Ifinatamab Deruxtecan Receives FDA Breakthrough Therapy Status for Lung Cancer
The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ifinatamab deruxtecan (I-DXd) for patients with extensive-stage small cell lung cancer (ES-SCLC) who no longer respond to platinum-based chemotherapy.
I-DXd is an investigational antibody–drug conjugate aimed at the B7-H3 protein and is being developed jointly by Daiichi Sankyo and Merck.
Breakthrough status is reserved for therapies that show early evidence of delivering significant advantages over current standards and are intended to expedite the path toward approval.
The designation is based on results from the IDeate-Lung01 Phase 2 trial, backed by findings from the IDeate-PanTumor01 Phase 1/2 study.
Full results from IDeate-Lung01 will be unveiled during a late-breaking presentation at the 2025 World Conference on Lung Cancer hosted by IASLC.
This is the first Breakthrough Therapy Designation granted to ifinatamab deruxtecan and the first earned under the collaboration between Daiichi Sankyo and Merck, highlighting the critical demand for more treatment choices in relapsed ES-SCLC and the potential of I-DXd to meet that need.
