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FDA gives Syros fast track designation for tamibarotene for HR-MDS treatment
The Fly

FDA gives Syros fast track designation for tamibarotene for HR-MDS treatment

Syros Pharmaceuticals announced that the United States Food and Drug Administration, FDA, has granted Fast Track Designation to tamibarotene for the treatment of higher-risk myelodysplastic syndrome or HR-MDS. Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha agonist, is currently being evaluated in combination with azacitidine for the treatment of newly diagnosed HR-MDS patients with RARA gene overexpression. "Receipt of Fast Track designation for tamibarotene underscores both the potential of tamibarotene and the unmet need for HR-MDS patients, who have a poor prognosis due to the progressive nature of the disease," said David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals. "No new therapies beyond hypomethylating agents have been approved since 2006, and approximately half of all patients diagnosed with HR-MDS patients ultimately progress to AML. We are grateful for the opportunity to potentially expedite the delivery of tamibarotene as a new standard of care for this population." ..Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed unfit AML patients with RARA overexpression, with initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial expected in the fourth quarter of 2023 and additional data in 2024.

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