Merck and Daiichi Sankyo Withdrew Cancer Drug Bid
The companies pulled their FDA application for the lung cancer drug ifinatamab deruxtecan after data feedback.
Updated on Sept. 26, 2026 in Cancer
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Merck and Daiichi Sankyo have voluntarily withdrawn their biologics license application for the lung cancer drug ifinatamab deruxtecan. The decision followed regulatory guidance indicating that the provided clinical data package failed to satisfy requirements for accelerated approval.
Why it matters
The FDA determined that results from the Phase II IDeate-Lung01 trial were insufficient to support an accelerated approval path for the proposed indication. This withdrawal forces the partners to reevaluate their development strategy for the drug within the United States market.
The drug showed a confirmed objective response rate of 48.2% among 137 patients in the IDeate-Lung01 trial. Regulators concluded this data package did not meet the necessary criteria for accelerated approval.
The players
Merck
This global biopharmaceutical company develops and manufactures a wide range of innovative medicines and vaccines.
Daiichi Sankyo
This Japanese pharmaceutical company specializes in the development of oncology treatments and antibody-drug conjugates.
FDA
The Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety and efficacy of medical products.
The details
The companies submitted the biologics license application seeking an accelerated path to market for the antibody-drug conjugate. Following FDA feedback regarding data insufficiency, the partners opted to withdraw the submission while maintaining other active Phase III development programs.
Timeline
December 2025: Enrollment in the IDeate-Lung02 trial was paused due to reports of interstitial lung disease deaths.
January 2026: The clinical hold on the IDeate-Lung02 trial was officially lifted.
September 25, 2026: Merck and Daiichi Sankyo formally withdrew their FDA submission.
The Big Picture
This development follows the rigorous standards of the FDA's Accelerated Approval Program. The withdrawal reflects the agency's current mandate to hold developers to strict clinical evidentiary requirements before allowing early patient access to new cancer therapies.
The withdrawal means this specific treatment will not be available for the proposed indication in the near term. Patients currently seeking therapeutic options should consult with their oncologists regarding clinical trials and standard-of-care treatments.
The takeaway
Drug developers often face regulatory hurdles when attempting to navigate accelerated pathways with Phase II data. Future approval for this treatment now depends on the success of the ongoing IDeate-Lung02 study.
Further reading
For more information on the evolving landscape of oncology treatments, visit the Cancer section.
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