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.
About Syros Pharmaceuticals
Syros is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is advancing a robust late-stage clinical pipeline, including tamibarotene, a first-in-class oral selective RARα agonist in patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression, and SY-2101, a novel oral form of arsenic trioxide in patients with acute promyelocytic leukemia. Syros is also seeking partnerships for SY-5609, a highly selective and potent CDK7 inhibitor in clinical development for the treatment of select solid tumors, and multiple preclinical programs in oncology and monogenic diseases.
January 27, 2023
