Camcevi是第一款准备注射的甲磺酸亮丙瑞林无菌制剂，用于皮下注射，采用预填充注射器，无需混合，治疗晚期前列腺癌！
2021年05月26日，美国逸達生物科技（Foresee Pharmaceuticals）宣布，美国食品药品监督管理局（FDA）已批准42毫克Camcevi（Leuprolide mesylate）甲磺酸亮丙瑞林6个月预充式皮下制剂,用于治疗晚期前列腺癌。
FDA的批准是基于一项137例晚期前列腺癌患者的3期研究，该研究证明每6个月使用Camcevi 42mg注射液治疗是有效，安全且耐受性良好的（ISI中列出了最常见的不良事件）。主要疗效终点是在受试（ITT）人群中，第28天以及从第28天到336天，血清睾丸激素被抑制（≤50ng/dl）的受试者的百分比。在97％的受试者中成功实现了主要功效终点，在第28天，平均睾丸激素浓度被抑制在cast割水平以下，降至17.6ng/dL。
对GnRH，GnRH激动剂类似物或Camcevi成分过敏的患者禁用Camcevi。
Camcevi 42mg（leuprolide mesylate）预充式亮丙瑞林缓释混悬注射剂 ，前称FP-001 LMIS 50mg。Camcevi 42 mg皮下注射剂是促性腺激素释放激素（Gonadotropin-releasing hormone, GnRH）激动剂。
关于Foresee Pharmaceuticals Co.Ltd
Foresee（逸達生物科技）是在台北证券交易所上市的台湾和美国生物制药公司。Foresee的研发工作集中在稳定化注射制剂（SIF）储库交付技术和针对特殊市场的衍生药物产品；其次针对具有高度未满足性的疾病领域的转型性临床前和临床的NCE计划需求。
Camcevi是基于Foresee专利的缓释针剂剂型技术（SIF，稳定注射剂）研发的新剂型新药产品。
关于Accord BioPharma
Accord BioPharma生物制药是总部位于印度的Intas Pharmaceuticals，Ltd.在美国的专业部门，Intas Pharmaceuticals，Ltd.是全球领先的跨国药物制剂开发，制造和营销公司之一。该公司以其在肿瘤，免疫学和重症监护三个重要治疗领域的产品系列而闻名。
Camcevi 42mg注射剂由Accord BioPharma独家负责在美国的商业化。
完整说明资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7a8761a-d953-413a-e053-2a95a90a60ee
信息来源：https://www.biospace.com/article/releases/foresee-pharmaceuticals-announces-fda-approval-of-camcevi-for-the-treatment-of-advanced-prostate-cancer-accord-biopharma-to-head-the-u-s-commercialization/
Camcevi（Leuprolide mesylate）
Generic Name & Formulations:
Leuprolide mesylate 42mg; per prefilled syringe; emulsion for SC inj.
Company:
Forsee Pharmaceutics Co., Ltd.
Prostate and other male cancers:
Indications for: CAMCEVI
Advanced prostate cancer.
Adult Dosage:
Give by SC inj on the upper- or mid-abdominal area. Avoid areas with brawny or fibrous tissue or locations that could be rubbed or compressed. 42mg once every 6months.
Children Dosage:
Not established.
CAMCEVI Contraindications:
Hypersensitivity to GnRH analogues.
CAMCEVI Warnings/Precautions:
May worsen metastatic vertebral lesions and/or urinary tract obstruction; monitor closely during first few weeks. Increased risk of diabetes, MI, sudden cardiac death, stroke. Monitor blood glucose, HbA1c, and for CVD signs/symptoms during therapy. Risk of QT prolongation in those with congenital long QT syndrome, CHF, or frequent electrolyte abnormalities. Correct and monitor electrolyte abnormalities; consider monitoring ECGs. Monitor serum testosterone levels post-inj. Embryo-fetal toxicity. Pregnancy. Nursing mothers: not recommended.
CAMCEVI Classification:
GnRH analogue.
CAMCEVI Interactions:
Caution with concomitant drugs known to prolong the QT interval.
Adverse Reactions:
Hot flush, hypertension, inj site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, pain in extremity; spinal cord compression, hyperglycemia, convulsions.
Generic Drug Availability:
NO
How Supplied:
Kit—1 (w. supplies)
https://www.camcevi.com/ |
