The designation applies specifically to patients whose tumours contain a phosphatidylinositol 3-kinase / protein kinase B / mechanistic target of rapamycin (PI3K/AKT/mTOR) pathway alteration.
It also applies to those who have previously undergone platinum-based chemotherapy and an immune checkpoint inhibitor.
Faeth Therapeutics is currently conducting a Phase II trial of this treatment approach, known as Study FTH-PIK-201, in second-line advanced endometrial cancer.
The company anticipates releasing top line results from this trial by the end of this year.
Faeth Therapeutics CEO Anand Parikh said: “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.
“We believe PIKTOR’s multi-node approach to the PI3K/AKT/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitise patients to chemotherapy.”
PIKTOR is described as an investigational, all-oral combination therapy and is designed to inhibit several nodes of the PI3K/AKT/mTOR pathway, which, according to published literature, is altered in up to half of all solid tumours.
In addition to the endometrial cancer trial, PIKTOR is being tested in a Phase Ib/II study for hormone receptor positive / human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer, referred to as Study FTH-PIK-101.
The first patient in this study was dosed in April, with interim results expected in 2027.
Faeth Therapeutics focuses on multi-node therapies for cancer, with PIKTOR as its leading development programme.