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脑转移性乳腺癌的治疗进展:FDA授予NERLYNX孤儿药物指定

2019-09-04 Allan MedSci原创

Puma生物制药公司近日宣布,美国FDA已授予NERLYNX®(neratinib)孤儿药物指定,用于治疗乳腺癌脑转移患者。

Puma生物制药公司近日宣布,美国FDA已授予NERLYNX®neratinib)孤儿药物指定,用于治疗乳腺癌脑转移患者。Puma生物制药首席执行官兼总裁Alan H. Auerbach说:“NERLYNX的孤儿药指定标志着我们继续为HER2阳性乳腺癌患者开发治疗方法的进展和承诺。尽管针对HER2阳性乳腺癌的治疗选择有所扩大,但脑转移代表了一个重要的临床挑战。NERLYNX的肿瘤穿透性代表了一种潜在的治疗选择

FDA的孤儿药物指定旨在服务美国罕见疾病(少于200,000人)患者。这些药物在获准上市后可获得七年市场独占权,免除FDA申请费,临床试验的税收抵免和药物开发过程中的其他潜在援助。


原始出处:

http://www.firstwordpharma.com/node/1663665#axzz5yVqufGke

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