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Daiichi Sankyo and Merck Withdraw BLA for Small-Cell Lung Cancer Treatment
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have withdrawn their Biologics License Application (BLA) for ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC), to treat adults with extensive-stage small-cell lung cancer whose disease progressed on or after platinum-based chemotherapy.
The companies voluntarily withdrew the BLA, which was under priority review by the FDA. The reason for the withdrawal is not specified in the announcement.
ifinatamab deruxtecan, also known as i-dxd, was being developed to target B7-H3, a protein often overexpressed in various types of cancer, including small-cell lung cancer.