ImmunityBio's (IBRX) supplemental biologics license application for Anktiva in combination with Bacillus Calmette-Guerin in patients with bladder cancer with papillary disease has been accepted for review by the US Food and Drug Administration, the company said late Tuesday.

The filing was supported by results from a phase 2/3 trial, which met its primary endpoint with a 12-month disease-free survival rate of 58.2%, ImmunityBio said.

The regulator has set a Prescription Drug User Fee Act target action date of Jan. 6, 2027, the company said.