Imugene (ASX:IMU) said the US Food and Drug Administration (FDA) confirmed data from the current phase 1b study with azer-cel therapy candidate plus IL-2 dosing regimen, including lymphodepletion conditioning, along with the safety profile, supported advancing to phase three registrational study, according to a Monday Australian bourse filing.

It received written minutes from the FDA following its recent Type C meeting. This included directional confirmation that its proposed regimen for the pivotal program, which includes augmented lymphodepletion followed by a flat 500 million cell dose of azer-cel with 14 days of subcutaneous low-dose IL-2, is appropriate.

The regulator endorsed the firm's dual-end point strategy, with overall response rate and durability being used for accelerated approval, and progression-free survival being used for full approval. It also asked that the control arm include several investigator-choice therapies.

The third line and later diffuse large B-cell lymphoma, including patients who relapsed after autologous CAR-T cell therapy, was accepted as the registrational study population.

The firm's shares jumped 6% in recent trading on Monday.