GSK has won FDA approval for Jideytro, a drug at the heart of its $10.6 billion acquisition of Nuvalent earlier this year – as a treatment for a form of lung cancer.

葛兰素史克（GSK）已获美国食品药品监督管理局（FDA）批准，将Jideytro作为一种肺癌治疗方案。该药物是今年早些时候葛兰素史克以106亿美元收购Nuvalent交易的核心资产。

ROS1 inhibitor Jideytro (zidesamtinib) has been cleared by the US regulator as a second-line or later therapy for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have already been treated with another drug in the class.

ROS1抑制剂Jideytro（zidesamtinib）已获美国监管机构批准，作为局部晚期或转移性ROS1阳性非小细胞肺癌（NSCLC）成人患者的二线或后线治疗药物，适用于此前已接受过同类药物治疗的患者。

The drug has been specifically designed to work in ROS1-positive tumours that have developed resistance mutations, reducing the effectiveness of other drugs in the class like Pfizer's first-to-market Xalkori (crizotinib), Roche's Rozlytrek (entrectinib), and Bristol Myers Squibb's Augtyro (repotrectinib)..

该药物专为在已产生耐药突变的ROS1阳性肿瘤中发挥作用而设计，这些耐药突变降低了同类其他药物的疗效，如辉瑞公司率先上市的Xalkori（克唑替尼）、罗氏公司的Rozlytrek（恩曲替尼）以及百时美施贵宝公司的Augtyro（瑞波替尼）。

Its closest rival is arguably Nuvation's

其最接近的竞争对手可以说是 Nuvation 的

Ibtrozi

伊布特罗齐

(taletrectinib), which was approved by the FDA last year for ROS1-positive NSCLC, including first-line use, and has also been billed as a next-generation drug that can tackle tumours with resistance mutations.

（塔雷替尼）于去年获得美国食品药品监督管理局（FDA）批准，用于治疗ROS1阳性非小细胞肺癌（NSCLC），包括一线治疗，并被誉为能够应对具有耐药突变的肿瘤的下一代药物。

The FDA approval of Jideytro comes on the back of the phase 1/2 ARROS-1 trial, in which Jideytro achieved an objective response rate (ORR) of 44%, with 69% of patients still responding to the treatment after 12 months follow-up. The drug was effective in patients with ROS1 mutations, as well as those whose cancer had spread to the brain..

Jideytro 获得美国食品药品监督管理局（FDA）批准，是基于一项1/2期ARROS-1试验的结果。在该试验中，Jideytro的客观缓解率（ORR）达到44%，且在12个月的随访后仍有69%的患者对治疗持续响应。该药物对携带ROS1突变的患者以及癌症已发生脑转移的患者均显示出疗效。

'Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients,' said Alexander Drilon of Memorial Sloan Kettering Cancer Centre in the US, one of the trial investigators.

“尽管治疗取得了进展，但耐药突变、脑部疾病进展以及治疗相关的不良事件继续给患者带来挑战。”美国纪念斯隆-凯特琳癌症中心的亚历山大·德里隆（Alexander Drilon）表示，他是该试验的研究者之一。

'The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease.'

“在ARROS-1中观察到的反应，包括在接受过大量预处理的患者中的反应，代表了这种疾病患者的重要进展。”

GSK's lung cancer pathfinder product

葛兰素史克的肺癌探路者产品

Jideytro is GSK's first lung cancer therapy, and one of three for the disease added by the UK-headquartered pharma group through the

Jideytro 是葛兰素史克（GSK）的首款肺癌疗法，也是这家总部位于英国的制药集团针对该疾病增加的三种疗法之一。

takeover of Nuvalent

收购 Nuvalent

, which was announced in June and closed last week.

，该活动于六月宣布，并于上周结束。

ALK inhibitor called neladalkib is also under review at the FDA for pre-treated, advanced-stage ALK-positive NSCLC, with a decision due in November, while NVL-330 is in early-stage clinical development for HER2-altered NSCLC.

名为neladalkib的ALK抑制剂也正在接受FDA对已接受过治疗的晚期ALK阳性非小细胞肺癌（NSCLC）的审查，预计将于11月作出决定；而NVL-330正处于针对HER2突变型非小细胞肺癌的早期临床开发阶段。

Analysts at Jefferies have previously suggested that the three drugs could generate sales of $5 billion to $7 billion a year at peak, which would be a massive boost to GSK as it chases down the target of building its annual revenues to £40 billion in 2031, from a little under £33 billion last year. They have suggested Jideytro's good tolerability profile could be a differentiator in the market..

杰富瑞分析师此前曾指出，这三种药物在销售峰值期每年可创造50亿至70亿美元的销售额，这将为葛兰素史克（GSK）提供强劲动力，助力其实现从去年的略低于330亿英镑增至2031年400亿英镑的年度营收目标。他们还表示，Jideytro良好的耐受性特征可能成为其在市场中的差异化优势。

Meanwhile, GSK is also developing another lung cancer candidate – B7-H3-targeted antibody-drug conjugate (ADC) risvutatug rezetecan (ris-rez) – which is licensed from Hansoh Pharma and recently had a positive phase 3 readout in relapsed small-cell lung cancer (SCLC).

与此同时，葛兰素史克（GSK）也在开发另一种肺癌候选药物——靶向B7-H3的抗体偶联药物（ADC）risvutatug rezetecan（ris-rez），该药授权自翰森制药，近期在复发性小细胞肺癌（SCLC）的III期临床试验中取得了积极结果。

Jideytro's approval has come nearly two months ahead of the FDA's action date for the application, and the company has said it intends to launch the product within the next few weeks. Pricing information has not yet been disclosed.

Jideytro 的获批时间比美国食品药品监督管理局（FDA）对该申请的行动日期提前了近两个月，该公司表示打算在未来几周内推出该产品。定价信息尚未公布。