Celcuity Inc. announced on September 30, 2026, that REVTORPYK (gedatolisib) is now commercially available in the United States for adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after at least one line of endocrine therapy in the metastatic setting. The FDA approved gedatolisib on July 14, 2026, in two regimens: in combination with palbociclib and fulvestrant (the triplet) and in combination with fulvestrant alone (the doublet).
In the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 trial, the gedatolisib triplet and doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared with fulvestrant. Detailed efficacy and safety data beyond these hazard ratio figures were not disclosed in the commercial availability announcement.
Key finding
In the PIK3CA wild-type cohort of VIKTORIA-1, the gedatolisib triplet (with palbociclib and fulvestrant) reduced the risk of disease progression or death by 76% versus fulvestrant, representing the primary clinical evidence supporting FDA approval.
Study Design
| Trial | Phase 3 VIKTORIA-1 |
|---|---|
| Population | Adult patients with HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation detected (PIK3CA wild-type cohort), following progression on or after at least one line of endocrine therapy in the metastatic setting |
| Treatment | Gedatolisib + palbociclib + fulvestrant (triplet) vs. gedatolisib + fulvestrant (doublet) vs. fulvestrant alone |
| Primary endpoint | Not specified in the source material |
| Key secondary endpoints | Not specified in the source material |
The VIKTORIA-1 trial included at least two cohorts: a PIK3CA wild-type cohort, which formed the basis of the approved indication, and a PIK3CA-mutated cohort (Study 2), for which Celcuity submitted a supplemental New Drug Application to the FDA in August 2026. Further details on trial design, stratification factors, and endpoints were not disclosed in the launch announcement.
Results and Safety
In the PIK3CA wild-type cohort of VIKTORIA-1, the gedatolisib triplet reduced the risk of disease progression or death by 76% compared with fulvestrant, and the gedatolisib doublet reduced that risk by 67% compared with fulvestrant. The company characterized these as “unprecedented clinical benefit,” though absolute progression-free survival rates, median follow-up duration, overall survival data, and objective response rates were not reported in the commercial availability announcement.
No safety or tolerability data were disclosed in this announcement. Prescribers are directed to the full prescribing information for a complete description of adverse events and warnings associated with gedatolisib.
Clinical Context
HR+/HER2- breast cancer is the most common breast cancer subtype, accounting for approximately 70% of all cases. While outcomes are generally favorable in early-stage disease, approximately 30% of patients diagnosed with or who progress to metastatic disease are expected to survive five years. Within this population, patients whose tumors lack a PIK3CA mutation represent a subgroup with historically limited targeted options in the second-line metastatic setting, as PI3K inhibitors previously approved in this space, such as alpelisib, are indicated specifically for PIK3CA-mutated disease.
Gedatolisib is described as the first and only FDA-approved therapy to inhibit all class I PI3K isoforms (α, β, δ, γ) as well as mTOR complexes mTORC1 and mTORC2, distinguishing its mechanism from more selective PI3K inhibitors. Celcuity is also developing gedatolisib for first-line HR+/HER2- advanced breast cancer and for second-line metastatic castration-resistant prostate cancer, and the pending supplemental NDA for PIK3CA-mutated breast cancer, if approved, would extend its eligible patient population regardless of PIK3CA tumor status.
Sources
- Celcuity Inc. “Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States.” Press release. September 30, 2026. View source.
AI disclosure: This article was prepared with assistance from generative AI using the source material cited above. It was reviewed and edited by Brandon Twyford before publication.
