Celcuity Initiates NDA Submission for Gedatolisib in PIK3CA Wild-Type HR+/HER2- Advanced Breast Cancer Under FDA's RTOR Program.

Celcuity is initiating a New Drug Application for gedatolisib in HR+/HER2- advanced breast cancer under the FDA's Real-Time Oncology Review program. The submission is based on positive topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Gedatolisib reduced the risk of disease progression or death by 76% and 67% compared to fulvestrant in the gedatolisib-triplet and gedatolisib-doublet arms, respectively. Completion of the NDA submission is targeted for Q4 2025.

Celcuity Inc. (NASDAQ: CELC) 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 demonstrating substantial improvements over existing therapies, expediting the review process and potentially bringing gedatolisib to market sooner than through standard channels. The clinical data supporting this application is remarkably strong, with hazard ratios representing some of the most substantial improvements ever seen in HR+/HER2- advanced breast cancer trials [1].

Celcuity's announcement represents a significant regulatory milestone for gedatolisib in HR+/HER2- advanced breast cancer treatment. 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