FDA accepts ImmunityBio sBLA for ANKTIVA plus BCG in papillary NMIBC

ImmunityBio Inc

ImmunityBio Inc

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  • ImmunityBio secured FDA acceptance for review of a supplemental BLA seeking to expand ANKTIVA with BCG into BCG-unresponsive non-muscle invasive bladder cancer with papillary-only disease.
  • 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 12-month disease-free survival of 58.2%.


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