FDA approves Revtorpyk for advanced HR-positive, HER2-negative breast cancer

FDA has approved Revtorpyk (gedatolisib) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation whose disease has progressed after at least one line of endocrine therapy in the metastatic setting.

Patients whose tumors do not harbor a PIK3CA mutation have had relatively few biomarker-directed treatment options after progression on endocrine therapy. Revtorpyk is the first FDA-approved pan-PI3K/mTOR inhibitor, targeting a pathway commonly involved in endocrine resistance.

Approval was based on data from the phase 3 VIKTORIA-1 trial. Compared with fulvestrant alone, adding gedatolisib and palbociclib reduced the risk of disease progression or death by 76% and extended median progression-free survival from 2.0 months to 9.3 months. Gedatolisib plus fulvestrant reduced the risk by 67%, extending median progression-free survival to 7.4 months. Follow-up was not yet long enough to determine whether overall survival improved.

The prescribing information includes warnings for stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity. Because stomatitis was common, clinicians should initiate a steroid-containing, alcohol-free mouthwash before starting treatment and continue prophylactically during therapy.

"For patients with HR+/HER2− locally advanced or metastatic breast cancer, there is an urgent need for new treatment options that can meaningfully increase the likelihood of survival without disease progression or death," said Sara Hurvitz, MD, Senior Vice President of the Clinical Research Division at Fred Hutchinson Cancer Center and co-principal investigator of the VIKTORIA-1 trial. "With the approval of Revtorpyk, oncologists now have an effective new treatment option for these patients."

Sources: FDA. (2026 July 14). FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer; Celcuity. (2026 July 14). Celcuity Announces FDA Approval of REVTORPYK (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer