勃林格殷格翰（Boehringer Ingelheim）宣布，抗癌药物afatinib获欧盟委员会（EC）批准，作为一种单药疗法，用于携带激活性EGFR突变的局部晚期或转移性非小细胞肺癌（NSCLC）初治成人患者的治疗。在欧洲，afatinib将以品牌名Giotrif上市。

Giotrif的获批，是基于关键性LUX-Lung 3临床试验，这是在携带EGFR突变阳性肺癌患者中开展的迄今为止最大规模的的全球性III期试验，研究结果证实了afatinib在携带EGFR突变的IIIb或IV阶段肺腺癌患者中相对于业界最佳化疗药物（培美曲塞和顺铂）的优越性。

试验中，将afatinib作为一线治疗药物对患者进行了治疗，afatinib患者组疾病无进展生存期（PFS）为11.1个月，而化疗组（培美曲塞/顺铂）PFS为6.9个月。此外，针对携带2种最常见的EGFR突变（del19和L858R）的NSCLC，afatinib患者组PFS达13.6个月，而对照组仅为6.9个月。

Afatinib治疗组疾病进展延迟，患者大都经历了呼吸困难、气短、咳嗽、胸痛等症状的改善，Afatinib也显着延迟了这些症状的恶化。

Afatinib是勃林格殷格翰首个肿瘤学药物，是首个不可逆ErbB家族阻断剂，该药积极的临床证据，加上全新的作用模式，使其成为一种杰出的治疗选择，有望为肺癌患者提供其急需的临床需求。

Afatinib于2013年7月15日获得了FDA的批准，以商品名Gilotrif上市，作为一种口服的、新的一线治疗药物，用于经由FDA批准的试剂盒证实肿瘤表皮生长因子受体（EGFR）19号外显子缺失或21号外显子突变（L858R）的转移性非小细胞肺癌（NSCLC）患者的治疗。

目前，勃林格殷格翰也已向亚洲及其他国家监管当局提交了afatinib的监管审批，用于EGFR突变阳性的局部晚期和转移性NSCLC的治疗。（生物谷Bioon.com）

英文原文：GIOTRIF(afatinib) approved in Europe for patients with EGFR mutation positive lung cancer

INGELHEIM, Germany--(BUSINESSWIRE)-- For non U.S. Media Only

Boehringer Ingelheim announced today that the European Commission has granted marketing authorisation for afatinib monotherapy, for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). Afatinib will be marketed in Europe under the brand name GIOTRIF®.

“We are delighted with the decision by the European Commission. We hope this will be the first of many registrations for drugs from our in-house oncology research program,” commented Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The approval of afatinib in Europe reinforces our commitment to bringing the right treatments to the right patients. This is a significant step towards meeting the substantial unmet need in lung cancer treatment.”

Lung cancer is one of the most common forms of cancer, accounting for 1.6 million new cases each year.2 It is the most deadly; more people die of lung cancer than of colon, breast and prostate cancers combined.3 In Europe alone, lung cancer is responsible for almost 270,000 deaths each year.4 Although incidence rates are higher in men than women it has been suggested that, by 2015, lung cancer will overtake breast cancer as the biggest cause of female cancer death in Europe.4

Because lung cancer is more than one disease, distinct subtypes can be characterised by receptors that are frequently altered or overexpressed in cancer cells. One such molecular marker is EGFR (a member of the ErbB Family of receptors). The prevalence of tumours harbouring EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients.5

In clinical trials, afatinib has been shown to offer patients with this type of lung cancer a significant delay in tumour progression, coupled with improvements in their lung cancer related symptoms (e.g. shortness of breath, cough and chest pain) and quality of life.1,6 Therefore, early mutation testing for EGFR status is a crucial step in the treatment-decision pathway, to give patients the opportunity to receive the appropriate personalised therapy from the start.

“Its unique mode of action allows afatinib to block EGFR and other members of the ErbB Family of receptors that play a key role in the growth and spread of cancers associated with a high mortality such as lung cancer,” said Dr. Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, London and clinical investigator in the LUX-Lung 3 trial. “Clinical data demonstrates afatinib’s efficacy in delaying tumour growth and improving lung cancer related symptoms, making it an important addition to our treatment options in Europe.”

Following recent approvals in the U.S., Taiwan and Mexico, European Union approval of afatinib is based on data from the pivotal LUX-Lung 3 trial and other Phase III and Phase II lung cancer studies. Data from Phase III LUX-Lung 3 trial have shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/cisplatin. In addition, a subgroup analysis has shown that NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib lived for well over a year without tumour progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.1

The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhoea (14%), rash (16%), and inflammation of the nail bed (paronychia) (11%). The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy). 1% of patients in the afatinib arm discontinued due to drug-related diarrhoea.1

* In the EU, Taiwan and Mexico, afatinib is approved under the brand name GIOTRIF®, and in the U.S. under the brand name GILOTRIFTM for use in patients with distinct types of NSCLC. Afatinib is under regulatory review by health authorities in Asia and other countries.