First completed CAR-T therapy for aggressive NHL filed with FDA

A completed rolling submission has been filed with the US Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel (previously known as KTE-C19) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT).

“Last month, we announced positive results from our ZUMA-1 pivotal trial with axicabtagene ciloleucel,” said Arie Belldegrun, chairman, president and chief executive of Kite Pharma (Nasdaq: KITE), the drug’s developer, adding: “We look forward to working closely with the FDA during the review of axicabtagene ciloleucel and the possibility of bringing this therapy to patients with aggressive NHL whose outlook is dismal with current therapy.”

In its press release, Kite describes this as the first CAR-T therapy submission completed for patients with aggressive NHL. The question now is whether the FDA will treat the drug as a priority review, which means the agency could decide four months earlier than a standard review. Kite’s shares edged up 2.6% to $78.49 in after-hours trading on Friday.