FDA Approves Real-Time Oncology Review of Celcuity's Gedatolisib for Advanced Breast Cancer

Celcuity will initiate NDA submission for gedatolisib under the FDA's Real-Time Oncology Review program. The submission will begin in September 2025 and is expected to complete in Q4 2025. The Phase 3 VIKTORIA-1 trial showed that gedatolisib-triplet therapy reduced disease progression risk by 76% in PIK3CA wild-type HR+/HER2- advanced breast cancer. Gedatolisib has received Breakthrough Therapy and Fast Track designations and is expected to expedite its development and approval.

Minneapolis, Aug. 27, 2025 (GLOBE NEWSWIRE) — Celcuity Inc. (NASDAQ: CELC), a clinical-stage biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for gedatolisib in HR+/HER2- advanced breast cancer under the Real-Time Oncology Review (RTOR) program. The company plans to initiate a rolling submission in September 2025, with completion targeted for Q4 2025.

The submission is based on groundbreaking Phase 3 VIKTORIA-1 trial results, where the gedatolisib-triplet therapy reduced disease progression risk by 76% compared to fulvestrant alone, with a median progression-free survival (PFS) of 9.3 vs. 2.0 months. The gedatolisib-doublet showed a 67% risk reduction with a median PFS of 7.4 vs. 2.0 months. These results represent unprecedented improvements in HR+/HER2- advanced breast cancer treatment [1].

The FDA's acceptance of Celcuity's NDA under the RTOR program is significant. This pathway is reserved for drugs showing substantial improvements over existing therapies, enabling an expedited review process. This could potentially bring gedatolisib to market sooner than through standard channels [1].

The clinical data supporting this application is remarkably strong. The Phase 3 VIKTORIA-1 trial results in the PIK3CA wild-type cohort demonstrated unprecedented efficacy: the gedatolisib-triplet (combined with fulvestrant and palbociclib) reduced disease progression or death risk by 76% (hazard ratio: 0.24), and the median PFS improved from 2.0 months with fulvestrant alone to 9.3 months with the triplet regimen. Even the gedatolisib-doublet (with fulvestrant) showed impressive results with a 67% risk reduction (hazard ratio: 0.33) and a median PFS of 7.4 months [1].

These hazard ratios represent some of the most substantial improvements ever seen in HR+/HER2- advanced breast cancer trials. For context, most successful trials in this space typically show hazard ratios in the 0.5-0.7 range, making gedatolisib's 0.24 truly exceptional [1].

The drug's earlier Breakthrough Therapy and Fast Track designations further underscore its potential significance. For patients with HR+/HER2- advanced breast cancer who have progressed after CDK4/6 inhibitor treatment, therapeutic options remain limited, highlighting the unmet medical need gedatolisib addresses [1].

With submission initiation in September and completion targeted for Q4 2025, Celcuity is positioning gedatolisib for potential approval in 2026, assuming standard FDA review timelines following a complete submission [1].

References:
[1] https://www.stocktitan.net/news/CELC/celcuity-to-initiate-nda-submission-of-gedatolisib-in-pik3ca-wild-u9uvrrmp5z07.html