Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR Exon20ins mutation, an indication for which the drug has previously earned BTD status in the United States.
Sunvozertinib was approved in China in August of the previous year 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 new designation marks the fourth BTD that Dizal has received for sunvozertinib in the context of EGFR exon20ins NSCLC, highlighting the drug’s potential to address a significant unmet medical need.- Flcube.com
