FDA grants fast track status to Faeth's PIKTOR combo for endometrial cancer

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Go back to FDA grants fast track status to Faeth's PIKTOR combo for endometrial cancer

Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer

August 17, 2026 7:30 AM EDT

Fast Track designation applies to sapanisertib and serabelisib (PIKTOR) in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration

Faeth expects topline data from its ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201) by year-end 2026

AUSTIN, Texas--(BUSINESS WIRE)-- Faeth Therapeutics... More