Celcuity's breast cancer drug Revtorpyk (gedatolisib) has received FDA approval as the first pan-PI3K and mTORC1/2 inhibitor approved for certain advanced breast cancer patients.
Revtorpyk is indicated for HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation after progression on or after at least one line of endocrine therapy.
The approval is based on the Phase 3 VIKTORIA-1 trial, where Revtorpyk combined with fulvestrant and palbociclib reduced the risk of disease progression or death by 76% (median PFS 9.3 vs 2.0 months vs fulvestrant alone).
Celcuity anticipates a commercial launch of Revtorpyk in the U.S. in late Q3 2026, marking its first marketed product and transition into a commercial-stage company.
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