
Revolution Medicines公司周四发布声明称,其研发的胰腺癌治疗药物获得了欧盟一个重要咨询委员会的认可,这标志着该能够延长患者生命的药物有望在由27个成员国组成的欧盟地区投入使用。
Medicines Inc.’s pancreatic cancer drug won the backing of a key European Union advisory panel, the company said in a statement Thursday, moving the life-extending medicine closer to reaching patients in the 27-nation bloc.
这种名为达拉索拉西布的治疗药物于今年8月在美国获批上市,堪称近年来胰腺癌治疗领域的一项重大突破。在一项三期临床试验中,该药物使患有侵袭性胰腺癌的患者平均生存期几乎延长了一倍。
The treatment, daraxonrasib, was approved in the US in August and is one of the more significant breakthroughs in pancreatic cancer in years. In a final-stage trial, it nearly doubled the usual survival time for patients with an aggressive form of the disease.
目前,在欧洲药品管理局的人用药品委员会给出批准建议后,欧盟委员会也将在未来数月内作出最终决定。
Now that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval, the European Commission will make a final decision in the coming months.
该药物是首批能够广泛且有效作用于RAS蛋白的疗法之一。RAS蛋白与肿瘤生长密切相关,大多数胰腺癌患者的该蛋白均存在变异。多年来,研究人员一直致力于研发可针对各种变异形式RAS蛋白的药物,直到Revolution Medicines公司的科研团队开发出一种创新的“分子粘合剂”,成功抑制了这种危险蛋白的活性。
The medicine is one of the first to broadly and successfully target RAS, a protein tied to tumor growth that’s mutated in most pancreatic cancers. Researchers struggled for years to design drugs that worked against all forms of it until scientists at Revolution Medicines crafted an innovative “molecular glue” that essentially smothered the dangerous protein.
该药物在美国以Rasonque为商品名销售,年治疗费用超过47.5万美元,属于价格极为昂贵的抗癌药物之一。据彭博社对分析师的调查显示,该药物未来有望实现全球年销售额超90亿美元的成绩。
The drug is sold under the name Rasonque in the US at a list price of more than $475,000 a year, making it one of the more expensive cancer medicines. It could eventually bringing in more than $9 billion in worldwide annual sales, according to a survey of analysts by Bloomberg.
需要指出的是,该药物无法彻底治愈胰腺癌,且患者最终会产生耐药性。常见的副作用包括皮疹和口腔溃疡。
The drug isn’t a cure and resistance eventually develops. Side effects include rash and mouth sores.