Investing News NetworkSeptember 19, 2024Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to Amplia’s Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer.

投资新闻网2024Amplia Therapeutics Limited（ASX:ATX）（“Amplia”或“公司”）很高兴地宣布，美国食品和药物管理局（FDA）已授予Amplia粘着斑激酶抑制剂narmafotinib快速通道指定，用于治疗晚期胰腺癌。

HIGHLIGHTSThe US FDA has granted Fast Track Designation to Amplia’s lead drug narmafotinib in advanced pancreatic cancerFast Track Designation facilitates the development of investigational drugs and allows for expedited review Fast Track Designation is available to drugs that may provide an advantage over current therapies in the treatment of serious conditions.

亮点美国食品和药物管理局（FDA）已授予Amplia的领先药物纳马非替尼在晚期胰腺癌中的快速通道指定。快速通道指定有助于研究药物的开发，并允许快速审查快速通道指定可用于治疗严重疾病的药物，这些药物可能比目前的治疗方法具有优势。

It is designed to speed the development of these drugs to enable patients to receive them sooner. This Designation will grant the Company access to more frequent meetings, and written communication, with the FDA. In future, narmafotinib may be eligible for Accelerated Approval and Priority Review. The Company has previously received Orphan Drug Designation from the FDA for narmafotinib in pancreatic cancer.The Company’s CEO and Managing Director, Dr Chris Burns, commented, “Fast Track Designation for narmafotinib is a significant milestone for the Company.

它旨在加速这些药物的开发，使患者能够更快地接受它们。这一任命将允许该公司与FDA进行更频繁的会议和书面沟通。将来，纳马非替尼可能有资格获得加速批准和优先审查。该公司此前已获得FDA指定的用于治疗胰腺癌的那马非替尼的孤儿药。该公司首席执行官兼董事总经理克里斯·伯恩斯博士评论道：“快速指定纳马非替尼是该公司的一个重要里程碑。

With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease.”Amplia’s clinical trial in advanced pancreatic cancer, the ACCENT trial, is ongoing in Australia and South Korea.

有了这个称号，我们可以与FDA更密切地合作，加速我们的临床计划，并收集最有说服力的证据，以获得这种毁灭性疾病的监管批准。”Amplia在晚期胰腺癌中的临床试验，即ACCENT试验，正在澳大利亚和韩国进行。

Earlier this year, the Company announced that the US FDA had cleared its IND1 application for a trial of narmafotinib in pancreatic cancer in the US. This trial is in advanced planning stages.This ASX announcement was approved and auth.

今年早些时候，该公司宣布，美国FDA已批准其IND1申请，在美国进行纳马非替尼治疗胰腺癌的试验。该试验处于晚期计划阶段。本ASX公告已获批准并授权。