Celcuity Announces Commercial Availability of REVTORPYK in the U.S.

Celcuity Inc. announced on September 30, 2026, that REVTORPYK (gedatolisib) is now commercially available in the United States. The company stated that the drug is indicated for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer (ABC) who do not have a detected PIK3CA mutation. These patients must have progressed following at least one line of endocrine therapy in the metastatic setting.

REVTORPYK received approval from the U.S. Food and Drug Administration (FDA) on July 14, 2026. It is authorized for use in two combinations: as a triplet with palbociclib and fulvestrant, and as a doublet with fulvestrant alone.

According to the filing, REVTORPYK is the first and only FDA-approved therapy to inhibit all class I PI3K isoforms (alpha, beta, delta, gamma) and mTOR complexes mTORC1 and mTORC2. In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the drug reduced the risk of disease progression or death by 76% when used as a triplet and by 67% as a doublet, compared to fulvestrant.

Celcuity has launched the REVTORPYK Support Services program to assist healthcare providers and patients. This program offers support with insurance coverage, reimbursement, and financial assistance, including Copay and Patient Assistance Programs. Providers can access these resources at www.revtorpykhcp.com or by calling 877-4-CELCUITY (877-423-5284).

The company also noted that it submitted a supplemental New Drug Application to the FDA in August for REVTORPYK to treat patients with HR+/HER2- advanced breast cancer regardless of their PIK3CA tumor status. Additionally, Celcuity is conducting a Phase 3 trial, VIKTORIA-2, evaluating the drug in first-line settings for endocrine-resistant and endocrine-sensitive patients, as well as a Phase 1b/2 trial, CELC-G-201, combining gedatolisib with darolutamide for metastatic castration-resistant prostate cancer.

The press release includes a detailed Important Safety Information section regarding adverse reactions. These include stomatitis (oral ulcers), which occurred in 72% of patients in the triplet regimen and 58% in the doublet; severe rash; and hyperglycemia. The safety profile also includes warnings regarding embryo-fetal toxicity and the need for contraception during treatment.