FDA accepts priority review for Kite Pharma’s refractory aggressive NHL treatment


The US Food and Drug Administration (FDA) has accepted priority review for cell therapy company Kite Pharma’s biologics licence application (BLA) for axicabtagene ciloleucel to treat patients with refractory aggressive non-Hodgkin lymphoma (NHL).

Axicabtagene ciloleucel is an investigational therapy whereby a patient's T-cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19 and redirect the T-cells to destroy cancer cells.

CD19 is a protein expressed on the cell surface of B-cell lymphomas and leukaemia.

The company submitted the BLA following positive data demonstrated with a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase II trial in patients with refractory aggressive NHL.

Kite Pharma research and development executive vice-president Dr David Chang said: “Patients with refractory aggressive NHL face a dire prognosis, with only a 50% chance of surviving six months.

"Patients with refractory aggressive NHL face a dire prognosis, with only a 50% chance of surviving six months."

“This underscores the urgent medical need for these patients and why every day matters, from development to manufacturing to clinical experience.

“We firmly believe in the potential for axicabtagene ciloleucel to address this need and forge a new path for the future of cell therapy.”

The BLA acceptance is supported by data obtained from the ZUMA-1 Phase II trial, which met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel with 82%.

At a median follow-up of 8.7 months, 44% of patients were in ongoing response, including 39% of patients in complete response (CR).

In the third quarter of this year, Kite Pharma expects to submit the market authorisation application (MAA) of axicabtagene ciloleucel with the European Medicines Agency (EMA).