FDA clears Celcuity’s Revtorpyk for breast cancer

On July 14, 2026, the U.S. Food and Drug Administration approved gedatolisib under the brand name Revtorpyk for adults with hormone receptor–positive, HER2‑negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected. The indication applies to patients whose disease has progressed on or after at least one line of endocrine therapy in the metastatic setting. The approval specifies use in combination with fulvestrant, with or without the CDK4/6 inhibitor palbociclib, expanding systemic treatment options for this subgroup of metastatic breast cancer patients.

By defining the population as PIK3CA wild‑type, the authorization focuses on patients who do not have a detectable PIK3CA mutation. The label allows clinicians to use Revtorpyk either as a doublet regimen with fulvestrant or as part of a triplet regimen with fulvestrant and palbociclib, providing flexibility in tailoring therapy within the approved setting.

The FDA decision was supported by results from the Phase 3 VIKTORIA‑1 trial. In this study, a triplet regimen of gedatolisib, palbociclib and fulvestrant reduced the risk of disease progression or death by 76% compared with fulvestrant alone, corresponding to a hazard ratio of 0.24. Median progression‑free survival was 9.3 months for patients receiving the triplet combination, versus 2.0 months for those treated with fulvestrant alone.

The trial also evaluated a doublet regimen of gedatolisib plus fulvestrant in the PIK3CA wild‑type cohort. This combination reduced the risk of progression or death by 67%, with a hazard ratio of 0.33. Median progression‑free survival reached 7.4 months with the doublet regimen, compared with 2.0 months for fulvestrant alone, demonstrating a substantial benefit even without palbociclib.

Together, these data show that adding gedatolisib to fulvestrant, with or without palbociclib, produced marked improvements in progression‑free survival over fulvestrant monotherapy in the studied population. These efficacy outcomes formed the main clinical basis for the newly granted approval.

Celcuity expects to commercially launch Revtorpyk in late third quarter 2026 in the United States. Ahead of full commercial availability, the company plans to offer an expanded access program so that eligible patients can receive the treatment prior to launch. This approach is intended to bridge the period between regulatory clearance and market rollout for patients meeting the approved indication.

In parallel with launch preparations, Celcuity plans to submit a supplemental new drug application in the third quarter of 2026 to seek an expanded indication for patients with PIK3CA‑mutated breast cancer. While the current approval is limited to tumors without a PIK3CA mutation detected, the planned filing signals an effort to extend gedatolisib’s potential use across a broader molecular spectrum, subject to regulatory review and supporting data.

Financial markets responded positively to the FDA decision. Following the announcement on July 14, 2026, Celcuity shares rose roughly 7% in afternoon and extended trading. The share price move reflects investor reaction to the first FDA approval of gedatolisib and expectations tied to the planned commercial launch and additional regulatory steps.