| | | A summary for me from Chat GPT5
Here’s the clean, “what’s approved vs. what’s pending” view for ANKTIVA (nogapendekin alfa inbakicept) in Europe:
What’s already approved - United Kingdom (UK) – Approved. The MHRA has granted marketing authorization for ANKTIVA + BCG to treat adult patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma-in-situ (CIS), with or without papillary tumors. This is a national UK approval (outside the EU system). Medscape+3GOV.UK+3ir.immunitybio.com+3
What’s pending / in process - European Union (EU/EEA) – Under active EMA review, not yet approved.
- ImmunityBio (IBRX) submitted an EU-wide Marketing Authorisation Application (MAA) for ANKTIVA + BCG in BCG-unresponsive NMIBC with CIS (± papillary tumors); the EMA accepted the MAA and began assessment earlier this year. ImmunityBio+2Nasdaq+2
- Current stage (October 2025): ANKTIVA appears on the CHMP (EMA) meeting agenda specifically under “Initial applications; List of outstanding issues (Day 180)”, with the action “For adoption.” The agenda also notes the “List of Questions adopted on 22.05.2025.” In plain English: reviewers issued their Day-120 questions in May; the October meeting is scheduled to adopt the Day-180 “List of Outstanding Issues” (LOI)—i.e., the remaining items EMA wants addressed before it can move to an opinion. European Medicines Agency (EMA)
- ANKTIVA also appears on the EMA’s public “applications under evaluation” list in the same CIS indication, confirming it’s in the pipeline. European Medicines Agency (EMA)
What “List of Questions” and “List of Outstanding Issues” mean - List of Questions (Day 120): the first round of substantive questions from EMA reviewers.
- List of Outstanding Issues (Day 180): the follow-up set of unresolved/remaining issues EMA wants the company to address. Adoption of an LOI is not a negative outcome; it’s a normal step in the centralized review. (The October CHMP agenda shows ANKTIVA at this LOI step.) European Medicines Agency (EMA)
So, in one sentence - UK: already approved for CIS (± papillary).
- EU: still under EMA review; ANKTIVA just advanced to the Day-180 “Outstanding Issues” stage at the October CHMP meeting. No EU approval yet. European Medicines Agency (EMA)+1
More details:
?? What IBRX (ImmunityBio) is trying to get through in Europe / UK
IBRX’s regulatory goal (in Europe / UK) is, broadly:
- Obtain marketing authorization for ANKTIVA + BCG in BCG-unresponsive NMIBC with CIS (with or without papillary tumors) — the same niche for which it is already approved in the U.S. (for CIS) and now approved in the UK for CIS. ImmunityBio+5Medthority+5Urology Times+5
- Possibly expand the indication further (e.g., papillary disease, beyond CIS) — IBRX has signaled such a plan in the U.S. (via supplemental BLA) and may later seek this in Europe too. Urology Times+3Urology Times+3ImmunityBio+3
- Manage or respond to “outstanding issues” (questions, clarifications) from the EMA and MHRA during review, which could include manufacturing, safety, clinical data, quality, bridging data, etc.
- Aim for eventual commercialization in EU/UK markets after regulatory approval.
A few more nuances:
- The MAA in the EU covers 30 countries (i.e. the 27 EU member states plus Iceland, Norway, Liechtenstein) per IBRX’s statements. ImmunityBio+1
- IBRX expects EMA’s assessment to be completed by Q4 2025. Similarly, the UK (MHRA) review is expected to complete by Q4 2025. ImmunityBio+3ImmunityBio+3ImmunityBio+3
- The company is in “continued dialog” with both agencies, responding to requests for additional information. ImmunityBio+2ImmunityBio+2
- If approved, the effective launch in EU markets might begin in 2026 (or late 2025 in some cases, depending on country-level pricing & reimbursement). ImmunityBio+2ImmunityBio+2
? Key Risks & Constraints to Watch
- Regulatory delays / outstanding issues: Like any novel biologic, EMA may issue List of Outstanding Issues (LOI) or questions to be answered by the sponsor. These can delay the approval or require data supplementation.
- Population / indication scope: The current MAA is for NMIBC with CIS (± papillary). If IBRX later wants a broader indication (e.g. “papillary only”), it will likely need to show additional data or meet more stringent endpoints.
- Country-by-country uptake: Even after an EU-level approval, each member state still must negotiate pricing, reimbursement, health technology assessments (HTA), and national regulatory formalities. That could delay availability in some markets.
- Manufacturing / CMC quality: A frequent source of regulatory friction especially for biologics. EMA may require inspections, validation data, stability, comparability, etc.
- Safety / long-term data: Regulators might demand longer follow-up, post-marketing commitments, or risk management plans, particularly given the immunotherapy / biologic nature.
- Regulatory standards / expectations differences: The EMA may have different standards of evidence, assay validation, bridging data (if U.S. data only), or requirements for European patient populations (e.g. diversity, ethnic consistency).
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