Merck and Daiichi Sankyo withdraw I-DXd lung cancer filing after FDA says data do not support accelerated approval
AI Market Summary
Merck and Daiichi Sankyo withdrew the accelerated-approval filing for B7-H3 ADC ifinatamab deruxtecan in extensive-stage small cell lung cancer after FDA said the phase 2 dataset did not meet the evidentiary bar. The setback further delays potential monetization of Merck's 2023 $4B-upfront ADC partnership and follows prior FDA issues on the HER3-DXd program, pressuring near-term oncology pipeline expectations.
Impact level
● Medium
Affected assets
NCSKMRK2USD/USDT-2.84%
AI Insight · NCSKMRK2USD/USDTAI Insight
▼ Bearish
Trade now
⚠️ AI-generated insights are based on news content and are provided for informational purposes only. They do not constitute investment advice or represent the views of BingX. Investing involves risk. Please trade responsibly.
Merck and Daiichi Sankyo have withdrawn their accelerated-approval application for the lung cancer ADC I-DXd after the FDA said the available data were insufficient for that pathway.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.
