Onco-Summaries: Daily Oncology Updates at a Glance

13/01/2026

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• Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML

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Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML (Ref)

The US FDA granted the Breakthrough Therapy Designation to Ipsen's IPN60340 (anti-BTN3A) in combination with venetoclax and azacitidine in first line unfit acute myeloid leukemia.

• Christelle Huguet, PhD, EVP and Head of R&D, Ipsen: “This Breakthrough Therapy Designation recognizes both the urgent need for new treatment options for people living with acute myeloid leukemia and the promising data seen so far in the development program for IPN60340. We look forward to working closely with the FDA as we advance to the next stage of clinical development and continue to deliver medicines with the potential to be transformative to people living with cancer.”

• The designation is based on data from the Phase I/II EVICTION trial

• Ipsen plans to discuss the design of the Phase II/III development plans with the FDA for IPN60340 in H1 2026