ImmunityBio Faces FDA Decision on Bladder-Cancer Application, Risk Remains
ImmunityBio’s push to expand Anktiva’s use in bladder cancer is back before the FDA, after the agency accepted a supplemental biologics license application. The FDA set a target action date for Jan. 6, 2027. ImmunityBio wants approval for Anktiva used with Bacillus Calmette-Guérin, or BCG, for BCG-unresponsive non-muscle invasive bladder cancer patients with papillary disease and no carcinoma in situ.