诺诚健华宣布中国首款自主研发的新一代TRK抑制剂获批上市

Core Viewpoint - The approval of the new generation TRK inhibitor, Iruvotnib (Zolacretinib, ICP-723), by the National Medical Products Administration (NMPA) in China marks a significant milestone as it is the first domestically developed TRK inhibitor approved for treating adult and adolescent patients with NTRK fusion gene-positive solid tumors [1] Group 1: Product Approval - The NMPA has granted approval for Iruvotnib, a new generation TRK inhibitor developed by the company [1] - This approval is specifically for the treatment of adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] Group 2: Clinical Trial Results - In pivotal registration clinical trials, Iruvotnib demonstrated exceptional efficacy and safety as a broad-spectrum anti-cancer drug for patients with NTRK fusion-positive solid tumors [1] - The overall response rate (ORR) was reported at 89.1%, with a disease control rate (DCR) of 96.4% [1] - The 24-month progression-free survival (PFS) rate was 77.4%, and the overall survival (OS) rate at 24 months was 90.8% [1] Group 3: Administration Convenience - Iruvotnib is administered orally once daily, with a dosage of two tablets per administration, providing significant convenience for patients [1]