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美国食品和药物管理局(FDA)已授予PharmaMar的Lurbinectedin孤儿药物认定

2018-08-05 MedSci MedSci原创

PharmaMar近日宣布,lurbinectedin已获FDA的孤儿药物认定,用于治疗小细胞肺癌,以支持药品的开发,以便安全有效地治疗、诊断或预防影响美国不到20万人的罕见疾病。

PharmaMar近日宣布,lurbinectedin已获FDA的孤儿药物认定,用于治疗小细胞肺癌,以支持药品的开发,以便安全有效地治疗、诊断预防影响美国不到20万人的罕见疾病。孤儿药物名称可能提供的益处包括药物批准时的7年市场独占期、合格临床试验的税收抵免以及免除FDA申请费等。

小细胞肺癌肺癌的基本类型之一,属于未分化癌,小细胞肺癌由肺Kulchitsky细胞恶变而来,其病理类型包括燕麦细胞型、中间细胞型和复合燕麦细胞型。20~25%的肺癌患者属于这种类型,是一种恶性程度较高的肺癌。该病男性多发于女性,发病部位以大支气管(中心型)居多。临床特点为肿瘤细胞倍增时间短,进展快,常伴内分泌异常或类癌综合征。

PharmaMar的总经理Luis Mora说:我们很高兴获得这种孤儿药的称号,因为它强调了对这种癌症的创新性,以及对有效治疗的巨大需求,并认识到lurbinectedin可能为小细胞肺癌患者提供的潜在益处


原始出处:

http://www.firstwordpharma.com/node/1582986?tsid=4#axzz5NCMJrdAy

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    2019-03-17 aliceclz
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    2019-04-04 jj000001
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