FDA grants Breakthrough Therapy Designation to Ipsen’s IPN60340 (ICT01) for first-line treatment of unfit acute myeloid leukemia. This designation aims to expedite the development and review process for this promising therapy.
Kone AS, Ait Ssi S, Sahraoui S, ... and Treatment. Int J Mol Sci. 2022;23(21):13424. Published 2022 Nov 3. doi:10.3390/ijms232113424 ... New data reinforces Ipsen’s commitment to bringing solutions and addressing care gaps in neurological diseases at TOXINS ... Ipsen expands early development pipeline with Simcere Zaiming’s innovative antibody drug conjugate ... Ipsen update on Phase II FALKON trial in patients with ultra-rare bone disease, ... Kone AS, Ait Ssi S, Sahraoui S, Badou A. BTN3A: A Promising Immune Checkpoint for Cancer Prognosis and Treatment. Int J Mol Sci. 2022;23(21):13424. Published 2022 Nov 3. doi:10.3390/ijms232113424 ... New data reinforces Ipsen’s commitment to bringing solutions and addressing care gaps in neurological diseases at TOXINS ... Ipsen expands early development pipeline with Simcere Zaiming’s innovative antibody drug conjugate ... Ipsen update on Phase II FALKON trial in patients with ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP) This Breakthrough Therapy Designation is based on data from the Phase I/II EVICTION trial. Updated clinical data orally presented at the American Society of Hematology (n=57)1 from the EVICTION trial showed treatment with IPN60340 in combination with Ven-Aza achieved very encouraging high responses. IPN60340 is an investigational therapy under evaluation for people 75 years or older living with acute myeloid leukemia who due to comorbidities are prevented from receiving treatment with intensive chemotherapy. About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of IPN60340 (ICT01) in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML.
Original title: “U.S. FDA grants Ipsen’s IPN60340 (ICT01) Breakthrough Therapy Designation in first line unfit Acute Myeloid Leukemia”