Advanced therapies authorised in the European Union

Dataset · Advanced therapies · European Union

Version 1.0 · census as at 2026-07-27 · one row per centralised marketing authorisation

This dataset lists every centralised marketing authorisation granted to an advanced therapy medicinal product in the European Union since 2009.

33 authorisations granted since 2009, 24 in force, 9 ended, 22 marketed. By category: 24 gene therapies, 5 somatic cell therapies, 4 tissue-engineered products.

Advanced therapies authorised in the European Union

Thirty-three centralised authorisations, from 2009 to July 2026.

Filters

2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 Gene therapy (24) Glybera Imlygic Strimvelis Yescarta Kymriah Luxturna Zynteglo Zolgensma Tecartus Libmeldy Skysona Abecma Breyanzi Carvykti Upstaza Roctavian Hemgenix Casgevy Beqvez (ex-Durveqtix) Vyjuvek Aucatzyl Waskyra Adstiladrin Itvisma Somatic cell therapy (5) Provenge Zalmoxis Alofisel Ebvallo Zemcelpro Tissue engineering (4) Chondrocelect MACI Holoclar Spherox
Marketed Authorised, not marketed Authorisation ended Bar = length of authorisation; cross = termination; arrow = still in force beyond the marker.
Authorisations
33 of 33
Ended
9 27 %
Median time to termination
38 months
Median pivotal sample
64 patients
Single-arm trials
24 73 %
Legend Marketed Authorised, not marketed Authorisation ended OOrphan at authorisation CConditional authorisation EExceptional circumstances
Product↕Category↕Authorised↕Pivotal trial↕n↕Status↕Duration↕Reason for exit↕
ChondrocelectChondrocytes autologues viables caractérisés, expansés ex vivo Tissue engineering 05/10/2009 Randomised controlled 118 Authorisation ended 82 Commercial
GlyberaAlipogène tiparvovec OEGene therapy 25/10/2012 Single-arm 27 Authorisation ended 60 Commercial
MACIChondrocytes autologues cultivés caractérisés appliqués sur matrice Tissue engineering 27/06/2013 Randomised controlled 144 Authorisation ended 60 Manufacturing
ProvengeSipuleucel-T Somatic cell therapy 06/09/2013 Randomised controlled 512 Authorisation ended 20 Commercial
HoloclarCellules épithéliales cornéennes autologues expansées ex vivo contenant des cellules souches OCTissue engineering 17/02/2015 Single-arm 104 Marketed ≥ 137 —
ImlygicTalimogène laherparepvec Gene therapy 16/12/2015 Randomised controlled 436 Marketed ≥ 127 —
StrimvelisFraction cellulaire CD34+ autologue transduite par vecteur rétroviral codant l'ADA OGene therapy 26/05/2016 Single-arm 12 Marketed ≥ 122 —
ZalmoxisLymphocytes T allogéniques génétiquement modifiés exprimant ΔLNGFR et HSV-TK Mut2 OCSomatic cell therapy 18/08/2016 Single-arm 30 Authorisation ended 38 Commercial
SpheroxSphéroïdes de chondrocytes autologues associés à une matrice Tissue engineering 10/07/2017 Randomised controlled 102 Marketed ≥ 109 —
AlofiselDarvadstrocel OSomatic cell therapy 23/03/2018 Randomised controlled 212 Authorisation ended 81 Efficacy
YescartaAxicabtagène ciloleucel OGene therapy 23/08/2018 Single-arm 111 Marketed ≥ 95 —
KymriahTisagenlecleucel OGene therapy 23/08/2018 Single-arm 92 Marketed ≥ 95 —
LuxturnaVorétigène néparvovec OGene therapy 22/11/2018 Randomised controlled 31 Marketed ≥ 92 —
ZyntegloBétibéglogène autotemcel OCGene therapy 29/05/2019 Single-arm 14 Authorisation ended 34 Commercial
ZolgensmaOnasemnogène abéparvovec OCGene therapy 18/05/2020 Single-arm 22 Marketed ≥ 74 —
TecartusBrexucabtagène autoleucel OCGene therapy 14/12/2020 Single-arm 74 Marketed ≥ 67 —
LibmeldyAtidarsagène autotemcel OGene therapy 17/12/2020 Single-arm 20 Marketed ≥ 67 —
SkysonaÉlivaldogène autotemcel OGene therapy 16/07/2021 Single-arm 32 Authorisation ended 4 Commercial
AbecmaIdécabtagène vicleucel OCGene therapy 18/08/2021 Single-arm 140 Marketed ≥ 59 —
BreyanziLisocabtagène maraleucel Gene therapy 04/04/2022 Single-arm — Marketed ≥ 52 —
CarvyktiCiltacabtagène autoleucel OCGene therapy 25/05/2022 Single-arm 113 Marketed ≥ 50 —
UpstazaÉladocagène exuparvovec OEGene therapy 18/07/2022 Single-arm 28 Marketed ≥ 48 —
RoctavianValoctocogène roxaparvovec OCGene therapy 24/08/2022 Single-arm 134 Authorised, not marketed ≥ 47 —
EbvalloTabélécleucel OESomatic cell therapy 16/12/2022 Single-arm 43 Marketed ≥ 43 —
HemgenixÉtranacogène dézaparvovec OCGene therapy 20/02/2023 Single-arm 54 Marketed ≥ 41 —
CasgevyExagamglogène autotemcel OCGene therapy 09/02/2024 Single-arm 42 Marketed ≥ 30 —
Beqvez (ex-Durveqtix)Fidanacogène élaparvovec CGene therapy 24/07/2024 Single-arm 45 Authorisation ended 10 Commercial
VyjuvekBérémagène géperpavec OGene therapy 23/04/2025 Randomised controlled 31 Marketed ≥ 15 —
AucatzylObécabtagène autoleucel CGene therapy 17/07/2025 Single-arm 94 Marketed ≥ 12 —
ZemcelproDorocubicel et cellules CD34- allogéniques de sang de cordon OCSomatic cell therapy 25/08/2025 Single-arm 25 Marketed ≥ 11 —
WaskyraÉtuvétidigène autotemcel OGene therapy 09/01/2026 Single-arm 10 Marketed ≥ 7 —
AdstiladrinNadofaragène firadénovec CGene therapy 28/05/2026 Single-arm 103 Marketed ≥ 2 —
ItvismaOnasemnogène abéparvovec (voie intrathécale) OGene therapy 30/06/2026 Randomised controlled 126 Status not established ≥ 1 —

Durations prefixed with ≥ are right-censored: the authorisation is still in force, so the observed duration is a minimum. These observations are excluded from the median time to termination, which covers observed exits only.

Below 5 observations, derived statistics are hidden: on so thin a sample, the named case is worth more than the average.

European Medicines Agency — European public assessment reports, register of authorisations, public withdrawal statements; European Commission union register; Official Journal of the European Union.

Counting conventions

A count with no stated convention means nothing. Those used here:

External consistency check. The 27 authorisations dated before 30 November 2024 correspond exactly to the count published by Frontiers in Medicine at that same date, withdrawals included.

Derived parameters

Of the nine observed exits: seven for commercial reasons, one for efficacy (Alofisel), one for manufacturing (MACI). Median time between grant and termination: 38 months, from 4 months (Skysona) to 82 months (Chondrocelect).

The crude 27 % exit rate is neither a five-year nor a seven-year risk: it mixes very unequal follow-up times. The Kaplan-Meier estimate gives 18 % at five years and 45 % at seven years (confidence interval 30 to 79 % at 82 months). Median survival is not reached. Numbers at risk: 33 at origin, 24 at 24 months, 18 at 48 months, 10 at 72 months, 4 at 96 months. Cumulative incidence by cause: commercial 18.1 % at 5 years and 31.8 % at 7 years; efficacy 7.8 %; manufacturing 5.8 %.

Across the 33 authorisations: 24 rest on a single-arm pivotal trial, for a median pivotal sample of 64 patients; 14 are conditional and 3 fall under exceptional circumstances.

Method and sources

Every row is established against: the product's European public assessment report, the register of authorisations, the Agency's public withdrawal statements, the decisions published in the Commission's union register and, for the most recent authorisation, the Official Journal of the European Union. The advanced therapy sub-category comes from the Committee's quarterly report, the only source that states it for all products.

Residual uncertainties

Fields that verification could not establish are flagged as such in the census file. They concern mainly Itvisma, whose assessment report is not yet published — authorisation type and pivotal data to be re-checked on publication; the exact pivotal sample of Breyanzi, not publicly established; the formal designation of the Spherox pivotal trial; and the sample size of Zemcelpro, given as 25 in the public summary and 36 in the assessment report.

Change log

Version Date Change
1.0 2026-07-27 Initial publication.