Newly FDA-approved Revtorpyk wins NCCN listing

US biotech Celcuity (Nasdaq: CELC) announced that Revtorpyk (gedatolisib) in combination with fulvestrant, with or without palbociclib, is recommended by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred Category 1 second-line and/or subsequent-line therapy following progression on or after treatment with at least one line of endocrine therapy.

Revtorpyk was granted approval by the US Food and Drug Administration (FDA) on July 14, 2026, for the treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Revtorpyk is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval.