Celcuity's REVTORPYK (gedatolisib) now commercially available in US for HR+/HER2- advanced breast cancer

Celcuity Inc.

FDA approved REVTORPYK on July 14, 2026 as a triplet with palbociclib and fulvestrant, and as a doublet with fulvestrant, for HR+/HER2- ABC without a PIK3CA mutation.
In the Phase 3 VIKTORIA-1 PIK3CA wild-type cohort, the REVTORPYK triplet and doublet cut risk of disease progression or death by 76% and 67% versus fulvestrant.
Celcuity launched REVTORPYK Support Services offering insurance coverage, Copay Assistance and Patient Assistance help; contact 877-423-5284 or www.revtorpykhcp.com.
A supplemental NDA was submitted to the FDA in August for REVTORPYK in HR+/HER2-, PIK3CA-mutated advanced breast cancer based on Study 2 of VIKTORIA-1.

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