Biotherapeutics company PureTech Health plc (PRTC) announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia (AML).
The Fast Track designation is a mechanism aimed at expediting the development process and hastening the evaluation of medications intended for serious illnesses that lack sufficient treatment options.
LYT-200 demonstrates its therapeutic benefits in acute myeloid leukemia (AML) by directly inducing apoptosis and causing DNA damage in cancer cells, while also reactivating key anti-cancer components of the immune system.
LYT-200 represents the cutting-edge clinical initiative targeting galectin-9 and is currently under assessment in two active clinical trials.
The FDA has awarded orphan drug designation to LYT-200 for treating AML, in addition to a distinct Fast Track designation for its use in recurrent/metastatic head and neck squamous cell carcinomas, when used alongside anti-PD1 therapy.
PureTech has previously stated its intention to progress LYT-200 through its Founded Entity, Gallop Oncology.
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