FDA accepts datopotamab deruxtecan BLA for review

The Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

Dato-DXd, an antibody drug conjugate (ADC), is being developed by UK pharm major AstraZeneca (LSE: AZN) and Japan’s Daiichi Sankyo’s (TYO: 4568) under a July 2020 agreement. The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for its regulatory decision is December 20. If approved, the drug could be the first TROP2-directed ADC for patients with lung cancer

The BLA is based on results from the pivotal TROPION-Lung01 Phase III trial in which datopotamab deruxtecan demonstrated a statistically-significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients with locally advanced or metastatic NSCLC treated with at least one prior line of therapy.