The US FDA has granted fast track designation to Faeth Therapeutics’ investigational combination PIKTOR plus paclitaxel for advanced or recurrent endometrial cancer — a step meant to speed development of therapies for serious conditions with unmet need.
PIKTOR pairs two oral drugs, sapanisertib and serabelisib, and is designed to block multiple points along the PI3K/AKT/mTOR pathway — a signaling cascade altered in up to half of all solid tumors. According to the company, preclinical data suggest the approach can resensitize tumors to chemotherapy.
Which patients
The designation covers patients with PI3K/AKT/mTOR pathway alterations whose disease has progressed after platinum-based chemotherapy and an immune checkpoint inhibitor — a group with limited options. “Significant unmet need” remains for these patients, said Faeth CEO Anand Parikh.
Where the science stands
A Phase 2 study (FTH-PIK-201) is under way, with topline results expected by the end of 2026. Faeth is also running a Phase 1b/2 trial in HR+/HER2- breast cancer, which dosed its first patient in April 2026, with interim results expected in 2027. Fast track is a development designation, not an approval — the combination remains investigational.