First CAR-T therapy BLA filing initiated with US FDA
A rolling submission with the US Food and Drug Administration of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT) has been initiated by Kite Pharma (Nasdaq: KITE).
The pivotal ZUMA-1 study supporting this submission – said to be the first CAR-T therapy BLA filing in the USA - enrolled patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL), three subtypes of aggressive NHL.
The company expects to complete its BLA submission by the end of the first quarter of 2017. The US Adopted Name, or USAN, for KTE-C19 will be axicabtagene ciloleucel.
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