Celcuity's REVTORPYK Recommended by NCCN Guidelines
Celcuity Inc. announced that its recently FDA-approved drug, REVTORPYK (gedatolisib), has been recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a preferred Category 1 second-line and/or subsequent-line therapy for HR+/HER2- locally advanced or metastatic breast cancer. This NCCN inclusion, shortly after its July 14, 2026 FDA approval, highlights the drug's clinical relevance and is expected to increase awareness and support treatment decision-making. REVTORPYK demonstrated significant improvements in progression-free survival and objective response rates in the VIKTORIA-1 trial. The drug is expected to be commercially available in the U.S. in late Q3 2026, with an expanded access program available prior to launch.
Key Highlights
- REVTORPYK recommended by NCCN Guidelines as preferred Category 1 therapy.
- FDA approved REVTORPYK on July 14, 2026.
- Triplet therapy showed median PFS of 9.3 months vs 2.0 months for fulvestrant.
- Triplet therapy achieved 32% objective response rate.
- Doublet therapy showed median PFS of 7.4 months vs 2.0 months for fulvestrant.
- Doublet therapy achieved 28% objective response rate.
- Commercial availability expected in late Q3 2026 in the U.S.
Price Impact
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