FDA Approval

FDA Approves Gedatolisib After Endocrine Therapy Progression in Advanced Breast Cancer

Edited by:
Anthony Calabro, MA

Key Highlights

  • The FDA approved gedatolisib for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected.
  • The indication applies after progression on or after at least 1 line of endocrine therapy in the metastatic setting.
  • In VIKTORIA-1, median progression-free survival was 9.3 months with gedatolisib, fulvestrant, and palbociclib vs 2 months with fulvestrant alone.
  • Median progression-free survival was 7.4 months with gedatolisib and fulvestrant vs 2 months with fulvestrant alone.

On July 14, the FDA approved gedatolisib (Revtorpyk, Celcuity Inc) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after at least 1 line of hormone therapy in the metastatic setting.

Efficacy was evaluated in study 1 of VIKTORIA-1, an open-label, randomized, multicenter trial of 392 adults with locally advanced, inoperable, or metastatic HR-positive, HER2-negative breast cancer. Patients were randomly assigned 1:1:1 to receive gedatolisib with fulvestrant and palbociclib, gedatolisib with fulvestrant, or fulvestrant alone. Patients received treatment until there was disease progression or unacceptable toxicity.

The major efficacy outcome measure was progression-free survival assessed by blinded independent central review, comparing gedatolisib with fulvestrant and palbociclib vs fulvestrant alone and gedatolisib with fulvestrant vs fulvestrant alone. Median progression-free survival was 9.3 months with gedatolisib, fulvestrant, and palbociclib vs 2 months with fulvestrant alone. Median progression-free survival was 7.4 months with gedatolisib and fulvestrant vs 2 months with fulvestrant alone. The objective response rate among patients with measurable disease was 32% with gedatolisib, fulvestrant, and palbociclib; 28% with gedatolisib and fulvestrant; and 1% with fulvestrant alone. Overall survival data were not mature at the time of the progression-free survival analysis, with 25% of patients having died in the overall population.

The prescribing information includes warnings and precautions for stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity.

The recommended dosage for gedatolisib is 180 mg as an intravenous infusion over 30 minutes administered once weekly on days 1, 8, and 15 of every 28-day cycle in combination with fulvestrant, with or without palbociclib, until disease progression or unacceptable toxicity. The FDA directs clinicians to the prescribing information for fulvestrant and palbociclib for additional dosing information.

Reference
US Food and Drug Administration. FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer. Published July 14, 2026. Accessed July 15, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally