Research & Development
enGene granted FDA's FTD for EG-70 for non-muscle invasive bladder cancer
4 December 2020 -

Biotechnology company enGene Inc reported on Thursday the receipt of the US Food and Drug Administration's (FDA) Fast Track Designation for EG-70 for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer.

According to the company, EG-70 is its lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).

The company said the therapeutic programmes that receive Fast Track Designation can benefit from more frequent communication with the FDA, eligibility for Priority Review and Accelerated Approval, and potentially for Rolling Review of the marketing application.

Following the US FDA's recognition of the company's EG-70 programme, it now looks forward to working closely with the USFDA throughout the clinical development process to bring this innovative treatment to patients as quickly as possible, added CEO Jason Hanson.

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