The FDA has approved MSD’s oral HIF-2 alpha inhibitor Welireg for a second cancer indication, relapsed or refractory advanced renal cell carcinoma (RCC), the most common form of kidney cancer.

FDA已批准MSD的口服HIF-2α抑制剂Welireg用于第二种癌症适应症，即复发或难治性晚期肾细胞癌（RCC），这是最常见的肾癌形式。

The green light comes two years after Welireg (belzutifan) became the first drug in the class to be approved for marketing, initially for von Hippel-Lindau (VHL) disease, an inherited condition that can cause tumours to develop in various organs of the body.

两年前，韦利雷（belzutifan）成为该类药物中第一种被批准上市的药物，最初用于治疗von Hippel-Lindau（VHL）疾病，这种遗传性疾病可导致身体各器官发生肿瘤。

MSD – known as Merck & Co in North America - acquired Welireg as part of its $2.2 billion takeover of Peloton Therapeutics in 2019, which included an upfront payment of $1.05 billion.

2019年，MSD以22亿美元收购了Peloton Therapeutics，其中包括10.5亿美元的预付款。MSD在北美被称为默克公司（Merck＆Co）。

The approval in RCC is for patients previously treated with PD-1/L1 and VEGF-targeted therapies, and according to Marjorie Green, head of late-stage oncology at Merck Research Laboratories (MRL) in the US, is “the first new therapeutic class available for eligible patients with advanced RCC in nearly a decade.”.

RCC的批准适用于先前接受PD-1/L1和VEGF靶向治疗的患者，据美国默克研究实验室（MRL）晚期肿瘤学负责人马乔里·格林（MarjorieGreen）称，这是“近十年来第一个新的治疗类别，适用于符合条件的晚期RCC患者。”。

RCC also unlocks a much larger patient population for the drug and is a key part of MSD’s blockbuster sales aspirations for Welireg along with a move into glioblastoma multiforme, a hard-to-treat form of brain cancer. Sales of the drug were $146 million in the first nine months of the year, up 75% on the same period of 2022..

RCC还为该药物打开了更大的患者群体，并且是MSD对Welireg的轰动销售愿望的关键部分，同时也是向多形性胶质母细胞瘤（一种难以治疗的脑癌）的转移。今年前9个月，该药物的销售额为1.46亿美元，比2022年同期增长了75%。。

The RCC approval comes after a priority review by the FDA and is based on the results of the phase 3 LITESPARK-005 trial, in which the drug showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, a go-to therapy for the disease..

RCC的批准是在FDA进行优先审查之后，并基于3期LITESPARK-005试验的结果，在该试验中，与依维莫司相比，该药物在无进展生存期（PFS）方面显示出统计学上显着且具有临床意义的改善，依维莫司是该疾病的一种常用治疗方法。。

After 18 months of follow-up, 22.5% of patients remained free of progression with Welireg, compared to 9% with everolimus, according to results presented at this year’s ESMO cancer congress in October. There was also a trend towards improved overall survival, with 55.2% and 50.6% of patients, respectively, still alive at that time point..

根据今年10月在ESMO癌症大会上公布的结果，经过18个月的随访，22.5%的患者仍然没有进展，而依维莫司为9%。总体生存率也有提高的趋势，当时分别有55.2%和50.6%的患者仍然活着。。

Renal cell carcinoma is by far the most common type of kidney cancer, accounting for about 9 out of 10 kidney cancer diagnoses, with approximately 15% of patients diagnosed at an advanced stage. The cancer is about twice as common in men than in women, and most cases are discovered incidentally during imaging tests for other abdominal diseases.

肾细胞癌是迄今为止最常见的肾癌类型，约占10例肾癌诊断中的9例，约15%的患者被诊断为晚期。这种癌症在男性中的发病率大约是女性的两倍，大多数病例是在其他腹部疾病的影像学检查中偶然发现的。

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LITESPARK-005 is one of four pivotal trials testing Welireg’s potential in RCC. The others are LITESPARK-011 and LITESPARK-012, evaluating Welireg in the second-line and treatment-naïve advanced disease settings, respectively, and LITESPARK-022 which is testing the drug in the adjuvant setting for locally advanced RCC..

LITESPARK-005是测试Welireg在RCC中潜力的四项关键试验之一。其他是LITESPARK-011和LITESPARK-012，分别在二线和未接受治疗的晚期疾病环境中评估Welireg，以及LITESPARK-022，该药物正在局部晚期RCC的辅助环境中测试。。