AstraZeneca PLC announced that the FDA accepted its Biologics License Application for datopotamab deruxtecan, targeting advanced nonsquamous non-small cell lung cancer, based on the TROPION-Lung01 Phase III trial results on February 19, 2024. If approved, this drug could become the first TROP2-directed antibody drug conjugate for patients previously treated with systemic therapies. The FDA decision is expected in Q4 2024.