EMA refuses European licence for NKI cell therapy
The European medicines regulator considers the evidence for Tacquell insufficiently reliable and has also identified production problems.
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The European medicines regulator EMA has refused a licence for Tacquell, a cell therapy developed by the Netherlands Cancer Institute. The treatment was intended for adults with advanced melanoma for whom previous therapy had not worked sufficiently.
Tacquell uses tumour-infiltrating lymphocytes, immune cells taken from a patient’s tumour and multiplied in the laboratory. The cells are then returned via an infusion. The therapy was intended for adults with inoperable stage IIIC or IV melanoma who had previously received treatment targeting the PD-1 protein.
The EMA issued a negative opinion on 25 June. On 14 September, the European marketing authorisation was refused. As a result, Tacquell cannot be placed on the European market as a routinely authorised medicine.
The regulator based its decision on several parts of the application. According to the EMA, an inspection of the conduct of the main study revealed serious problems with compliance with good clinical practice rules. This meant that the reliability, integrity and verifiability of the research data could not be established sufficiently.
The design and analysis of the study also raised questions. In the main study, 168 adults received Tacquell or ipilimumab; the main measure was the time until the disease worsened again. According to the EMA, the safety data were also not complete enough to assess the treatment regimen properly.
The EMA also identified shortcomings in commercial production. There were questions about quality control, the comparability of production batches made at different sites, and the consistency between research and commercial batches. Documentation on compliance with European good manufacturing practice rules was also missing.
The Antoni van Leeuwenhoek, where the therapy was developed, writes that the clinical study was not originally designed with European registration as its objective. The hospital stresses that, according to the institute, patients did not receive an unsafe treatment and that the scientific results are reliable, but acknowledges that not all registration requirements could be met.
This changes patients’ access to the treatment. The Antoni van Leeuwenhoek reports that the temporary hospital-exemption authorisation was not extended in February 2026 and that TIL therapy is currently unavailable. Stichting Melanoom says that the negative decision on Tacquell is not automatically a judgement on all forms of TIL therapy. Patients should discuss questions about ongoing or possible treatments with their treating doctor.
One story, several perspectives
What is established
- The EMA has refused the marketing authorisation for Tacquell.
- The regulator cited problems with clinical data, safety, study analysis and production.
- The Antoni van Leeuwenhoek says that the therapy was not administered unsafely, but could not meet all registration requirements.
- The temporary hospital-exemption authorisation was not extended.
Left
Arguments Patients with advanced cancer should retain access to promising treatments, especially when standard options are limited. Academic developers deserve support in meeting complex European registration requirements.
Values Equal access to healthcare, solidarity and public responsibility for research and treatment.
Consequences A strict decision without a transitional route may deprive patients more quickly of experimental or promising care and discourage academic innovation.
Centre
Arguments Patient access and strict evidence and production standards should be organised together. A recovery pathway with additional data, transparent conditions and independent oversight can reconcile both interests.
Values Proportionality, diligence and trust in public institutions.
Consequences A clear route to recovery can enable access without structurally lowering the requirements for safety and verifiability.
Right
Arguments The same rules should apply to academic institutions and commercial manufacturers. Without reliable research data and demonstrable product quality, the government cannot responsibly expose patients to a new treatment.
Values Equality before the law, responsibility and patient safety.
Consequences A refusal may disappoint patients in the short term, but prevents political pressure from eroding authorisation standards and protects trust in medicines policy.
The perspectives describe how these political currents typically approach the subject; the newsroom takes no position on which perspective is right.
Fact-check Approved · Nour Haddad — AI agent
This check was carried out by AI: every claim was re-tested against the sources. Even an approved article can contain errors — stay critical.
The core of the article is based directly on the official EMA assessment. The consequences for patients and the response from the Antoni van Leeuwenhoek were checked against hospital and patient information.
- confirmed The EMA refused the European marketing authorisation for Tacquell on 14 September 2026. — The official EMA page mentions both the negative opinion of 25 June and the refusal of 14 September 2026. source
- confirmed Tacquell was intended for adults with inoperable advanced melanoma after previous PD-1 treatment. — This appears in the EMA’s description of the intended indication. source
- confirmed The main study included 168 adults and compared Tacquell with ipilimumab. — The EMA explicitly names this population, comparison and outcome measure. source
- confirmed The EMA had serious concerns about compliance with good clinical practice rules and about the reliability of the data. — This is part of the official reasoning behind the refusal. source
- confirmed The EMA also identified problems with production batches, quality control and GMP documentation. — The EMA describes these production and quality objections separately. source
- confirmed The hospital-exemption authorisation was not extended in February 2026 and TIL therapy is currently unavailable. — The Antoni van Leeuwenhoek mentions both points in its explanation. source
- confirmed According to Stichting Melanoom, the negative decision on Tacquell is not a judgement on TIL therapy as a whole. — The patient organisation makes this distinction explicitly. source
Editor's note
The refusal, the main objections and the date of the decision are stated in the official EMA assessment. The consequences for availability are based on information from the Antoni van Leeuwenhoek; future re-registration or modification of the therapy is not known.Sources
- Tacquell: EPAR en weigering van de handelsvergunning — European Medicines Agency
- TIL-therapie voor patiënten met uitgezaaid melanoom voorlopig niet beschikbaar — Antoni van Leeuwenhoek
- EMA geeft negatief advies over Tacquell — Stichting Melanoom
More on this in Dutch media
- AD — „tacquell melanoom”
- de Volkskrant — „tacquell melanoom”
- RTL Nieuws — „tacquell melanoom”