The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Shots:
- The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK’s MHRA
- As of the data cut-off on Jul 15, 2024, the study showed a 71% CR rate for 100 evaluable patients in Cohort A. In these responders, DoR range was as long as 54mos. & ongoing
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
Related News:- ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)
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