Gilead Sciences Says Yescarta Won FDA Label Update, Removing Use Limits for Relapsed CNS Lymphoma Patients

MT Newswires Live
Feb 06

Gilead Sciences' (GILD) Kite said Friday that the U.S. Food and Drug Administration approved an update to the prescribing label for Yescarta, removing a prior limitation on use in patients with relapsed or refractory primary central nervous system lymphoma.

The change makes Yescarta the only CAR T-cell therapy for large B-cell lymphoma without this restriction, the company said. Primary CNS lymphoma is rare and aggressive, with a five-year survival rate of about 30%, and limited treatment options after relapse.

The FDA decision was based on a Phase 1 study led by Dana-Farber Cancer Institute, according to the company. In the study, most patients experienced neurologic side effects, but the safety profile supported use in this population, it said.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10