Overview
- The CHMP issued a positive opinion on 11 December recommending a conditional marketing authorisation for Anktiva for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumours.
- The recommendation is supported by a single-arm, open-label phase 2/3 study showing a 71% complete response rate and a 26.6-month median duration of response.
- Anktiva is an IL-15 receptor agonist administered directly into the bladder together with BCG weekly for six weeks followed by maintenance therapy.
- EMA notes an unmet need in this setting in the EU, where no authorised therapies exist for disease unresponsive to BCG and bladder removal surgery is often the remaining option.
- The company must submit longer-term efficacy and safety data as a condition of approval, and EMA materials name ImmunityBio Ireland Limited and Serum Life Science Europe GmbH in applicant roles.