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FDA granted accelerated approval of ZEGFROVY (sunvozertinib) for adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy. Approval based on WU-KONG1B trial showing 46% ORR and 11.1-month median DoR; continued approval contingent on confirmatory trial. Product is now commercially available in the US as the only approved oral single-agent targeted therapy in this setting.
ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations Only approved oral, single agent, targeted therapy for these patients following platinum-based chemotherapy Launch expands AstraZeneca’s commitment to addressing substantial unmet need across the spectrum of EGFR-mutated lung cancer with a proven portfolio of medicines targeting EGFR mutations AstraZeneca today announced the US availability of ZEGFROVY ® (sunvozertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy. 1 The US Food and Drug Administration granted accelerated approval to ZEGFROVY based on results from the WU-KONG1B trial. 2 In the open-label, dose randomization clinical trial, ZEGFROVY demonstrated a confirmed overall response rate of 46% (n=85; 95% confidence interval [CI] 35, 57) and a median duration of response of 11.1 months in those responders (n=39; 9