Eli Lilly and Company 今天宣布，美国食品药品监督管理局 (FDA) 已就研究药物 sintilimab 注射液的生物制品许可申请 (BLA) 发出了完整的回复信 (CRL)，这是一种 PD-1 抑制剂与培美曲塞和铂类化疗用于非鳞状非小细胞肺癌 (NSCLC) 患者的一线治疗。 Sintilimab 由 Innovent Biologics , Inc .和礼来公司开发。
这封信表明审查周期已完成，但 FDA 无法批准目前形式的申请，这与 XNUMX 月份肿瘤药物咨询委员会会议的结果一致。 CRL 包括一项额外临床研究的建议，特别是一项多区域临床试验，将一线转移性 NSCLC 的护理治疗标准与信替利单抗与采用非劣效性设计和总生存期终点的化疗进行比较。
礼来与 Innovent 正在评估美国 sintilimab 项目的下一步计划
从这篇文章中可以得到什么：
- Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine sintilimab injection, a PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC).
- The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint.
- The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February.
