PharmaMar and Jazz Pharmaceuticals plc announce that a New Drug Application for Lurbinectedin has been accepted by FDA and granted Priority Review for Relapsed Small Cell Lung Cancer.
The Priority Review by the FDA is for patients with Small Cell Lung Cancer (SCLC) who have progressed after prior platinum-containing therapy.
A Prescription Drug User Fee Act or PDUFA date is set for August 16, 2020.
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PharmaMar 和 Jazz Pharmaceuticals plc 宣布， Lurbnextein 的新药申请已被 FDA 接受，并获得复发小细胞肺癌的优先审查。
FDA 的优先审查是针对小细胞肺癌（ SCLC ）患者，他们在接受含铂治疗后取得进展。
处方药用户费法或 PDUFA 日期设定为2020年8月16日。
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