Dabrafenib突破性療法認(rèn)定的授予，是基于一項正在開展的II期研究的中期療效和安全性數(shù)據(jù)。該項研究在25例攜帶BRAF V600E突變、且既往接受過至少一次含鉑化療方案的NSCLC患者中開展，研究中將dabrafenib進行口服給藥。這些中期數(shù)據(jù)已提交至2013年美國臨床腫瘤學(xué)會年會。
肺癌是男性和女性中的第二大常見癌癥，是目前癌癥相關(guān)死亡的主要原因之一。腫瘤生物學(xué)中的最新進展已確定了肺癌相關(guān)的基因突變，如BRAF蛋白中的突變，這些突變能夠驅(qū)動非小細(xì)胞肺癌（NSCLC）中惡性細(xì)胞的生長和腫瘤的增殖。據(jù)估計，dabrafenib靶向的BRAF V600E突變，約占NSCLC病例的2.0%。
關(guān)于Tafinlar（dabrafenib）：
Tafinlar是葛蘭素史克開發(fā)的一種抗癌藥物，該藥已分別于2013年5月和9月獲FDA和EMA批準(zhǔn)，用于攜帶BRAF V600E突變的手術(shù)不可切除性黑色素瘤或轉(zhuǎn)移性黑色素瘤成人患者的治療。
dabrafenib為一種激酶抑制劑，靶向于BRAF蛋白，這是機體內(nèi)一個生物信號通路中的關(guān)鍵元件，該信號通路調(diào)節(jié)細(xì)胞的正常生長和死亡，包括皮膚細(xì)胞。
轉(zhuǎn)移性黑色素瘤中，約有一半攜帶BRAF突變，該異常突變能促使黑色素瘤生長和擴散。
英文原文：Tafinlar® receives FDA Breakthrough Therapy designation for non-small cell lung cancer with BRAF mutation
- Marks GSK’s fourth Breakthrough Therapy designation
Issued: Monday 13 January 2014, London UK
GlaxoSmithKline plc (LSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar® (dabrafenib) for treatment of patients with metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy. Dabrafenib is not approved or licensed anywhere in the world for use in this treatment setting.
The Breakthrough Therapy designation was based on interim efficacy and safety results from an ongoing Phase II study of dabrafenib administered orally to 25 patients who had NSCLC with the BRAF V600E mutation and who had received at least one previous course of chemotherapy. These interim results were presented at the 2013 American Society for Clinical Oncology Annual Meeting.
Lung cancer is the second most common cancer in both men and women and is by far the leading cause of cancer-related death worldwide. Recent advances in the understanding of tumour biology have identified genetic mutations, such as mutation in the BRAF protein, that can drive malignant cell growth and tumour proliferation in NSCLC. It is estimated that the BRAF V600E mutation targeted by dabrafenib is present in approximately 2.0%.[i], [ii] of patients with NSCLC.
