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

Faeth Therapeutics (Nasdaq: FTH) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational combination therapy PIKTOR — comprising sapanisertib and serabelisib — when used with paclitaxel for the treatment of advanced or recurrent endometrial cancer.

The designation applies specifically to patients whose tumors harbor a PI3K/AKT/mTOR pathway alteration and who have previously received platinum-based chemotherapy and an immune checkpoint inhibitor.

PIKTOR is an all-oral combination designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature cited by the company, this pathway is dysregulated in up to 50% of all solid tumors.

The company is currently evaluating PIKTOR in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data expected by year-end 2026. PIKTOR is also being assessed in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April, with interim data anticipated in 2027.

"Fast Track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor," said Anand Parikh, Chief Executive Officer of Faeth Therapeutics.

Faeth Therapeutics is a clinical-stage biotechnology company based in Austin, Texas, focused on oncology drug development. The information above is based on a company press release.

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