The FDA has approved a new targeted therapy combination for the most common subtype of breast cancer.Gedatolisib (Revtorpyk, Celcuity Inc.) plus fulvestrant, with or without palbociclib (Ibrance, Pfizer), was approved for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression during or after

Gedatolisib is approved in combination with fulvestrant, with or without palbociclib

Celcuity's Revtorpyk wins FDA approval for use in HR+/HER2- breast cancer without a PIK3CA mutation.