Posted by Michael Wonder on 07 Apr 2024
FDA grants breakthrough therapy designation to sunvozertinib for the first-line treatment of patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harbouring epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
This breakthrough therapy designation approval was based on results from the global multi-centre Phase I/II study (WU-KONG1). At 2023 ESMO, Dizal reported main study results, showing sunvozertinib as a single agent with confirmed objective response rate of 78.6% and a median progression-free survival of 12.4 months.
