ImmunityBio (IBRX) said Monday it has asked for a prompt meeting with the US Food and Drug Administration after the agency declined to review its supplemental application for ANKTIVA in combination with Bacillus Calmette-Guerin, or BCG, to treat bladder cancer that is unresponsive to BCG and has not spread to surrounding tissue.
The company said the FDA's refusal contradicted earlier direction given during a January meeting where senior officials reportedly supported the filing of the application based on a single trial's results from QUILT 3.032.
The previously approved use of ANKTIVA in patients with both papillary tumors and CIS had been based on the same clinical study, the company said, highlighting what it sees as a conflicting regulatory stance.
ImmunityBio cited long-term results in the papillary-only group, including over 96% survival specific to the disease at three years and more than 82% of patients avoiding bladder removal.
Shares of the company were down more than 8% in recent Monday premarket activity.
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