MINNEAPOLIS, Minn., July 14, 2026
Celcuity Inc. has achieved a major regulatory milestone after the U.S. Food and Drug Administration (FDA) approved REVTORPYK™ (gedatolisib) for the treatment of adults with hormone receptor-positive (HR+), HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy in the metastatic setting. The approval introduces the first and only FDA-approved therapy that simultaneously inhibits all Class I PI3K isoforms (α, β, δ, γ) together with both mTORC1 and mTORC2, providing a novel approach to targeting the PI3K/AKT/mTOR (PAM) signaling pathway, one of the most important drivers of breast cancer progression. The decision is supported by compelling Phase III VIKTORIA-1 clinical trial results, where REVTORPYK, administered with fulvestrant and with or without palbociclib, significantly reduced the risk of disease progression or death compared with fulvestrant alone while demonstrating clinically meaningful improvements in progression-free survival. Celcuity plans to commercially launch REVTORPYK in late Q3 2026 while simultaneously expanding patient access through an expanded access program prior to full commercial availability.
Phase III VIKTORIA-1 Trial Delivers Landmark Clinical Results
The FDA approval is based on data from the global Phase III VIKTORIA-1 study evaluating REVTORPYK plus fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer whose disease had progressed after CDK4/6 inhibitor therapy and aromatase inhibitor treatment. Clinical results demonstrated that the REVTORPYK triplet regimen reduced the risk of disease progression or death by 76%, while the doublet regimen lowered the risk by 67%, compared with fulvestrant alone. Patients receiving the triplet therapy achieved a median progression-free survival (PFS) of 9.3 months, compared with 2.0 months for the control arm, representing a substantial improvement in disease control. Objective response rates also increased significantly, with durable responses lasting up to 17.5 months in the triplet treatment group. These findings establish REVTORPYK as a significant advancement for patients with PIK3CA wild-type breast cancer, a population representing approximately 60% of HR+/HER2- breast cancer cases and one that has historically faced limited targeted treatment options.
Novel PI3K and mTOR Inhibition Addresses Unmet Clinical Need
Unlike currently available therapies that selectively target individual components of the PI3K signaling pathway, REVTORPYK (gedatolisib) delivers comprehensive blockade of all Class I PI3K isoforms together with both mTOR complexes, creating a broader inhibition of the cancer-driving PAM pathway. Researchers believe this unique mechanism may overcome resistance mechanisms that have limited the effectiveness of previous targeted therapies. HR+/HER2- breast cancer remains the most common subtype of breast cancer, accounting for approximately 70% of all breast cancer diagnoses, while the majority of patients within this subgroup possess PIK3CA wild-type disease. The approval therefore fills a significant therapeutic gap by providing a targeted treatment specifically designed for patients lacking PIK3CA mutations, many of whom previously had fewer precision medicine options after endocrine therapy failure. Celcuity also announced plans to submit a supplemental New Drug Application (sNDA) during Q3 2026 seeking expanded approval for patients with PIK3CA-mutated HR+/HER2- breast cancer, based on additional positive Phase III clinical findings.
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FDA Approval Strengthens Celcuity’s Precision Oncology Portfolio
The approval of REVTORPYK marks the first commercial product for Celcuity and significantly strengthens the company’s position in precision oncology. In addition to ongoing commercialization efforts, the company continues advancing VIKTORIA-2, a global Phase III clinical trial evaluating gedatolisib in first-line treatment settings, alongside a Phase 1/2 study investigating the therapy for metastatic castration-resistant prostate cancer. By successfully bringing the first FDA-approved pan-PI3K and mTORC1/2 inhibitor to market, Celcuity has established a new therapeutic option for patients with advanced breast cancer while reinforcing the importance of targeting multiple signaling pathways simultaneously. As precision medicine continues reshaping oncology treatment, REVTORPYK has the potential to improve clinical outcomes for thousands of patients worldwide and expand the role of targeted therapies in difficult-to-treat metastatic breast cancer.
Source: Celcuity press release
