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FDA grants fast track designation for LYT-200 in R/R AML and MDS
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On January 9, 2025, the U.S. Food and Drug Administration (FDA) granted fast track designation for LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).1 LYT-200 was previously granted orphan drug designation on March 14, 2024.2
LYT-200 is currently being evaluated in a phase I/II trial (NCT05829226) both as monotherapy and in combination with the standard-of-care venetoclax and hypomethylating agents (HMAs) for the treatment of patients with R/R AML/MDS who have received ≥1 line of prior treatment. Data presented during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition 2024 showed that3:
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Of 22 evaluable patients receiving LYT-200 monotherapy, 59% achieved stable disease or better, with two partial responses.
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Of 15 evaluable patients receiving LYT-200 in combination with venetoclax/HMA, 80% attained stable disease or better, including two complete responses and one morphologic leukemia free state.
- Business Wire. PureTech receives FDA fast track designation for LYT-200 in acute myeloid leukemia (AML). https://www.businesswire.com/news/home/20250109191836/en/PureTech-Receives-FDA-Fast-Track-Designation-for-LYT-200-in-Acute-Myeloid-Leukemia-AML. Published Jan 9, 2025. Accessed Jan 10, 2025.
- PureTech. PureTech receives orphan drug designation for LYT-200 in acute myeloid leukemia. https://news.puretechhealth.com/news-releases/news-release-details/puretech-receives-orphan-drug-designation-lyt-200-acute-myeloid Published Mar 13, 2024. Accessed Jan 10, 2025.
- Nasdaq. PureTech presents data for LYT-200 (anti-galectin-9 monoclonal antibody) for relapsed/refractory AML/MDS at the 2024 ASH Annual Meeting. https://www.nasdaq.com/press-release/puretech-presents-data-lyt-200-anti-galectin-9-monoclonal-antibody-relapsed. Published Dec 9, 2024. Accessed Jan 10, 2025.
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