{"entity":{"id":"tacquell","kind":"drug","name":"Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes)","aka":["Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded"],"tldr":"Tacquell is a tumour-infiltrating lymphocyte therapy for melanoma developed by the Netherlands Cancer Institute, the academic group whose randomised trial first showed TIL therapy could beat ipilimumab. Europe's medicines committee gave it a negative opinion in June 2026, so it is not authorised.","summary":"Tacquell (EMA product number EMEA/H/C/006563; marketing authorisation applicant Netherlands Cancer Institute) is described in the EMA register as autologous melanoma-derived tumour-infiltrating lymphocytes, ex vivo expanded, for the treatment of melanoma. The CHMP adopted its opinion on 25 June 2026 and the opinion status on the product page is negative, so there is no EU marketing authorisation. It is an academic TIL product; the linked key paper is the Netherlands Cancer Institute's randomised phase 3 trial of TIL therapy against ipilimumab (NCT02278887). The only other TIL product with a regulatory history in the corpus is lifileucel (Amtagvi), whose EU application was withdrawn in 2025.","asOf":"2026-09-22","links":[{"label":"EMA: Tacquell (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tacquell"}],"tags":["ema-register"],"related":["lifileucel","ipilimumab"],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["til-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["nki"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-rohaas-til-vs-ipilimumab-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo content wave 5 (EMA medicines register and EPAR pages)","editedOn":"2026-09-22"},"brand":"Tacquell","modality":"TIL cell therapy (autologous tumour-infiltrating lymphocytes, ex vivo expanded)","mechanism":"A patient's own tumour-infiltrating lymphocytes are taken from a melanoma deposit, expanded outside the body and returned; the EMA's committee adopted a negative opinion on the application for melanoma (EMA product page).","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-06-25","type":"crl","region":"EU","note":"CHMP negative opinion on Tacquell (autologous TIL) for melanoma; applicant Netherlands Cancer Institute","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/tacquell"}]},"route":"/drugs/tacquell/","neighbours":{"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"}],"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}],"institution":[{"id":"nki","kind":"institution","name":"Netherlands Cancer Institute (NKI-AvL)","route":"/institutions/nki/"}],"paper":[{"id":"paper-rohaas-til-vs-ipilimumab-nejm-2022","kind":"paper","name":"Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma","route":"/key-papers/paper-rohaas-til-vs-ipilimumab-nejm-2022/"}]}}