AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC

阿斯利康Imfinzi一线治疗广泛期小细胞肺癌(SCLC)获美国FDA优先审查!

2019-12-02 09:40:05 PHARMACEUTICAL

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Imfinzi holds approvals for the curative-intent setting of unresectable, stage III non-small cell lung cancer following chemoradiation therapy across 54 countries, including the US, the European Union, and Japan. The approvals in the type of lung cancer were granted based on the results of the phase 3 PACIFIC trial. The AstraZeneca drug is also approved for the treatment of advanced bladder cancer in previously treated patients, and for locally-advanced or metastatic urothelial carcinoma in various countries. For its approval in extensive SCLC in treatment-naïve patients, AstraZeneca had submitted the drug’s supplemental Biologics License Application (sBLA) based on the results from the phase 3 CASPIAN trial. SCLC is considered to be an aggressive, fast-growing form of lung cancer. The condition is known to recur and progress rapidly in spite of initial response to platinum-based chemotherapy. In the CASPIAN trial, Imfinzi in combination with standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to SoC alone. The risk of death with the investigational treatment was brought down by 27% with median OS of 13.0 months compared to 10.3 months recorded for SoC. According to AstraZeneca, results from the phase 3 trial showed an estimated 33.9% of patients survived at 18 months after receiving the investigational treatment compared to 24.7% of patients who were on SoC treatment. Imfinzi’s Prescription Drug User Fee Act date for the SCLC indication has been set for the first quarter of 2020 by the FDA. The oncology immunotherapy was previously granted orphan drug designation (ODD) for the same indication by the FDA in July 2019. Imfinzi is a human monoclonal antibody designed to target the PD-1/PD-L1 pathway. The oncology immunotherapy prevents the interaction of PD-L1 with PD-1 and CD80 proteins and through this mechanism, works against the immune-evading tactics of the tumour to release the inhibition of immune responses.
Imfinzi 持有在包括美国、欧盟和日本在内的54个国家进行化学放射治疗后的不可切除 III 期非小细胞肺癌的治疗意图设定的批准。根据三期 PACIFIC 试验的结果,批准了肺癌的类型。 阿斯利康(AstraZeneca)的药物也被批准用于治疗以前治疗的患者的晚期膀胱癌,以及在不同国家的局部晚期或转移性尿路上皮癌。 阿斯利康(AstraZeneca)已根据 CASPIAN 第三阶段试验的结果提交了该药物的补充生物逻辑许可证申请( sBLA ),以获得治疗偏头痛患者广泛 SCLC 的批准。 SCLC 被认为是一种侵袭性的、快速生长的肺癌。尽管对铂类化疗有初步反应,但已知这种情况会复发并迅速发展。 在 CASPIAN 试验中, Imfinzi 联合标准护理( SoC )化疗(依托泊苷联合顺铂或卡铂)显示与单纯 SoC 相比,整体生存( OS )有统计学意义和有临床意义的改善。 研究治疗的死亡风险降低了27%,中位 OS 为13.0个月,而 SoC 为10.3个月。 根据阿斯利康(AstraZeneca)的数据,第三阶段试验的结果显示,在接受调查治疗后18个月内,大约有33.9%的患者存活下来,而接受 SoC 治疗的患者为24.7%。 Imfinzi 的处方药用户费用法案日期为 SCLC 适应症已被 FDA 设定为2020年第一季度。肿瘤免疫治疗于2019年7月被 FDA 授予孤儿药物指定( ODD )相同适应症。 Imfinzi 是一种针对 PD-1/ PD-L1通路设计的人源单克隆抗体。肿瘤免疫治疗防止 PD-L1与 PD-1和 CD80蛋白相互作用,通过这种机制,对抗肿瘤的免疫回避策略,从而释放免疫反应的抑制。

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