Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal — Live Feedhttps://www.live-feeds.com/feed/merck-daiichi-pull-lung-cancer-filing-after-fda-pushback-deals-another-blow-to-4b-dealContinuously updated, source-cited coverage. Merck and Daiichi Sankyo Withdraw Lung Cancer Drug Application After FDA Pushbackhttps://www.live-feeds.com/feed/merck-daiichi-pull-lung-cancer-filing-after-fda-pushback-deals-another-blow-to-4b-dealhttps://www.live-feeds.com/feed/merck-daiichi-pull-lung-cancer-filing-after-fda-pushback-deals-another-blow-to-4b-deal#u101198Mon, 05 Oct 2026 03:36:50 +0000Merck and Daiichi Sankyo have voluntarily withdrawn their Biologics License Application for ifinatamab deruxtecan (I-DXd) intended to treat adult patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). The decision follows discussions with the FDA, which determined that data from the IDeate-Lung01 Phase 2 trial did not meet the requirements for accelerated approval. While this application is scrapped, the companies are continuing patient enrollment in the Phase 3 IDeate-Lung02 trial to evaluate the drug against physician-selected chemotherapy.Why it mattersThis setba