Gilead : FDA Okays New Label Update For CAR T-Cell Therapy Yescarta

(RTTNews) - Kite, a Gilead Co. (GILD), said Monday that the U.S. Food and Drug Administration has approved an update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications.

Yescarta is now the first and only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects, the company said in a statement.

Patients can currently access Kite's CAR T-cell therapies through 111 authorized treatment centers across the U.S. that are experienced in administering and managing patients being treated with CAR T-cell therapy.

Yescarta was the first CAR T-cell therapy to be approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

Yescarta is also currently under review in the U.S. and European Union for use as an earlier treatment of adult patients with second-line relapsed or refractory LBCL.