AstraZeneca's EGFR inhibitor Tagrisso has become the first drug in the class to be approved in the EU as a treatment for a specific form of locally advanced, unresectable non-small cell lung cancer (NSCLC).The European Commission has approved Tagrisso (osimertinib) for this indication in patients with stage 3 tumours that have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT).The highly anticipated approval comes on the back of the LAURA trial, which was a highlight of this year's ASCO congress and has been tipped to become an important new indication for Tagrisso, currently AZ's second best-selling drug with sales of almost $4.9 billion in the first nine months of this year.The results showed that Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, with progression-free survival (PFS) of 39.1 months and 5.6 months, respectively.At ASCO, the stellar PFS data sparked speculation that Tagrisso will become the standard of care in this type of early lung cancer, which until now had no targeted therapies approved in the EU.

阿斯利康（AstraZeneca）的EGFR抑制剂塔格里索（Tagrisso）已成为该类药物中第一种被欧盟批准用于治疗特定形式的局部晚期不可切除非小细胞肺癌（NSCLC）的药物。欧盟委员会已批准Tagrisso（osimertinib）用于具有EGFR外显子19缺失或外显子21（L858R）替代突变且在铂类放化疗（CRT）期间或之后疾病未进展的3期肿瘤患者。备受期待的批准是在LAURA试验的基础上进行的，这是今年ASCO大会的一个亮点，并有望成为Tagrisso的重要新适应症，Tagrisso目前是AZ第二畅销药物，今年前9个月销售额近49亿美元。结果显示，与安慰剂相比，Tagrisso将疾病进展或死亡的风险降低了84%，无进展生存期（PFS）分别为39.1个月和5.6个月。在ASCO，stellar PFS的数据引发了人们的猜测，塔格里索将成为这种早期肺癌的标准治疗方法，到目前为止，欧盟尚未批准针对性治疗。

The drug was approved in the US for the same indication in September.AZ has previously said that the LAURA results, combined with the ADAURA study of Tagrisso as adjuvant treatment of EGFR-positive NSCLC which was a highlight of the 2023 ASCO conference, show that EGFR inhibitors can have a dramatic impact in early-stage lung cancer and should be used as early as possible in the treatment pathway.That's important for AZ, as Tagrisso is starting to face the threat of competition from other EGFR drugs, including Johnson & Johnson's fast-growing EGFRxMET bispecific antibody Rybrevant (amivantamab), which has pr.

该药物于9月份在美国被批准用于相同的适应症。AZ之前曾表示，LAURA的研究结果，结合Tagrisso的ADAURA研究作为EGFR阳性NSCLC的辅助治疗，这是2023年ASCO会议的一个亮点，表明EGFR抑制剂可以对早期肺癌产生巨大影响，应该尽早在治疗途径中使用。这对AZ来说很重要，因为塔格里索开始面临来自其他EGFR药物的竞争威胁，包括强生公司快速增长的EGFRxMET双特异性抗体Rybrevant（amivantamab），它具有pr。