ImmunityBio Resubmits Supplemental Biologics License Application for Cancer Treatment Anktiva

MT Newswires Live03-09

ImmunityBio (IBRX) said Monday it has resubmitted its supplemental biologics license application for its non-muscle invasive bladder cancer treatment Anktiva to the US Food and Drug Administration, after including updated efficacy date as requested by the agency.

The company said it resubmitted the application for patients with papillary-only non-muscle invasive bladder cancer treatment, including updated long-term follow-up data, with the agency acknowledging receipt of the filing.

The application is supported by long-term results from a phase 2/3 trial that show the potential of Anktiva plus Bacillus Calmette-Guerin to provide durable bladder-sparing outcomes and a chemotherapy-free immunotherapy alternative for patients with high-risk papillary non-muscle invasive bladder cancer treatment, the company said.

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