Celcuity Receives FDA Approval For REVTORPYK To Treat Advanced HR+/HER2- Breast Cancer

Celcuity Inc., a biotechnology company focused on developing targeted therapies for solid tumors, has announced that the U.S. Food and Drug Administration (FDA) has approved REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor-positive (HR+), HER2-negative (HER2-) locally advanced or metastatic breast cancer that does not have a PIK3CA mutation. The approval covers patients whose disease has progressed after receiving at least one line of endocrine therapy for metastatic disease.

REVTORPYK becomes the first FDA-approved therapy to simultaneously inhibit all four Class I PI3K isoforms (α, β, δ, and γ) as well as both mTOR complexes, mTORC1 and mTORC2. This broad mechanism of action is designed to comprehensively target the PI3K/AKT/mTOR (PAM) signaling pathway, one of the most important pathways involved in cancer growth and treatment resistance.

Brian Sullivan, Chief Executive Officer and co-founder of Celcuity, said the approval represents a major milestone after nearly two decades of efforts by researchers to effectively target the PAM pathway. He noted that REVTORPYK is the first pan-PI3K and mTORC1/2 inhibitor to receive FDA approval and expressed appreciation for the opportunity to make this new treatment available to patients with HR+/HER2- advanced or metastatic breast cancer.

HR+/HER2- breast cancer is the most common form of breast cancer, accounting for nearly 70% of all breast cancer cases. Among these patients, approximately 60% have tumors that do not carry a PIK3CA mutation, representing a large patient population with limited targeted treatment options after disease progression.

Sara Hurvitz, M.D., Senior Vice President of the Clinical Research Division at Fred Hutchinson Cancer Center, Professor and Head of the Division of Hematology and Oncology at the University of Washington School of Medicine, and co-principal investigator of the Phase 3 VIKTORIA-1 trial, said there is a significant need for additional therapies that can delay disease progression in patients with HR+/HER2- metastatic breast cancer. She stated that the approval of REVTORPYK provides oncologists with an important new treatment option for patients whose cancer has progressed despite endocrine therapy.

The FDA approval was supported by positive results from the Phase 3 VIKTORIA-1 clinical trial, which evaluated the safety and effectiveness of REVTORPYK in patients with PIK3CA wild-type HR+/HER2- locally advanced or metastatic breast cancer following progression after treatment with both a CDK4/6 inhibitor and an aromatase inhibitor. The global, randomized, open-label study assessed REVTORPYK in combination with fulvestrant, with or without the CDK4/6 inhibitor palbociclib.

The strongest results were observed in the triplet therapy group, which combined REVTORPYK, palbociclib, and fulvestrant. Patients receiving this combination achieved a median progression-free survival of 9.3 months compared with 2.0 months for patients treated with fulvestrant alone, representing an improvement of 7.3 months. The treatment also produced an objective response rate of 32%, compared with just 1% in the fulvestrant group, while the median duration of response reached 17.5 months.

The doublet combination of REVTORPYK and fulvestrant also demonstrated meaningful clinical benefits. Patients treated with this regimen achieved a median progression-free survival of 7.4 months, compared with 2.0 months for fulvestrant alone, representing an improvement of 5.4 months. The objective response rate for the doublet therapy was 28%, with a median duration of response of 12 months. Because only one patient receiving fulvestrant alone achieved an objective response, a median duration of response could not be determined for the control group.

Igor Gorbatchevsky, M.D., Chief Medical Officer of Celcuity, said the FDA approval addresses a significant unmet need for thousands of patients with HR+/HER2-, PIK3CA wild-type advanced or metastatic breast cancer whose disease continues to progress despite endocrine therapy. He also expressed gratitude to the patients, caregivers, investigators, clinical research teams, and Celcuity employees whose contributions helped bring the therapy to approval.

Celcuity expects to commercially launch REVTORPYK during the latter part of the third quarter of 2026. To support patient access, the company has developed a comprehensive patient assistance program aimed at providing broad and affordable access to the treatment. Before the commercial launch, eligible patients will be able to receive REVTORPYK through the company's expanded access program.

The company also plans to continue expanding the potential use of REVTORPYK. During the third quarter of 2026, Celcuity expects to submit a supplemental New Drug Application (sNDA) to the FDA seeking approval for patients with HR+/HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer following at least one line of endocrine therapy. The application will be based on positive findings from the PIK3CA-mutated cohort of the Phase 3 VIKTORIA-1 trial, which were recently presented during a late-breaking oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Following the FDA submission, the company also plans to seek regulatory approvals in other countries using the VIKTORIA-1 clinical data.

In addition, REVTORPYK continues to be evaluated in the ongoing Phase 3 VIKTORIA-2 clinical program, which includes two independent studies investigating the therapy in patients with HR+/HER2- locally advanced or metastatic breast cancer who have not previously received treatment for advanced disease. These studies are intended to further evaluate the drug's potential in earlier treatment settings.