英文药名：KEYTRUDA Injection（Pembrolizumab(Genetical Recombination)）

中文药名：派姆单抗重组注射剂

生产厂家：MSD有限公司

キイトルーダ点滴静注20mg／キイトルーダ点滴静注100mg

治疗类别名称
- 抗肿瘤药 -
人源化抗人PD-1单克隆抗体
批准日期：2017年2月
商標名
KEYTRUDA Injection 20mg
KEYTRUDA Injection 100mg
一般名
ペムブロリズマブ(遺伝子組換え)
Pembrolizumab(Genetical Recombination)
分子量
約149,000
本質
重组人源化单克隆抗体，小鼠抗人PD-1抗体的互补性决定部分，并且由一框架部分与人IgG4的恒定部分，H链228的氨基酸残基被取代成Pro的那里。它与由L个链中的两个447个H链的两个包含氨基酸残基和由中国仓鼠卵巢细胞中产生的218个氨基酸组成的糖蛋白。
条件批准
1.建立药品风险管理计划的顶部，要正确实施。
2.由于试验病人在日本是非常有限的，上市后，直至有关一定数量的病例数据集成，通过实现对一切案件的使用，结果调查显示，这使得它能够及早发现这种药物的使用患者的背景资料，数据收集这种药物的安全性和有效性，采取必要的措施，正确使用此药。
药效药理
作用机序
本剂是抗人PD-1的抗体，通过抑制PD-1与其配体（PD-L1和PD-L2），肿瘤特异性细胞毒性T细胞被激活的结合，它被认为是抑制肿瘤生长。
适应症
*不能切除的根治恶性黑色素瘤
*PD-L1的非小细胞肺癌的不可切除晚期或复发
用法与用量
*不能切除的根治恶性黑色素瘤
成人，经30分钟，在3周的时间间隔，为2mg/kg体重的一个周期的静脉输液。
*不能切除晚期或复发的非小细胞肺癌PD-L1阳性
成人，在30分钟期间内静脉滴注一次200毫克在三个周的间隔。
包装规格
静脉滴注
20毫克/0.8ml：1瓶
100毫克/4mL： 1瓶

制造厂商
MSD有限公司
提携
大鹏药业有限公司
KEYTRUDA Injection 20mg/100mg(Kiituruda drip infusion 20 mg/100mg)
Release of anti-PD-1 antibody/anti-neoplastic agent "Quitruda®"
MSD) today announced the introduction of a "humanized anti-human PD-1 monoclonal antibody (anti-PD-1 antibody)" Kiroda ® IV infusion 20 mg ", a product of Hitachi, Ltd. (Headquarters: Chiyoda-ku, Tokyo; president: Yanny West Heisen (Generic name: pemblrolizumab (genetical recombination)), "Kiitruda®IV infusion IV" 100mg.
Kyotoruda ® has been approved for the indications and effects of malignant melanoma that can not be cured and PD-L1 positive unresectable progression/relapse non-small cell lung cancer.
In lung cancer, Kuitruda ® is an international joint Phase III clinical trial (KEYNOTE-024 study) for patients with unprotected progression-free relapsing non - treated non - small cell lung cancer positive for PD-L1 and previously treated non - small - cell lung cancer Effectiveness and safety were demonstrated in the international joint 2/3 clinical trial (KEYNOTE - 010 examination) for patients. Kyotoruda® can be used for initial treatment (PD-L1 highly expressed cases) and previously treated (PD-L1 expressing cases) for patients with nonresectable non-small cell lung cancer with unresectable PD-L1 positive/1 antibody.
In Malignant Melanoma, Kyotoruda®is an oversea Phase 2 study (KEYNOTE-002 test) for overseas malignant melanoma patients, a Phase 3 overseas study (KEYNOTE - 006 study) and a Phase I Phase 1 study (KEYNOTE-041 test), efficacy and safety were shown.
Kitoidruda® is an anti-PD-1 antibody that inhibits the interaction between PD-1, a receptor that is mainly expressed in T cells, and ligands*1 PD-L1 and PD-L2 that are expressed on tumor cells. By combining with PD-1(receptor) and inhibiting the binding of this receptor to the ligand, Kyotoruda ® releases the inhibition of the anti-tumor immune response through the PD-1 pathway of tumor cells.
PD-L1 IHC 22C3 pharmDx ™ "Dako" of Agilent Technologies Co., Ltd. got approval in Japan on November 25, 2016 in order to examine the expression status of PD-L1 of tumor cells as a companion diagnostic agent of Kyotoroda® doing. This diagnostic agent expresses PD-L1 in untreated patients with high expression of PD-L1(TPS*2≧50%) in non-small cell lung cancer expected to have a therapeutic effect by Kytroda ®, and also in PD-L1 in non small cell lung cancer It is aimed to identify patients who have history of treatment (TPS≥1%).
On October 27, 2015, Kyotoruda ® is designated as one of the first items to be considered for the first time after the "pioneering examination designation system" from the Ministry of Health, Labor and Welfare regarding the indications and effects on progressive/recurrent gastric cancer which is curative unresectable I will. Also, late stage targeting bladder cancer, breast cancer, stomach cancer, head and neck cancer, liver cancer, multiple myeloma, esophageal cancer, renal cell carcinoma, colon cancer, ovarian cancer, prostate cancer Clinical trials are ongoing. On December 22, 2016, we apply for partial change approval for manufacturing and marketing approval matters concerning the efficacy and efficacy against recurrent or refractory classical Hodgkin's lymphoma.
Kiitroda ® has been approved in more than 50 countries including the United States, and around 400 clinical trials are ongoing for more than 30 cancers worldwide.
■ Kiyuruda ® drug provision before drug price listing
MSD is a non-small cell lung cancer with PD-L1-positive unresectable progression-relapse with limited treatment, without chemotherapy history, EGFR gene mutation negative, ALK fusion gene negative and PD-L1 positive TPS≧50%) as soon as possible to respond to the urgent demand of the patient, we have been offering Kiito Rada ® free of charge only for the period up to the receipt of drug price criteria. This free offer will be terminated as the sale starts today.
MSD will manufacture and sell Kirodooda®, and promotion will be carried out in collaboration with Taiho Pharmaceutical Co., Ltd.
MSD positions the oncology field as one of its priority areas. We will strive to contribute to patients and health care workers even more through the release of Kiitoda®.
1 Ligand specifically binds to a specific receptor (receptor)
2 TPS: Tumor Proportion Score percentage of PD-L1 expression positive cells among tumor cells
Reference material
Anti-malignant tumor agent "Quitruda®"
Product name KIYO RUDA®IV infusion 20mg
KIYO RUDA®IV infusion IV
Generic name pemblrolizumab (genetical recombination)
Indication
Radical cure of malignant melanoma
PD-L1 positive unresectable progression-relapsing non-small cell lung cancer
Dosage regimen
<Malignant melanoma with radical cure>
Usually in adults, as pemblrolizumab (genetical recombination)
Intravenous drip infusion over 2 weeks at 3 mg/kg body weight once a day for 30 minutes.
<Non-small cell lung carcinoma with PD-L1 positive unresectable progression and relapse>
Usually in adults, as pemblrolizumab (genetical recombination)
Intravenous infusion of 200 mg once every 3 week intervals over 30 minutes.
Approval Date of acquisition Malignant melanoma unresectable: September 28, 2016
PD-L1 positive unresectable progression-relapsing non-small cell lung cancer:
December 19, 2016
Drug price criteria reporting date
Release date February 15, 2017
http://www.info.pmda.go.jp/go/pack/4291435A1029_1_01/