Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate

The FDA granted Syros Pharmaceuticals Fast Track status for its drug candidate tamibarotene for the treatment of higher-risk myelodysplastic syndrome, a group of disorders caused by a disruption in the production of blood cells that can lead to leukemia.

Tamibarotene is a retinoic acid receptor alpha (RARA) agonist that is being evaluated with azacitidine in a phase 3 trial in patients with newly diagnosed higher-risk myelodysplastic syndrome and who have overexpression of the RARA gene.

No new therapies beyond hypomethylating agents such as azacitidine, which trigger the reprogramming of tumor cells, have been approved since 2006 for this patient population, the company said.

Drugs that gain Fast Track status from the FDA are eligible for more frequent meetings and written communications with the agency to expedite their review.