FDA Approves Celcuity’s Revtorpyk (gedatolisib) for HR-Positive, HER2-Negative Metastatic Breast Cancer in New Combination Regimen

July 19, 2026

FDA USA

Overview

On July 14, 2026, the FDA approved Celcuity Inc.’s Revtorpyk (gedatolisib) for adult patients with HR-positive/HER2-negative metastatic breast cancer without PIK3CA mutation. The drug is approved for use in combination with fulvestrant, with or without palbociclib. The pivotal VIKTORIA-1 trial demonstrated that gedatolisib significantly improved progression-free survival, offering a new standard of care option.

In Depth

Key Findings

On July 14, 2026, the U.S. Food and Drug Administration (FDA) granted approval to Celcuity Inc.’s Revtorpyk (gedatolisib) for adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation. This approval allows for gedatolisib to be used in combination with fulvestrant, with or without palbociclib, introducing a new therapeutic option for patients battling advanced breast cancer.

Technical & Clinical Details

Gedatolisib is a small-molecule inhibitor targeting the PI3K/mTOR pathway, a critical signaling cascade involved in breast cancer cell proliferation and survival. The approval was based on data from the Phase III VIKTORIA-1 trial, which showed that combination regimens involving gedatolisib with fulvestrant, or a triple combination including palbociclib, significantly improved progression-free survival (PFS) compared to control arms. The trial also reported enhanced objective response rates and a manageable safety profile. While specific median PFS improvement values and response rates were not detailed in the summary, the efficacy was deemed clinically meaningful by the regulatory body.

Background & Context

HR-positive/HER2-negative breast cancer represents the most common subtype, and patients with advanced or metastatic disease often face challenges with treatment resistance and disease progression. There has been a high unmet need for novel effective therapies for patients without PIK3CA mutations, and the approval of gedatolisib addresses this gap. The drug is designed to work synergistically with existing hormone therapies and CDK4/6 inhibitors to maximize therapeutic benefit.

Strategic Significance & Outlook

The approval of Revtorpyk (gedatolisib) opens a new avenue in the treatment strategy for HR-positive/HER2-negative metastatic breast cancer. It is particularly significant for the subset of patients without PIK3CA mutations, where it is expected to contribute to more prolonged disease control and improved quality of life when integrated into standard treatment protocols. Further real-world evidence and long-term follow-up studies will be crucial in solidifying its clinical value. This development also has implications for the broader landscape of PI3K/mTOR pathway inhibitors and combination therapies in oncology.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally

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