Celcuity's REVTORPYK™ Gains NCCN Guideline Inclusion for Advanced Breast Cancer
Event summary
- Celcuity's REVTORPYK™ (gedatolisib) included in NCCN Guidelines as a preferred second-line therapy for HR+/HER2- advanced breast cancer.
- REVTORPYK received FDA approval on July 14, 2026, for treating patients without PIK3CA mutation after progression on endocrine therapy.
- Phase 3 VIKTORIA-1 trial showed median PFS improvement of 7.3 months with REVTORPYK triplet vs. fulvestrant alone.
- REVTORPYK is the only FDA-approved inhibitor of class I PI3K isoforms and mTOR complexes mTORC1/mTORC2.
The big picture
Celcuity's strategic win with NCCN guideline inclusion positions REVTORPYK as a key player in HR+/HER2- advanced breast cancer treatment. The rapid adoption of the therapy could disrupt the competitive landscape, particularly for existing endocrine-based treatments. With ongoing trials exploring first-line applications and other cancer indications, Celcuity is expanding its footprint in precision oncology.
What we're watching
- Market Adoption
- How quickly oncologists incorporate REVTORPYK into treatment protocols following NCCN guideline inclusion.
- Commercialization Pace
- Whether Celcuity can meet its target for U.S. commercial availability in late Q3 2026.
- Pipeline Progress
- The pace of advancing REVTORPYK into first-line breast cancer and prostate cancer indications.
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