Overview
- Anktiva plus BCG received conditional marketing authorization from the European Commission for adults with BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ, the first immunotherapy cleared in Europe for this setting.
- The authorization covers all 27 EU member states plus Iceland, Norway and Liechtenstein, expanding Anktiva’s footprint to 33 countries across four regulatory jurisdictions.
- The EU clearance is supported by QUILT‑3.032 results showing a 71% complete response rate, a 26.6‑month median duration of response, and 84% of responders cystectomy‑free at 36 months, with ongoing data reporting required.
- In the U.S., regulators have outlined a supplemental filing path for papillary NMIBC that does not require new trials, and the company is preparing the requested materials.
- ImmunityBio continues to build its platform with a new Phase 2 study in indolent B‑cell lymphoma and an amended $505 million convertible note allowing earlier equity conversion, as H.C. Wainwright raised its price target to $10.