FDA has approved Revtorpyk (gedatolisib) for the treatment of patients with hormone receptor positive, HER2-negative locally advanced or metastatic breast cancer without a Pik3ca mutation, following progression on at least one line of endocrine therapy in the metastatic setting.

The approval makes Revtorpyk the only inhibitor of all class I Pi3k isoforms and mTOR complexes to receive FDA clearance, ending a nearly two-decade effort to comprehensively target the Pi3k /AKT/mTOR pathway in cancer.¹

Celcuity is anticipating a commercial launch in late Q3 2026, with an expanded access program available for eligible patients in the interim.¹

What is the approval based on?

Revtorpyk’s approval is based on results from the Pik3ca wild-type cohort of the Phase III Viktoria-1 trial, an open-label, global, randomized study evaluating Revtorpyk plus fulvestrant, with or without palbociclib, in patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on CDK4/6 therapy and an aromatase inhibitor.²

The Revtorpyk triplet, Revtorpyk plus palbociclib and fulvestran, achieved a median progression-free survival of 9.3 months compared to 2.0 months with fulvestrant alone, an improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001).² The objective response rate for the triplet was 32% versus 1% for fulvestrant, with a median duration of response of 17.5 months.²

The Revtorpyk doublet, Revtorpyk plus fulvestrant, achieved a median progression-free survival of 7.4 months versus 2.0 months, an improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001), with an objective response rate of 28% and a median duration of response of 12.0 months.²

Why is this mechanism significant?

The Pi3k /AKT/mTOR pathway, sometimes called the PAM pathway, is one of the most frequently altered signaling networks in cancer and has long been considered a high-priority therapeutic target. Prior efforts to inhibit individual components of the pathway had limited success, in part because tumors can compensate by activating other nodes within the same network. Revtorpyk's pan- Pi3k and dual mTORC1/2 inhibition addresses multiple points simultaneously, a strategy that eluded developers for roughly 20 years.

"Revtorpyk addressed this 20-year challenge by becoming the first pan- Pi3k, mTORC1/2 inhibitor approved by the FDA," said Brian Sullivan, CEO and co-founder of Celcuity. "We are thankful for the opportunity to make this important new therapy available to patients with HR+/HER2- locally advanced or metastatic breast cancer."

Sara Hurvitz, senior vice president of the clinical research division at Fred Hutchinson Cancer Center and co-principal investigator for the Viktoria-1 trial, called the approval a meaningful step for a patient population with limited options after endocrine therapy. "With the approval of Revtorpyk, oncologists now have an effective new treatment option for these patients," Hurvitz said.

What comes next?

Following FDA’s approval, Celcuity plans to submit a supplemental new drug application to FDA in Q3 2026 for Revtorpyk in Pik3ca -mutated HR+/HER2- locally advanced or metastatic breast cancer, based on results from the mutant cohort of the Viktoria-1 trial presented as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology Annual Meeting.¹ Following that submission, the company intends to seek marketing authorization from regulatory authorities globally.

Revtorpyk is currently under evaluation in the ongoing Phase III Viktoria-2 trial, which incorporates two independent studies across separate patient cohorts with HR+/HER2- locally advanced or metastatic breast cancer who are treatment-naive in the advanced setting, potentially expanding the drug's addressable population well beyond its initial approval.

Sources

1. Celcuity Announces FDA Approval of Revtorpyk (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer Celcuity July 14, 2026 https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-approval-revtorpyktm-gedatolisib
2. Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/​HER2- Breast Cancer (VIKTORIA-1) (VIKTORIA-1) National Library of Medicine February 20, 2026 https://clinicaltrials.gov/study/NCT05501886