ImmunityBio says FDA accepts ANKTIVA sBLA for papillary NMIBC; PDUFA Jan. 6, 2027

ImmunityBio Inc

ImmunityBio Inc

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  • ImmunityBio’s supplemental BLA seeking to expand ANKTIVA with BCG into BCG-unresponsive non-muscle invasive bladder cancer with papillary-only disease was accepted for FDA review.
  • The FDA set a PDUFA target action date of Jan. 6, 2027.
  • The filing is supported by QUILT-3.032 Cohort B data in 80 patients, including a 12-month disease-free survival rate of 58.2%.


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