The US Food and Drug Administration (FDA) has approved US-based Kite Pharma's chimeric antigen receptor T cell therapy, Yescarta (axicabtagene ciloleucel), intended for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy, it was reported on Friday.

The product's approval includes patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL resulting from follicular lymphoma (transformed follicular lymphoma, or TFL). However, the Kite Car T therapy has not been indicated by the FDA for the treatment of primary central nervous system lymphoma.

Kite's CAR T therapy will be customised as per the individual patient's requirement and is available at a price of USD373,000 in the US.

According to the FDA, Yescarta is the second gene therapy it has approved and the first for certain types of non-Hodgkin lymphoma (NHL).