On Jul. 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

Efficacy was evaluated in Study 1 of VIKTORIA-1 (NCT05501886), an open-label, randomized, multicenter trial that enrolled 392 adults with locally advanced (inoperable) or metastatic HR-positive, HER2-negative breast cancer. Patients were randomized (1:1:1) to receive either gedatolisib in combination with fulvestrant and palbociclib (Arm A), gedatolisib in combination with fulvestrant (Arm B), or fulvestrant alone (Arm C). Patients received treatment until disease progression or unacceptable toxicity.

The major efficacy outcome measure was comparison of progression-free survival (PFS) assessed by blinded independent central review between patients enrolled in Arm A and Arm C, and between patients enrolled in Arm B and Arm C, evaluated according to RECIST version 1.1. Additional efficacy outcome measures were overall survival (OS), objective response rate (ORR), and duration of response (DoR).

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 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. Refer to the prescribing information for fulvestrant and palbociclib for additional dosing information.