Roche Drug Scores Label Expansion for Earlier Use in Lung Cancer

MedCity News | 2024-04-20 | 翻译由动脉网AI生成，点击反馈

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A Roche cancer drug that treats lung cancer with a certain genetic signature now has an additional FDA approval that expands the applications of the blockbuster product.

罗氏公司的一种具有某种基因特征的治疗肺癌的抗癌药物现在获得了FDA的额外批准，扩大了该重磅炸弹产品的应用范围。

The drug, Alecensa, is already approved as a first- and second-line treatment for non-small cell lung cancer (NSCLC). The latest approval for the drug permits its use as an adjuvant, a therapy used after the primary cancer treatment (usually surgery) to kill any remaining cancer cells and to reduce the risk of the disease’s return..

Alecensa药物已被批准作为非小细胞肺癌（NSCLC）的一线和二线治疗药物。该药物的最新批准允许将其用作佐剂，这是一种在原发性癌症治疗（通常是手术）后用于杀死任何残留癌细胞并降低疾病复发风险的疗法。。

Alecensa is a tyrosine kinase inhibitor, a type of drug that block enzymes that drive cancer growth. The Roche drug specifically blocks enzymes that stem from the mutated ALK gene. An estimated 5% of NSCLC cases are ALK positive. Before treatment with Alecensa, the ALK mutation must be detected by a companion diagnostic..

Alecensa是一种酪氨酸激酶抑制剂，一种阻断驱动癌症生长的酶的药物。罗氏药物特异性阻断源自突变ALK基因的酶。估计有5%的NSCLC病例是ALK阳性的。在用Alecensa治疗之前，必须通过伴随诊断检测ALK突变。。

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The new approval for Alecensa is based on the results of an open-label Phase 3 study that enrolled patients with ALK-positive NSCLC that was surgically removed. For adjuvant therapy, a total of 257 patients were randomly assigned to receive either the Roche drug twice daily or platinum-based chemotherapy.

Alecensa的新批准是基于一项开放标签的3期研究的结果，该研究招募了通过手术切除的ALK阳性NSCLC患者。对于辅助治疗，共有257名患者被随机分配接受罗氏药物每日两次或铂类化疗。

The main goal was to measure disease-free survival..

主要目标是衡量无病生存率。。

Adjuvant treatment with Alecensa reduced the risk of disease recurrence or death by 76% compared to the chemotherapy arm, Roche reported. The drug’s safety profile was consistent with previous tests. Warnings and precautions included on Alecensa’s label include liver toxicity, interstitial lung disease, and kidney impairment.

罗氏报道，与化疗组相比，Alecensa辅助治疗可将疾病复发或死亡风险降低76%。该药物的安全性与之前的测试一致。Alecensa标签上的警告和注意事项包括肝毒性，间质性肺病和肾功能损害。

The trial results were presented last fall during the European Society for Medical Oncology annual meeting and published earlier this month in the New England Journal of Medicine..

该试验结果于去年秋天在欧洲肿瘤医学会年会上公布，并于本月早些时候在《新英格兰医学杂志》上发表。。

Lung cancer often metastasizes to the brain. Roche noted that an exploratory analysis of the Phase 3 data showed an improvement in central nervous system disease-free survival. The drug’s latest approval gives patients an earlier treatment option, according to Ken Culver, director of research and clinical affairs at ALK Positive, a patient group for ALK-positive patients..

肺癌常转移到大脑。罗氏指出，对第三阶段数据的探索性分析显示，中枢神经系统无病生存率有所改善。ALK阳性患者研究和临床事务主任肯·卡尔弗（KenCulver）表示，该药物的最新批准为患者提供了更早的治疗选择。。

“The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy,” Culver said in a prepared statement. “These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC.”.

Culver在一份准备好的声明中说：“Alecensa的批准标志着新诊断为早期ALK阳性肺癌的人的关键时刻，到目前为止，他们还无法接受ALK特异性治疗。”。“这些患者通常被诊断为年龄较小，与其他类型的非小细胞肺癌患者相比，经常面临复发和发生脑转移的风险更高。”。