Gilead's Yescarta gets approval in EU for expanded use in blood cancer subtype
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The European Commission (EC) approved the expanded use of Gilead's (NASDAQ:GILD) CAR T-cell therapy Yescarta to treat adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
The company said Yescarta has maintained orphan medicinal product designation in this indication.
Yescarta, developed by Gilead's unit Kite, is already approved to treat adult patients with relapsed or refractory diffuse large Bâcell lymphoma and primary mediastinal large Bâcell lymphoma, after two or more lines of systemic therapy.
FL is a cancer which affects a type of white blood cell called lymphocyte. It is a type of non-Hodgkin lymphoma in which tumors grow slowly but can become aggressive over time.
The EC approval follows a positive opinion for Yescarta by a panel of the European Medicines Agency in April.