The FDA has approved gedatolisib (Revtorpyk) in combination with fulvestrant (Faslodex), with or without palbociclib (Ibrance), for adults with hormone receptor (HR)-positive, HER2-negative advanced breast cancer without a PIK3CA mutation whose disease progressed during or after endocrine therapy for metastatic disease.
Gedatolisib blocks multiple proteins in the PI3K/AKT/mTOR pathway, helping overcome treatment resistance and making it effective in tumors with or without PIK3CA mutations.
The approval was based on the phase 3 VIKTORIA-1 trial, which included 392 patients. Patients receiving gedatolisib plus fulvestrant and palbociclib had a median progression-free survival of 9.3 months, compared with 2.0 months for fulvestrant alone. Gedatolisib plus fulvestrant achieved a median progression-free survival of 7.4 months. Both combinations also produced higher tumor response rates than fulvestrant alone.
The most common side effects included mouth sores, nausea, vomiting, rash, fatigue, high blood sugar, and neutropenia, which was more common when palbociclib was included.