
10月15日 - 欧洲药品管理局委员会周四建议欧盟批准革命药业针对转移性胰腺癌成人的药物,这可能为该地区患者提供一种针对疗效有限疾病的新选择。
Oct 15 - A European Medicines Agency committee on Thursday recommended EU approval of Revolution Medicines' drug for adults with metastatic pancreatic cancer, potentially offering patients in the bloc a new option for a disease with limited effective therapies.
这种每日一次口服药物Rasonque,化学名称为达拉克斯利布,于8月在美国通过加速审评程序获批,用于治疗最致命的癌症形式之一,其作用机制是阻断可能驱动癌细胞生长的RAS蛋白。
The once-daily oral drug Rasonque, chemically known as daraxonrasib, was approved in the US in August under an expedited review process for one of the deadliest forms of cancer, and works by blocking RAS proteins that can drive cancer-cell growth.
委员会的支持使革命药业的潜在畅销药更接近在欧洲上市,欧盟委员会将作出最终决定。
The committee's endorsement moves Revolution Medicines' potential blockbuster closer to launch in Europe, with the European Commission set to make the final call.
革命药业首席执行官马克·戈德史密斯在一份声明中表示,公司期待欧盟委员会的决定,因为它将继续“在全球与监管当局合作,以争取更多批准并扩大Rasonque的可及性”。该药物适用于既往治疗后病情恶化的成人患者,在美国30天供应量的价格为39,800美元。专家们赞誉它为潜在的挽救生命的治疗,指出其疗效以及提升 aggressive 癌症患者生存率的前景。
Revolution Medicines CEO Mark Goldsmith said in a statement the company looks forward to the European Commission's decision as it continues "to work with regulatory authorities around the world to pursue additional approvals and broaden access to Rasonque." The drug, meant for adults whose disease has worsened after prior treatment, is priced at $39,800 in the US for a 30-day supply. Experts have hailed it as a potentially lifesaving treatment, pointing to its efficacy and the prospect of better survival rates for patients with the aggressive cancer.
胰腺癌常在已扩散时才被诊断出来,早期治疗失效后选择甚少。化疗仍是该病的主要治疗手段。
Pancreatic cancer is often diagnosed after it has spread, with few options once earlier treatment stops working. Chemotherapy remains the primary treatment for the disease.
该药物在美国在重大试验结果公布后需求强劲,促使FDA通过其同情用药计划为患有严重或危及生命疾病的患者提供用药途径。
The drug drew strong demand in the US after major trial results, prompting the FDA to grant access through its compassionate use program for patients with serious or life-threatening illnesses.