Chimeric Therapeutics (ASX:CHM) said that the US Food and Drug Administration (FDA) granted fast-track designation to its CHM CDH17 chimeric antigen receptor T-cell (CAR-T) therapy for treating advanced gastroenteropancreatic neuroendocrine tumors in patients who have progressed after prior treatment, according to a Wednesday filing with the Australian bourse.
Fast-track designation aims to expedite the development and review of treatments for serious conditions with unmet needs, providing increased interaction with the US FDA and potential eligibility for a priority review and a rolling biologics license application review, the filing said.
CHM CDH17 is currently in a trial phase assessing safety and efficacy in advanced colorectal, gastric, and intestinal neuroendocrine cancers, the filing added.
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