Merck and Daiichi Sankyo withdraw I-DXd lung cancer filing after FDA says data do not support accelerated approval
Merck and Daiichi Sankyo have withdrawn their accelerated-approval application for the lung cancer ADC I-DXd after the FDA said the available data were insufficient for that pathway. The filing had relied on phase 2 results, but regulators indicated the evidence did not meet the bar for accelerated approval. The setback adds to pressure on the partners’ three-ADC collaboration, which Merck backed with a $4 billion upfront payment in 2023, after another program, HER3-DXd, was rejected by the FDA in 2024 over manufacturing issues.