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News
Daiichi Sankyo and Merck have voluntarily pulled their FDA application for ifinatamab deruxtecan (I-DXd) in previously treated extensive-stage small cell lung cancer (ES-SCLC), after regulators signaled the phase 2 data wasn't enough for accelerated approval. The drug had shown a nearly 50% response rate in trials, but that wasn't sufficient to clear the bar. A phase 3 trial is still underway and could support a future filing.
Daiichi Sankyo and Merck have voluntarily withdrawn their biologics license application (BLA) for ifinatamab deruxtecan (I-DXd) — a B7-H3-directed antibody-drug conjugate — in adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed after platinum-based chemotherapy. The move came after FDA discussions indicated that data from the phase 2 IDeate-Lung01 trial fell short of accelerated approval requirements, despite the BLA having received priority review just months earlier in April 2026.
The phase 2 trial had shown a confirmed objective response rate of 48.2% and a median progression-free survival of 4.9 months at the 12 mg/kg dose — promising numbers in a notoriously hard-to-treat cancer. However, the FDA was not convinced the evidence met the threshold for accelerated approval.
By the Numbers:
Why it matters: ES-SCLC remains one of oncology's toughest challenges with very limited second-line options. The ongoing phase 3 IDeate-Lung02 trial (targeting 540 patients, with overall survival as the primary endpoint) could still pave the way for future approval — keeping hope alive for patients who desperately need new treatments.
