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: GILD) Kite 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.