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Gilead's Kite Pharma Earns FDA Nod For Yescarta For Type Of Blood Cancer

  • The FDA has granted accelerated approval to Gilead Sciences Inc's (NASDAQ: GILDKite Pharma's 'Yescarta' (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • This approval makes 'Yescarta' the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma.
  • The treatment follows FDA Breakthrough Therapy Designation, priority review, and marks the third approved indication for a Kite cell therapy.
  • The approval is based on results from the ZUMA-5 open-label study in which 91% of patients with relapsed or refractory FL (n=81) responded to Yescarta, including an estimated 74% of patients in a continued remission at 18 months.
  • Price Action: GILD shares are down 0.96% at $64 in the premarket session on the last check Monday.

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Posted-In: Follicular LymphomaBiotech News Health Care FDA General

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