Dizal's Sunvozertinib Receives Breakthrough Therapy Designation for First-Line NSCLC Treatment

Dizal, a biopharmaceutical company dedicated to the development of novel treatments for cancer and immunological diseases, has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for sunvozertinib. This designation is for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), who have not received prior systemic therapies.

Publish Date: 13-10-2024 Source: Dizal Pharma

Advanced metastatic NSCLC has shown a significant increase in survival rates with chemotherapy compared to best supportive care alone. Subsequent advancements included improved response rates with third-generation agents such as paclitaxel, docetaxel, vinorelbine, and gemcitabine, surpassing the efficacy of second-generation treatments like ifosfamide, mitomycin, and vindesine alongside standard platinum chemotherapy in doublet regimens. Current standard practice in treating metastatic NSCLC involves targeting anaplastic lymphoma kinase (ALK) with tyrosine kinase inhibitors (TKIs), particularly for ALK-positive patients confirmed through standard FISH (Fluorescence in situ hybridization) technique or for ROS1 positive patients. Alectinib has emerged as the preferred first-line agent due to its superior progression-free survival (PFS) demonstrated in direct comparison with crizotinib. The treatment landscape for advanced NSCLC has become increasingly complex with the advent of newer chemotherapy options, targeted therapies, and immunotherapy.

However, the current Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Trastuzumab Deruxtecan, Furmonertinib, HS-10365, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Advanced or Metastatic Non-Small-Cell Lung Cancer treatment. The key companies in the advanced development stage are AstraZeneca, ArriVent BioPharma, Inc., Jiangsu Hansoh Pharmaceutical Co., Ltd., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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