肺癌一线！「伏美替尼」新适应症拟纳入突破性疗法

Core Viewpoint - The article discusses the inclusion of a new indication for the drug Vomeletinib, which is intended for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations, as a breakthrough therapy [1][4]. Group 1: Drug Information - Vomeletinib is a third-generation EGFR-TKI that has previously been approved for two indications in China, targeting adult patients with EGFR mutations in NSCLC for second-line and first-line treatments [6]. - The new indication for Vomeletinib targets approximately 70 subtypes of EGFR PACC mutations, which account for about 12.5% of all EGFR mutation NSCLC patients, and currently, there are no approved drugs for this specific mutation in China [3][6]. Group 2: Clinical Research - The FURMO-002 study is the first prospective study globally to evaluate the efficacy and safety of Vomeletinib in treating NSCLC patients with EGFR PACC mutations [3][6]. - As of June 2025, the study reported an objective response rate (ORR) of 81.8% and a confirmed ORR of 68.2% for Vomeletinib at a dosage of 240 mg, with a disease control rate (DCR) of 100%, a median duration of response (DOR) of 14.6 months, and a median progression-free survival (PFS) of 16.0 months [7]. Group 3: Financial Performance - Vomeletinib is a major revenue source for the company, with sales increasing year-on-year. In 2024, the total revenue from Vomeletinib reached 3.506 billion yuan, representing a year-on-year growth of 77.27% [4][7]. - In the first half of 2025, Vomeletinib continued to show strong growth, achieving product sales revenue of 2.36 billion yuan, a nearly 51% increase compared to the previous year [7].