First ‘Breakthrough’ designation for datopotamab deruxtecan

Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

The antibody drug conjugate (ADC) was discovered by Japan’s Daiichi Sankyo (TYO: 4568) and is being jointly developed with UK pharma major AstraZeneca (LSE: AZN), under a deal that could potentially earn the Japanese drugmaker $7 billion.

The FDA granted this BTD based on data from the TROPION-Lung05 Phase II trial with supporting data from the TROPION-Lung01 Phase III trial. Results from a pooled analysis of patients with previously treated EGFRm NSCLC in these studies were presented this month at the European Society of Medical Oncology (ESMO) Asia 2024 Congress. This is the first BTD for datopotamab deruxtecan.