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The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

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The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

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  • 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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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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