Home / Health / Cancer Drug Faces Setback in US Review
Cancer Drug Faces Setback in US Review
26 Sep
Summary
- Companies voluntarily withdrew US application for lung cancer therapy.
- FDA determined study data did not meet requirements for early approval.
- Drug was for patients with advanced small cell lung cancer.
Merck and Daiichi Sankyo announced on Friday that they have voluntarily withdrawn their application for accelerated approval in the United States for their experimental lung cancer treatment, ifinatamab deruxtecan. This action stems from recent discussions with the US Food and Drug Administration.
The regulatory agency determined that the data provided from a mid-stage clinical study did not satisfy the prerequisites for granting an early approval. The therapy was under review for adults diagnosed with extensive-stage small cell lung cancer.
Specifically, the drug was being considered for patients whose disease had worsened despite undergoing standard chemotherapy treatments.
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