China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its zorifertinib, an oral tyrosine kinase inhibitor targeting epidermal growth factor receptor (EGFR) mutations (L858R and Exon 19Del), has been accepted for review by the Center for Drug Evaluation (CDE). Zorifertinib is indicated for the treatment of advanced EGFR-sensitive mutation non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastasis.
Clinical Data and EVEREST Study
The NDA filing is based on high-grade clinical data from the randomized, open-label, global multi-center Phase II/III EVEREST study. The study verified that zorifertinib effectively treats advanced NSCLC patients with EGFR-sensitive mutations associated with CNS metastasis. It demonstrated a significant reduction in the risk of disease progression or death, efficacy in treating metastatic lesions in the nervous system, and safety characteristics typical of EGFR-TKI drugs. The study also highlighted that subsequent drug resistance was primarily driven by T790M mutations.
Zorifertinib: Next-Generation EGFR-TKI
Zorifertinib is the only next-generation EGFR-TKI targeting EGFR gene-sensitive mutations, with a strong ability to penetrate the blood-brain barrier. As a substrate of non-blood-brain barrier efflux transporters P-gp and BCRP, zorifertinib is designed to effectively address EGFR gene exon 19 deletions or L858R mutations, positioning it as a potential breakthrough therapy for patients with advanced NSCLC and CNS metastasis.-Fineline Info & Tech
