林业发展局为先进的HER2变型肺癌核准了Sevabertinib,显示试验反应率很高。 The FDA approved sevabertinib for advanced HER2-mutated lung cancer, showing strong response rates in trials.

美国食品和药物管理局批准了sevabertinib (Hyrnuo) 用于先前治疗后,治疗 HER2 激素激酶域突变导致的晚期非状非小细胞肺癌 (NSCLC) 的成年人. The FDA has approved sevabertinib (Hyrnuo) for adults with advanced nonsquamous non-small cell lung cancer (NSCLC) driven by HER2 tyrosine kinase domain mutations, following prior therapy. 批准的依据是SOHO-01试验,显示在以前未接受HER2定向治疗的病人中,总体答复率为71%,平均答复期为9.2个月;在以前接受治疗的病人中,38%的答复率为38%,平均答复期为7.0个月。 Approval is based on the SOHO-01 trial, showing a 71% overall response rate and 9.2-month median response duration in patients not previously treated with HER2-targeted therapy, and a 38% response rate with a 7.0-month median duration in those previously treated. Oncomine Dx目标测试被核准为同伴诊断。 The Oncomine Dx Target Test is approved as a companion diagnostic. 常见副作用包括腹泻、皮疹和耳语,没有间歇性肺病病例的报告。 Common side effects include diarrhea, rash, and paronychia, with no cases of interstitial lung disease reported. 每天与食物一起服用两次该药物。 The drug is taken twice daily with food. 目前正在进行第3阶段的试验,以评价其作为一线治疗手段的使用情况。 A phase 3 trial is ongoing to evaluate its use as first-line treatment.