Shots:
- The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML)
- The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near doubling of complete responses in single arm study (n=38) vs historical SoC across molecular subtypes, and was well tolerated
- Based on preliminary findings Ipsen plans to engage with the US FDA to discuss P-II/III development plans in H1’26; IPN60340 previously received US FDA and EMA Orphan Drug Designations
Ref: GlobeNewswire | Image: Ipsen | Press Release
Related News: Ipsen Signs ~$1.06B Deal with Simcere Zaiming for SIM0613
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