FDA grants orphan drug designation to T-cell therapies for advanced liver cancer

fda grants orphan drug designation to t cell therapies for advanced liver cancer

Sumary of FDA grants orphan drug designation to T-cell therapies for advanced liver cancer:

  • The FDA granted orphan drug designation to two investigational T-cell immunotherapies for the treatment of advanced hepatocellular carcinoma.
  • ET140203 is engineered to express a T-cell receptor (TCR) that targets an alpha fetoprotein-peptide/HLA-A2 complex.
  • “These designations for Eureka’s clinical candidates underscore the significant unmet medical need for more effective liver cancer treatment options,” Cheng Liu, PhD, president and CEO of Eureka Therapeutics, said in a company-issued press release.
  • The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.
  • The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

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