Tacquell (Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded)

Where it stands

Tacquell (autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded) is not authorised in the EU. The Netherlands Cancer Institute is the applicant. The CHMP adopted a negative opinion on 25 June 2026, and the records show the EU marketing authorisation as refused on 14 September 2026. No approval date is recorded.

The proposed indication was adult patients with unresectable stage IIIC to IV melanoma after prior anti-PD-1-based checkpoint inhibitor treatment. That prior treatment could have been given as first-line therapy for unresectable stage III or IV disease, or as (neo)adjuvant therapy.

The records do not state the CHMP's grounds for the negative opinion, so the reasons for refusal (efficacy, safety, quality or a combination) cannot be assessed from this dataset. The public assessment documents would be the place to look for them.

Regulatory pathway and designations

The records show two steps: a CHMP negative opinion, then an EU refusal of the marketing authorisation. This matches the usual centralised procedure, in which the CHMP opinion goes to the European Commission, which issues the legally binding decision. Here that decision was a refusal. The records do not say which procedural route or product classification applied. An autologous, ex vivo-expanded cell product would normally be handled as an advanced therapy, but the records do not confirm this.

No designations are recorded. The records show no orphan, PRIME or conditional-authorisation status, and none should be assumed. They also do not say whether accelerated assessment was used.

In general, an applicant can ask the CHMP to re-examine a negative opinion within a short statutory window after receiving it. The records do not say whether this happened. The only recorded outcome is the refusal on 14 September 2026.

Safety and pharmacovigilance

The records contain no safety data, no risk management plan details and no information on adverse events, so no product-specific safety assessment can be made here.

As a general point, a refused product has no EU marketing authorisation. The post-authorisation obligations that apply to marketed products, such as periodic safety update reports and routine signal detection in EU pharmacovigilance systems, therefore do not apply to Tacquell as a licensed medicine. Safety oversight of any continuing clinical or named-patient use would sit under the rules and sponsors responsible for that use. The records say nothing about whether such use exists.

What to watch

The main item is the published CHMP assessment report and any related public documents. These would show the deficiencies behind the negative opinion and whether they concern clinical evidence, benefit-risk or manufacturing. The records do not cover this.

Also worth watching is whether the applicant announces a new submission, further data or another regulatory route. None of this is in the records, so any expectation would be speculation. Professionals tracking the post-PD-1 melanoma setting should treat Tacquell as having no EU authorisation, based on the refusal recorded on 14 September 2026.