Posted by Michael Wonder on 08 Jan 2025
US FDA granted priority review to Dizal's sunvozertinib new drug application
7 January 2025 - Sunvozertinib's new drug application was submitted based on the multinational pivotal WU-KONG1 Part B study, the results of which were presented at the 2024 ASCO Annual Meeting.
Dizal announced that the US FDA has accepted and granted priority review to the company's new drug application for sunvozertinib, an oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell lung cancer patients with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
