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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval