REVTORPYK (gedatolisib) + fulvestrant, with or without palbociclib
HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer · Adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on or after at least one endocrine-therapy line in the metastatic setting
CELC · Celcuity
Regulatory designations
Full timeline
6 milestonesFDA approved REVTORPYK regimens
FDA approved REVTORPYK with fulvestrant, with or without palbociclib, for the specified HR-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer population. The approval came three days before the July 17 PDUFA date.
FDA — REVTORPYK approval↗VIKTORIA-1 results were published
The PIK3CA wild-type cohort results were published in the Journal of Clinical Oncology. The triplet and doublet reduced the risk of progression or death by 76% and 67%, respectively, versus fulvestrant.
Celcuity — Publication of VIKTORIA-1 results↗FDA accepted the NDA with Priority Review
FDA accepted the gedatolisib NDA, granted Priority Review and assigned a July 17, 2026 PDUFA goal date. The application was submitted under the Real-Time Oncology Review program.
Celcuity — NDA acceptance and Priority Review↗Updated VIKTORIA-1 results were presented
Celcuity presented updated efficacy and safety findings from the PIK3CA wild-type cohort at the 2025 San Antonio Breast Cancer Symposium.
Celcuity — Updated VIKTORIA-1 results↗Related News
Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update
Aug 6, 2026Celcuity Schedules Release of Second Quarter 2026 Financial Results and Webcast/Conference Call
Jul 30, 2026Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast Cancer
Jul 14, 2026Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer
Jun 4, 2026Celcuity Inc. Announces Pricing of Upsized Public Offering of 0.250% Convertible Senior Notes Due 2032