Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for advanced non-small cell lung cancer (NSCLC) patients with EGFR Exon20ins mutation.
Last August, sunvozertinib was approved in China for the treatment of locally advanced or metastatic NSCLC with EGFR Exon20ins mutation in patients who have been previously treated with platinum chemotherapy or are intolerant to platinum. This approval made sunvozertinib the first and only Category 1 drug developed domestically in China for this specific indication.
The regulatory WU-KONG6 study conducted in China demonstrated sunvozertinib’s high efficacy and safety in treating advanced NSCLC with EGFR Exon20ins mutation, potentially positioning it as a best-in-class therapy. The study’s results have been instrumental in highlighting the drug’s potential to significantly improve outcomes for patients with this mutation.
The receipt of BTD from the FDA is a significant milestone for Dizal Pharmaceutical, reflecting the global recognition of the company’s commitment to innovation in oncology. It underscores the potential impact of sunvozertinib on the treatment landscape for patients with EGFR Exon20ins mutation-positive NSCLC worldwide.- Flcube.com
