ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
Shots:
- The UK’s MHRA has approved Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS. MAA is under the EMA’s review & covers all 30 EEA states
- Approval was based on safety & efficacy data, incl. CR & DoR, from a single-arm trial in 77 pts treated with Anktiva + BCG, with some ongoing responses exceeding 47mos. as of the Nov 2023 cutoff
- Anktiva (IL-15 agonist IgG1 fusion complex) binds to IL-15 receptors to stimulate NK cell proliferation & memory killer T cell production, resulting in immunogenic apoptosis of tumor cells
Ref: Businesswire | Image: ImmunityBio | Press Release
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