Off-the-shelf CAR T hits fast track

Imugene has had its shift from a clinical stage company to a commercial one sped up with a new designation from the FDA.

The FDA has granted Imugene's allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel), fast track designation for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the company announced today.

"Receiving FDA Fast Track Designation is a testament to the transformative potential of azer-cel for patients battling relapsed or refractory DLBCL," Imugene CEO, Leslie Chong, said. "We are committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible."