On July 14, 2026, the Food and Drug Administration approved gedatolisib 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.

Full prescribing information for Revtorpyk will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in Study 1 of VIKTORIA-1 (NCT05501886), an open-label, randomised, multicenter trial that enrolled 392 adults with locally advanced (inoperable) or metastatic HR-positive, HER2-negative breast cancer. Patients were randomised (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).

There was a statistically significant improvement in PFS for Arm A vs Arm C, with a median PFS of 9.3 months (95% CI: 7.2, 16.6) in Arm A and 2.0 months (95% CI: 1.8, 2.3) in Arm C (hazard ratio [HR] 0.24 [95% CI: 0.17, 0.35]; p-value <0.0001). There was also a statistically significant improvement in PFS for Arm B vs Arm C with a median PFS of 7.4 months (95% CI: 5.5, 9.9) in Arm B and 2.0 months (95% CI: 1.8, 2.3) in Arm C (HR 0.33 [95% CI: 0.24, 0.48]; p-value <0.0001). ORR in patients with measurable disease was 32% (95% CI: 23, 40) in Arm A, 28% (95% CI: 20, 38) in Arm B, and 1% (95% CI: 0, 5) in Arm C. Median DoR was 17.5 months (95% CI: 8.8, not estimable [NE]) in Arm A, 12.0 months (95% CI: 8.1, NE) in Arm B, and NE (95% CI: NE, NE) in Arm C.

At the time of the PFS analysis, OS data were not mature with 25% deaths in the overall population.

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

Recommended Dosage

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.

This review used the Real-Time Oncology Review (RTOR) program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Source: FDA