FDA places partial clinical hold on Merck and Daiichi Sankyo’s I-DXd lung cancer trial after interstitial lung disease deaths

FDA partial clinical hold; ifinatamab deruxtecan; I-DXd; IDeate-Lung02; Merck; Daiichi Sankyo; small cell lung cancer; interstitial lung disease; grade 5 ILD; antibody-drug conjugate; clinical trial deaths

Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial

Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation