AstraZeneca announced the U.S. availability of ZEGFROVY® (sunvozertinib) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy. It is the only approved oral, single-agent targeted therapy for these patients.

The FDA granted accelerated approval based on the WU-KONG1B trial, which showed a confirmed overall response rate of 46%.

The launch addresses an unmet need: patients with this form of lung cancer have historically had limited targeted treatment options and poor prognoses. It also expands AstraZeneca’s portfolio of medicines targeting EGFR-mutated lung cancer.