Merck Withdraws BLA for Antibody-Drug Conjugate I-DXd in Small Cell Lung Cancer
Merck (MRK) has voluntarily withdrawn its Biologics License Application (BLA) for the antibody-drug conjugate ifinatamab deruxtecan (I-DXd) intended to treat extensive-stage small cell lung cancer. The company stated that clinical data did not meet regulatory requirements necessary for accelerated approval of this indication. The decision follows a review by Merck, which concluded that the available evidence was insufficient to support an application under the FDA's accelerated pathway. This move reflects ongoing challenges in developing effective treatments for aggressive cancers like small cell lung cancer and highlights the rigorous standards required for drug approvals. Merck has not ruled out future development of I-DXd but will reassess its strategy based on additional data or alternative indications.
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Topics: cancer treatment drug development regulatory approval