Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an oral session at the 2024 ASCO Annual Meeting Sunvozertinib is the world's first and only oral drug approved for NSCLC patients with EGFR exon20ins SHANGHAI , Nov. 8, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today the submission of a New Drug Application (NDA) to the U.S.

Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Previously, sunvozertinib received accelerated approval in China , making it the world's first and only oral drug for NSCLC patients with EGFR exon20ins. It has also been granted Breakthrough Therapy Designations (BTDs) by both the U.

S. FDA and the China Center for Drug Evaluation (CDE) for treating EGFR exon20ins NSCLC. The submission is supported by results from the WU-KONG1 Part B study, a multinational pivotal study investigating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients from Asia , Europe , North America , and South America .

Sunvozertinib met the primary endpoint by demon.