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Merck, Daiichi Sankyo Scrap FDA Application for Lung Cancer Drug

Reviewed by ClearTape · Source: Benzinga

Key takeaways

Merck and Daiichi Sankyo pulled their accelerated‑approval application for I‑DXd after the FDA deemed the data inadequate, but Phase 3 studies will proceed.
48.2% confirmed ORR in 137 patients
63 partial responses
54 stable disease cases

What happened

Merck & Co. Inc. (MRK) and Daiichi Sankyo voluntarily withdrew their U.S. Biologics License Application for the lung‑cancer drug ifinatamab deruxtecan (I‑DXd) after the FDA said the data did not meet accelerated‑approval criteria.

Why it matters

The withdrawal signals that the FDA found the evidence insufficient for accelerated approval, potentially delaying a new treatment option for extensive‑stage small cell lung cancer (ES‑SCLC) patients and affecting the companies’ development timelines and investor expectations.

Short-term and longer-term

Short-term. Merck shares dipped 0.08% to $148.66 after the withdrawal announcement.

Longer-term. The withdrawal indicates a regulatory hurdle that could delay the drug’s market entry and affect long‑term revenue projections.

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