The FDA has issued a partial clinical hold on the I-DXd trial for small cell lung cancer following unexpected patient deaths.
The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on a trial conducted by Merck and Daiichi Sankyo, investigating the antibody-drug conjugate (ADC) ifinatamab deruxtecan, also known as I-DXd, in patients with small cell lung cancer. This decision follows the observation of a “higher than anticipated” incidence of patient deaths during the study. Source.
Regulatory Action
The FDA’s partial hold means that no new patients can be enrolled in the trial until further notice. However, patients currently participating in the study may continue to receive treatment after being re-consented. The regulatory body has requested additional data to better understand the safety profile of I-DXd.
Clinical Context
Small cell lung cancer is an aggressive form of lung cancer characterized by rapid growth and early metastasis. Treatment options are limited, and new therapies are urgently needed. Antibody-drug conjugates like I-DXd are designed to deliver cytotoxic agents directly to cancer cells, potentially improving efficacy while minimizing systemic exposure.
Next Steps
Merck and Daiichi Sankyo are expected to work closely with the FDA to address the agency’s concerns and provide the necessary data. The companies aim to resume patient enrollment once safety issues are resolved. For more insights into regulatory actions and clinical trials, visit our insights hub.