Daiichi Sankyo, Merck withdraw bid for accelerated approval of I-DXd in small cell lung cancer
Daiichi Sankyo and Merck withdrew their FDA application for accelerated approval of I-DXd (ifinatamab deruxtecan) in small cell lung cancer. The FDA indicated the data did not meet the requirements for accelerated approval. The companies will focus on the ongoing phase 3 IDeate-Lung02 trial, which has faced delays due to safety concerns. I-DXd is also being tested in other cancer types.
How this was made
The 30-second read
Why it matters
The withdrawal removes a near‑term catalyst, likely prompting short‑term price pressure for both companies and may affect sentiment toward similar ADC programs.
Market read
Regulatory setback for a high‑profile oncology ADC could influence biotech valuations and investor sentiment toward accelerated‑approval pipelines.
What to watch
The partial clinical hold on the phase‑3 trial could still affect timelines; safety concerns may limit future approval chances.
Background
The article reports the first public disclosure that Daiichi Sankyo and Merck have withdrawn their accelerated‑approval filing for the ADC ifinatamab deruxtecan in extensive‑stage small cell lung cancer after FDA feedback.
Ticker impact
Merck co‑developing I‑DXd withdrew its accelerated approval bid, eliminating a pipeline catalyst for the company.
likely pressure as investors reassess oncology growth expectations
The loss of a potential accelerated‑approval drug dampens near‑term pipeline momentum.
Market effects
ADC and lung‑cancer therapeutic sector loses a near‑term candidate, potentially weighing on peer biotech stocks.
Japanese and US biotech markets may see modest downside pressure.
Regulatory setback highlights FDA scrutiny of accelerated‑approval pathways globally.
Counterpoint
If the phase‑3 IDeate‑Lung02 trial shows strong results, the withdrawal may be a temporary setback with upside potential later.
Key entities
- CompanyDaiichi Sankyo Co Ltd
Japanese pharmaceutical firm co‑developing I‑DXd.
- CompanyMerck & Co Inc
U.S. pharmaceutical giant co‑developing I‑DXd.
