Shots:
- The EMA has recommended conditional EU marketing authorization for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC carcinoma in situ.
- Recommendation was based on safety and efficacy data in 100 adults, showing a 71% CR rate, with responses lasting a median of ~27 mos and extending up to 54+ mos; CR rates among responders were 66% at 12 mos and 42% at 24 mos. ImmunityBio will continue post-marketing follow-up to submit long-term safety and efficacy data to the EMA.
- ANKTIVA is an IL-15 receptor agonist indicated with BCG for adults with BCG-unresponsive NMIBC CIS, with or without papillary tumors
Ref: ImmunityBio | Image: ImmunityBio| Press Release
Related News:- ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
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