欧盟批准阿斯利康易瑞沙（Iressa）血液ctDNA伴随诊断

莺歌燕舞

2014年9月30日讯 /生物谷BIOON/ --阿斯利康（AstraZeneca）肿瘤学药物易瑞沙（Iressa，通用名：gefitinib，吉非替尼）近日获得了欧盟的好消息。欧洲药品管理局（EMA）人用医药产品委员会（CHMP）已建议批准Iressa标签II型变化更新，该标签更新，将使医生能够采用血液循环肿瘤细胞DNA（ctDNA）检测方法，评估EGFR突变状态，进而鉴别出最可能从Iressa治疗中受益的非小细胞肺癌（NSCLC）患者群体。

目前，穿刺活检（biopsy）是获得患者肿瘤样本的主要方法，以便确定肿瘤EGFR突变状态，否则患者将不能进行EGFR-TKI类药物治疗，如Iressa。ctDNA检测方法，是一种非侵入性诊断方法，利用一种高度敏感的技术，检测患者血液样本中ctDNA小片段中的EGFR突变状态，从而区分出能够从Iressa药物中受益的患者群体。

根据标签II型变化的性质，CHMP的积极意见，无需EMA的进一步批准。因此，Iressa标签更新将即刻生效，使Iressa成为欧盟首个携带此II型变化标签的药物，允许医生采用ctDNA检测来评估EGFR突变状态，将极大地改善临床非小细胞肺癌（NSCLC）患者EGFR突变状态的诊断和治疗。

Iressa是一种表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），能够阻断导至肿瘤生长的信号通路。EGFR是一种在许多类型肿瘤细胞上呈异常高水平表达的蛋白，尤其是非小细胞肺癌（NSLCL）。在欧盟，Iressa是EGFR突变阳性NSCLC的标准治疗药物，适用于伴有EGFR酪氨酸激酶激活型突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。因此，只有肿瘤EGFR突变阳性的患者群体适合Iressa治疗。

此前，阿斯利康已与德国QIAGEN（凯杰）签署合作协议，开发一种非侵入性ctDNA诊断试剂盒，作为易瑞沙（Iressa）的伴随诊断试剂盒，确定适合该药治疗的NSCLC患者群体。在IVIFUM（易瑞沙后续评估）研究中，该款ctDNA诊断试剂盒表现出了强大且可靠的EGFR突变状态鉴别能力。

关于易瑞沙（Iressa）：

易瑞沙（Iressa）是一种靶向性单药疗法，适用于EGFR突变阳性的晚期或转移性非小细胞肺癌（NSCLC）成人患者的治疗。Iressa通过阻断EGFR的酪氨酸激酶发挥作用，阻断涉及肿瘤生长和扩散的信号传导。在欧洲，约10-15%的非小细胞肺癌（NSCLC）携带EGFR突变，而在亚洲，这一比例高达30-40%。易瑞沙（Iressa）于2009年上市，目前已获全球89个国家批准。（生物谷Bioon.com）

英文原文：IRESSA receives CHMP positive opinion to include blood based diagnostic testing in European label

Friday, 26 September 2014

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update* to the European label for IRESSA? (gefitinib). The label update will help doctors to identify lung cancer patients - based on the specific genetic drivers of their tumour - who could benefit from treatment with IRESSA but are unable to provide a suitable tumour sample.

IRESSA is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) indicated for the first line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the EGFR tyrosine kinase. Therefore, only patients whose tumours are EGFR mutation positive are eligible to receive treatment. Tumour samples gained through biopsy are the primary method for determining a patient’s EGFR mutation status, without which patients are not eligible for treatment with an EGFR TKI such as IRESSA, which is the standard of care in Europe. However, up to 25 percent of patients with locally advanced or metastatic NSCLC do not have an available or evaluable tumour sample for this method of testing.

Following today’s CHMP opinion, IRESSA will be the first EGFR TKI in Europe to have a label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option. The update will take effect immediately and will be applicable in all 28 European Union member countries.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “At AstraZeneca, we are committed to developing targeted medicines that improve health outcomes for patients. Understanding the nature of an individual’s tumour and therefore which medicine is most likely to benefit them is vital if we are to transform the way cancer patients are treated. If doctors are unable to assess the mutation status of a tumour, then patients’ access to potentially life-changing medicines such as IRESSA becomes restricted. Today’s decision by the CHMP to endorse a label update for IRESSA is a significant step forward.”

AstraZeneca has pioneered the use of innovative blood-based diagnostic testing for solid tumours and recently announced a partnership with Qiagen to develop a ctDNA test as a companion diagnostic for IRESSA.

NOTES TO EDITORS

*The CHMP positive opinion to include blood based testing to determine EGFR mutation status in IRESSA’s European label can be implemented without further approval by the EMA due to the nature of the amendment, which is a Type-II variation.

About IRESSA

IRESSA is a targeted monotherapy for the first line treatment of patients with advanced or metastatic EGFR mutation positive non-small cell lung cancer (NSCLC). IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. EGFR mutations occur in approximately 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia.

IRESSA was launched in 2009 and is now approved in 89 countries worldwide