Biopharmaceutical company Syros Pharmaceuticals (NASDAQ:SYRS) announced on Tuesday that it has gained Fast Track Designation from the US Food and Drug Administration (FDA) for tamibarotene in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukaemia (AML) with RARA overexpression in adults over age 75 or with comorbidities that preclude the use of intensive induction chemotherapy.

Fast Track aims to expedite the review of drugs for serious conditions with unmet medical need, allowing for more frequent interactions with the FDA and potential for priority review and accelerated approval.

Tamibarotene, a first-in-class selective retinoic acid receptor alpha (RARα) agonist, is being evaluated in the SELECT-AML-1 Phase 2 trial, showing promising results with a 100% CR/CRi rate in response-evaluable patients.

Syros expects to report additional data from SELECT-AML-1 in 2024. It is also assessing tamibarotene in higher-risk myelodysplastic syndrome (MDS) patients in the SELECT-MDS-1 Phase 3 trial. The FDA granted Fast Track Designation to tamibarotene for the treatment of HR-MDS patients with RARA overexpression in January 2023.