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AstraZeneca: FDA application in lung cancer

( - AstraZeneca and its partner Daiichi Sankyo announce that the US FDA has agreed to review their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with treatment-experienced locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

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

In patients with non-squamous NSCLC, datopotamab deruxtecan showed a clinically significant benefit in PFS and a numerically favorable trend in overall survival (OS). The trial is ongoing and OS will be assessed in the final analysis.

Datopotamab deruxtecan has the potential to offer patients with previously treated advanced non-squamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy, AstraZeneca said.

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