PD-1拦截判决同意的晚期黑色素瘤

StephenW

PD-1 Blocker OK'd for Advanced Melanoma

Published: Sep 4, 2014

By John Gever, Managing Editor, MedPage Today



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Pembrolizumab (Keytruda) has won FDA approval for treating advanced or unresectable melanoma in patients not responding to other therapies, the agency said Thursday.
The monoclonal antibody drug inhibits the PD-1 pathway, which prevents immune-mediated killing of melanoma cells. Pembrolizumab thus makes it possible for anti-tumor T cells to attack melanoma tumors. It's the first approved product with this mechanism of action.
Some oncologists have already called this approach "a major breakthrough" for metastatic melanoma.
"Keytruda is intended for use following treatment with ipilimumab," sold as Yervoy, the FDA noted in announcing the approval. In patients with the V600 BRAF mutation, patients should also have received a BRAF inhibitor before starting pembrolizumab.
The agency explained that this was an accelerated approval and that "improvement in survival or disease-related symptoms has not been established" for the drug. Under such approvals, the drug's sponsor  --  Merck & Co., in this case  --  must perform additional studies to confirm a clinical benefit. The FDA announcement did not indicate what specifically it would require from Merck.
Pembrolizumab's efficacy was demonstrated in uncontrolled studies involving 173 patients; the studies had reductions in tumor volume as the primary outcomes. In those receiving the recommended dose of 2 mg/kg, 24% showed tumor shrinkage, the FDA said. A 10-mg/kg dose had a similar level of efficacy.
"The effect lasted at least 1.4 to 8.5 months and continued beyond this period in most patients," the agency said.
Experience with the drug in 411 patients provided the safety data. Fatigue, cough, nausea, pruritus, rash, anorexia, constipation, arthralgia, and diarrhea were the most common side effects, according to the FDA. Less frequently, severe immune-mediated adverse effects involving the lungs, colon, liver, and endocrine glands were seen.

PD-1拦截判决同意的晚期黑色素瘤

发布时间：2014年9月4日
由约翰·Gever，总编辑，MedPage今天
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Pembrolizumab（Keytruda）赢得了FDA批准用于患者不回应其他疗法治疗晚期或无法手术切除的黑色素瘤，该机构周四表示。

单克隆抗体药物抑制PD-1的通路，这可以防止免疫介导的杀伤黑素瘤细胞。 Pembrolizumab从而使得有可能用于抗肿瘤T细胞攻击黑色素瘤。这是首个获批的产品，这种作用机理。

有些肿瘤专家已经呼吁该办法“的一大突破”为转移性黑色素瘤。

“Keytruda旨在用于以下治疗易普利姆玛”为Yervoy出售，美国食品药品管理局在宣布批准注意到。在患者V600 BRAF突变的患者，应也开始pembrolizumab之前收到的BRAF抑制剂。

该机构解释说，这是一个加速的批准，以及“改善生存或疾病相关症状尚未建立”为药。在这样的批准，该药的赞助商 - 默克公司，在这种情况下 - 必须进行更多的研究来确认临床益处。 FDA的公告没有指明具体是什么它需要从默克公司。

Pembrolizumab的功效表现在，涉及173例非对照研究;该研究有减少肿瘤体积的主要成果。在那些接受2毫克/千克的推荐剂量，24％表现为肿瘤缩小，FDA表示。有10毫克/千克剂量组疗效相近的水平。

“的效果持续了至少1.4至8.5个月，并不断超越这一时期的大多数患者，”该机构说。

在411例患者的用药经验所提供的安全数据。疲劳，咳嗽，恶心，皮肤瘙痒，皮疹，食欲不振，便秘，关节痛，腹泻是最常见的副作用，根据FDA。较不频繁，累及肺，结肠，肝，和内分泌腺体严重的免疫介导的不良影响进行了观察。

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StephenW

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