AstraZeneca seeks FDA nod for HUTCHMED lung-cancer drug combo

HUTCHMED said Tuesday that AstraZeneca has filed with the U.S. Food and Drug Administration for approval of the ORPATHYS–TAGRISSO combination to treat patients with advanced lung cancer.

The companies said the combination extended progression-free survival and improved overall survival compared with chemotherapy in patients whose cancer progressed after prior EGFR-targeted treatment. EGFR, or epidermal growth factor receptor, is a protein on cell surfaces that helps cells grow and divide; mutations in the pathway drive a significant share of non-small-cell lung cancers, making later-line options after resistance a major clinical need.

ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. The therapy is already approved in China based on a separate Phase III study. The U.S. application puts the combination into a crowded late-stage oncology review queue as regulators weigh new choices for patients who have exhausted first-line targeted drugs and face limited alternatives beyond chemotherapy.