On July 14, 2026, the FDA approved gedatolisib (Revtorpyk) 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 after progression on or after at least 1 line of endocrine therapy in the metastatic setting. The approval was based on Study 1 of the VIKTORIA-1 trial, a randomized, open-label study of 392 patients in whom gedatolisib combinations improved progression-free survival (PFS) compared with fulvestrant alone.
In the trial, median PFS was 9.3 months with gedatolisib, fulvestrant, and palbociclib and 7.4 months with gedatolisib plus fulvestrant, versus 2.0 months with fulvestrant alone. Objective response rates were also higher with the gedatolisib-containing regimens, and median duration of response was longer in both active treatment arms. Overall survival data were not mature at the time of analysis.
The recommended dosage is 180 mg intravenously over 30 minutes once weekly on days 1, 8, and 15 of each 28-day cycle, in combination with fulvestrant, with or without palbociclib, until disease progression or unacceptable toxicity. The prescribing information includes warnings for stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity.
Source
- 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. Accessed July 20, 2026. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locallyr