FDA approves 2nd CAR-T cell therapy, this one for certain type of lymphoma

The US Food and Drug Administration yesterday approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.

Yescarta, developed by Kite Pharma, which is now a subsidiary of US biotech giant Gilead Sciences (Nasdaq: GILD) following its $11.9 billion acquisition this year, is a chimeric antigen receptor (CAR) T cell therapy. It is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

The approval was widely expected, but Gilead’s shares nevertheless edged up 2.8% to $80.01 (having hit $81.60 at one point) in after-hours trading yesterday.