2025 based on this successful trial, and the FDA will review whether gedatolisib can become a new option for eligible breast cancer patients soon.
Who Can Participate in This Kind of Treatment?
Patients in the VIKTORIA-1 trial had metastatic or locally advanced breast cancer that was ER-positive and HER2-negative, and had experienced disease progression after previous standard therapies. Not everyone qualifies; for example, those with certain other cancers or who have been treated with similar drugs before were excluded from trial enrollment.
More Reading
Endocrine-Hormone Therapy for Advanced-Metastatic Breast Cancer
References
- Celcuity to initiate NDA submission of gedatolisib in PIK3CA wild-type cohort in HR+/HER2- advanced breast cancer under FDA’s Real-Time Oncology Review Program. News release. Celcuity Inc. August 28, 2025. Accessed August 29, 2025. https://tinyurl.com/5ca5u96u
- Gedatolisib plus fulvestrant with or without palbociclib vs standard-of-care for the treatment of patients with advanced or metastatic HR+/HER2- breast cancer (VIKTORIA-1) (VIKTORIA-1). ClinicalTrials.gov. Updated June 24, 2025. Accessed August 28, 2025. https://tinyurl.com/yc3jmmy5
