The FDA has expanded AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Datroway to include treatment for locally advanced or metastatic epidermal growth factor receptor mutated non-small cell lung cancer patients previously treated with EGFR-targeted therapies and chemotherapy. This accelerated approval, supported by phase 2 and 3 data demonstrating significant tumor response rates, makes Datroway the first TROP2-directed drug approved for NSCLC in the US. The label extension closely follows its earlier nod for HR-positive breast cancer. Both companies also await results from ongoing trials testing Datroway and Imfinzi combinations in frontline NSCLC, underscoring its clinical development importance.