- Application covers 30 countries in the European Union
- Submission is based on the ongoing QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a 71% (71/100) complete response (CR) rate
- In these responders, the range of duration is 54 months and ongoing, exceeding all duration of response in approved products in this indication
Reno, Nevada (UroToday.com) -- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, announced the European Medicines Agency (EMA) has accepted for review and begun assessing the marketing authorization application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The EMA covers 27 countries in the European Union (EU), as well as Iceland, Norway and Liechtenstein.
“We are encouraged by the speed in which the EMA accepted our marketing authorization application and determined it would begin its assessment of our innovative treatment for this serious condition, just nine months after it was first approved by the FDA for use in the United States,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “Along with our submission to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), this action by the EMA is strong evidence of the momentum for putting ANKTIVA+BCG into the hands of physicians who are treating patients with NMIBC.”The EMA submission is based on the ongoing QUILT 3.032 study in which the complete response rate for the 100 evaluable patients in Cohort A as of the July 15, 2024 cut-off was 71%. In these responders, the range of duration of response is 0.03 to 54 months and is ongoing. These prolonged duration of complete response results beyond four years with ANKTIVA and BCG exceed the benchmark of 18 months for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group.
Source: ImmunityBio, Inc. (2024). ImmunityBio Announces European Medicines Agency Acceptance of Marketing Authorization Application for ANKTIVA® for the Treatment of Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ [Press release]. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-european-medicines-agency-acceptance?field_nir_news_date_value[min]