FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer

Regulatory approval: On July 14, 2026, the FDA approved gedatolisib (Revtorpyk; Celcuity) with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on/after at least one line of endocrine therapy in the metastatic setting. Approval was supported by VIKTORIA-1 Study 1, where gedatolisib-containing arms significantly improved PFS versus fulvestrant alone; OS data were not mature.

FDA approval (July 14, 2026)

The FDA approved gedatolisib (Revtorpyk; Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after ≥1 line of endocrine therapy in the metastatic setting.

Supporting evidence: VIKTORIA-1 Study 1 (NCT05501886)

Study 1 was an open-label, randomized, multicenter trial enrolling 392 adults with inoperable locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients were randomized 1:1:1 to:

  • Arm A: gedatolisib + fulvestrant + palbociclib
  • Arm B: gedatolisib + fulvestrant
  • Arm C: fulvestrant alone

Primary endpoint: PFS by blinded independent central review (RECIST v1.1).

  • Arm A vs C: median PFS 9.3 vs 2.0 months; HR 0.24 (95% CI 0.17–0.35); p<0.0001
  • Arm B vs C: median PFS 7.4 vs 2.0 months; HR 0.33 (95% CI 0.24–0.48); p<0.0001

In measurable disease, ORR was 32% (Arm A), 28% (Arm B), and 1% (Arm C). At the time of PFS analysis, OS data were not mature (25% deaths overall).

Safety and dosing highlights

Label warnings/precautions include stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity. Recommended gedatolisib dosing: 180 mg IV over 30 minutes weekly on Days 1, 8, and 15 of each 28-day cycle, with fulvestrant ± palbociclib, until progression or unacceptable toxicity.

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