Therapy Areas: Oncology
AstraZeneca announces US acceptance of BLA for datopotamab deruxtecan to treat lung cancer
19 February 2024 -

Biopharmaceutical company AstraZeneca (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Monday that in collaboration with pharmaceutical company Daiichi Sankyo, its Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for treating adult patients with advanced nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The Prescription Drug User Fee Act date for regulatory decision is in Q4 2024.

AstraZeneca and Daiichi Sankyo are jointly developing datopotamab deruxtecan, a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC).

Based on TROPION-Lung01 Phase III trial results, datopotamab deruxtecan demonstrated a significant improvement in progression-free survival (PFS) compared to docetaxel, the current standard of care. Although interim overall survival (OS) results showed a favourable trend, they were not statistically significant at the data cut-off. Datopotamab deruxtecan is the first TROP2-directed antibody drug conjugate proposed for lung cancer treatment.

The drug's safety profile aligned with previous observations and results from TROPION-Lung01 were presented at the 2023 European Society for Medical Oncology Congress.

Datopotamab deruxtecan's parallel BLA for metastatic hormone receptor (HR)-positive, HER2-negative breast cancer is pending acceptance.

AstraZeneca's commitment to lung cancer treatment reflects its ambition to redefine cancer care globally, with a focus on innovation and patient outcomes. As a founding member of the Lung Ambition Alliance, the company aims to accelerate innovation and improve lung cancer treatment.