Celcuity launches REVTORPYK for HR+/HER2- advanced breast cancer

Celcuity Inc. announced on September 30, 2026 that REVTORPYK (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.¹

The drug was approved in combination with palbociclib and fulvestrant ("REVTORPYK triplet") and in combination with fulvestrant ("REVTORPYK doublet"), by the FDA on July 14, 2026.¹

Company executives described the launch as building on prior groundwork. CEO Brian Sullivan said the company's commercial and medical affairs teams had been preparing for launch with healthcare providers, payers, and patient advocacy partners since approval, and are now focused on working with physicians to bring the treatment to patients.¹

In the pivotal trial data cited by the company, results from the PIK3CA wild-type cohort of the Phase 3 "VIKTORIA-1" study showed that the REVTORPYK triplet and REVTORPYK doublet cut the risk of disease progression or death by 76% and 67%, respectively, versus fulvestrant.¹

Celcuity also disclosed regulatory progress on a broader indication. The company said it filed a supplemental New Drug Application with the FDA in August seeking approval of REVTORPYK for HR+/HER2- advanced breast cancer patients with PIK3CA mutations, based on Study 2 of the VIKTORIA-1 trial, which if approved would let physicians prescribe the drug regardless of a patient's PIK3CA status.¹

The company launched a patient support program alongside the commercial rollout. Celcuity said it launched REVTORPYK Support Services to provide financial assistance and treatment enrollment resources for physicians and eligible patients, including help with insurance coverage and access to copay and patient assistance programs.¹