Priority Review Continues with Successful Facility Inspections Completed,no Major Review Issues FDA Extends PDUFA Date to February 24, 2024 on Resource Constraints and Agrees to Work with Iovance to Expedite Remaining Review SAN CARLOS, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc.

优先审查继续完成成功的设施检查，没有重大审查问题FDA将PDUFA日期延长至2024年2月24日的资源限制，并同意与Iovance合作加速剩余审查加利福尼亚州圣卡洛斯，2023年9月14日（GLOBE NEWSWIRE）-Iovance Biotherapeutics，Inc。

(NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the U.S. Food and Drug Administration (FDA), because of resource constraints, requires additional time to complete the Priority Review of Iovance’s Biologics License Application (BLA) for lifileucel.

（纳斯达克股票代码：IOVA）是一家专注于为癌症患者创新，开发和提供新型多克隆肿瘤浸润淋巴细胞（TIL）疗法的生物技术公司，由于资源限制，今天宣布美国食品和药物管理局（FDA）需要额外的时间来完成针对lifileucel的Iovance生物制剂许可申请（BLA）的优先审查。

The BLA is seeking accelerated approval of lifileucel for patients with advanced melanoma. The FDA extended the new target action date for a decision under the Prescription Drug User Fee Act (PDUFA) to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date.

BLA正在寻求加速批准lifileucel用于晚期黑色素瘤患者。FDA根据处方药使用费法案（PDUFA）将新的目标行动日期延长至2024年2月24日，但同意与Iovance合作，加快剩余的审查，以便提前获得批准日期。

The FDA recently notified Iovance that they had insufficient resources to review a recent response to an information request for the ongoing BLA review prior to the planned late-cycle review meeting scheduled for September 11, 2023. In a meeting with the FDA held on September 14, 2023, the FDA acknowledged the resource constraints and agreed to work closely with Iovance to expedite the remaining review.

FDA最近通知Iovance，他们没有足够的资源来审查最近对计划于2023年9月11日召开的晚期周期审查会议之前正在进行的BLA审查的信息请求的回应。在2023年9月14日与FDA举行的会议中，FDA承认资源有限，并同意与Iovance密切合作，加快剩余的审查。

The overall BLA process continues under Priority Review with several recent positive status updates. The FDA reiterated there are no major review issues, and there are no plans to hold an advisory committee meeting. In addition, all pre-approval inspections of clinical sites. internal and external manufacturing and testing facilities have been successfully .

整个BLA过程继续进行优先审查，最近有几次积极的状态更新。FDA重申没有重大审查问题，也没有计划召开咨询委员会会议。此外，所有临床现场的审批前检查。内部和外部制造和测试设施已成功。