Investigational CAR-T therapy meets endpoint objectives on the first dose.

Following positive data demonstrated from single infusions of axicabtagene ciloleucel in its ZUMA-1 Phase II patient trial, Kite Pharma announced on May 26^th, that the FDA has accepted the Biologics License Application (BLA) for axicabtagene ciloleucel, its innovative personalized cell therapy for Non-Hodgkin Lymphoma (NHL) for priority review.

According to Kite Pharma, data from its ZUMA-1 Phase II trial met the primary endpoint objective response rate (ORR) recorded after a single infused dose—a critical element of the FDA’s decision to grant the therapeutic agent priority review.

Underscoring the urgent need of patients for an effective therapy, Kite’s EVP of R&D and Chief Medical Officer David Chang explained, “Patients with refractory aggressive NHL face a dire prognosis with only a 50 percent 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,” said Chang. He also noted that the company firmly believes that axicabtagene ciloleucel has the potential to chart “a new path for the future of cell therapy.”

The company has said that axicabtagene ciloleucel, which received Breakthrough Therapy Designation from the FDA in 2015, is one of the lead product candidates. An investigational therapy, axicabtagene ciloleucel takes a patient’s T-cells and engineers them to target the antigen CD19 a protein on the surface of B-cell lymphomas and leukemia’s. The therapy redirects the T-cells to kill cancer cells.