FDA Grants Breakthrough Therapy Designation to Ipsen’s IPN60340 for First-Line Unfit Acute Myeloid Leukemia

Reuters01-14

FDA Grants Breakthrough Therapy Designation to Ipsen’s IPN60340 for First-Line Unfit Acute Myeloid Leukemia

Ipsen SA announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for IPN60340 in combination with venetoclax and azacitidine for first-line treatment of unfit acute myeloid leukemia (AML). IPN60340 is an investigational monoclonal antibody targeting BTN3A. The designation is supported by data from the Phase I/II EVICTION trial, which were presented at the American Society of Hematology and showed that the combination therapy achieved high response rates and was well tolerated in newly diagnosed AML patients, including those with subtypes less responsive to standard of care. Ipsen plans to discuss Phase II/III development plans with the FDA in the first half of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ipsen SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001159118-en) on January 13, 2026, and is solely responsible for the information contained therein.

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IPN60340 is an investigational monoclonal antibody targeting BTN3A. The designation is supported by data from the Phase I/II EVICTION trial, which were presented at the American Society of Hematology and showed that the combination therapy achieved high response rates and was well tolerated in newly diagnosed AML patients, including those with subtypes less responsive to standard of care. Ipsen plans to discuss Phase II/III development plans with the FDA in the first half of 2026.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ipsen SA published the original content used to generate this news brief via GlobeNewswire (Ref. 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