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Wire · opportunities

Ifinatamab Deruxtecan BLA Voluntarily Withdrawn in Previously Treated Extensive-Stage SCLC

26 September 2026 · By · Wire by Fusion42

Published

26 September 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at onclive.com →

◆ Verified

Fusion42 · 26 September 2026 · Fusion42 review

Merck and Daiichi Sankyo voluntarily withdrew the biologics license application for ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer after the FDA found phase 2 data insufficient for accelerated approval. The phase 3 IDeate-Lung02 trial is nearing completion and may support a future approval filing.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You must rethink plans relying on accelerated FDA approval for novel lung cancer drugs as trial data standards tighten. Preparing for phase 3 results and further regulatory dialogue is now your urgent priority.

◆ Coverage

1 source · 26 Sep 2026

◆ Related on Wire

◆ Topics

Biotechdrug-withdrawalfdalung-cancerclinical-trialaccelerated-approval