TheraRadar

FDA Breakthrough Therapy Drug Approvals

141 novel drug approvals with the Breakthrough Therapy designation, 2016–2025.

Granted when preliminary clinical evidence suggests substantial improvement over existing therapies on a clinically significant endpoint. Comes with intensive FDA guidance throughout development.

Key insights (2016–2025)

  • • Breakthrough Therapy applies to 31% of all FDA novel drug approvals in this period (141 of 458 drugs).
  • • Activity fell 10% (16 → 14/year) in 2023–2025 vs 2020–2022. Peak year: 2020 with 21 approvals.
  • • 87 unique sponsors received this designation; the top sponsor is Roche (8 approvals). Top 5 sponsors account for 19% of all Breakthrough Therapy approvals.
  • • 91% of Breakthrough Therapy drugs also received Priority Review designation — the most common pairing.

Approvals by year

2016 7 2017 16 2018 14 2019 13 2020 21 2021 14 2022 13 2023 9 2024 18 2025 16

Top sponsors

Roche 8 Novartis 7 GSK 4 Gilead Sciences 4 Pfizer 4 Johnson & Johnson 4 Regeneron 4 AbbVie 3

All Breakthrough Therapy approvals

2025
AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (AVUTOMETINIB POTASSIUM) VERASTEM INC
2025
BLENREP (BELANTAMAB MAFODOTIN-BLMF) GSK
2025
EMRELIS (TELISOTUZUMAB VEDOTIN-TLLV) AbbVie
2025
HERNEXEOS (ZONGERTINIB) Boehringer Ingelheim
2025
HYRNUO (SEVABERTINIB) Bayer
2025
IBTROZI (TALETRECTINIB ADIPATE) NUVATION
2025
JASCAYD (NERANDOMILAST) Boehringer Ingelheim
2025
JOURNAVX (SUZETRIGINE) Vertex Pharmaceuticals
2025
KOMZIFTI (ZIFTOMENIB) KURA
2025
KYGEVVI (DOXECITINE) UCB INC
2025
MYQORZO (AFICAMTEN) CYTOKINETICS
2025
PENPULIMAB-KCQX AKESO BIOPHARMA
2025
REDEMPLO (PLOZASIRAN SODIUM) ARROWHEAD
2025
VOYXACT (SIBEPRENLIMAB-SZSI) OTSUKA
2025
YARTEMLEA (NARSOPLIMAB-WUUG) OMEROS CORP
2025
ZEGFROVY (SUNVOZERTINIB) DIZAL JIANGSU
2024
ANKTIVA (nogapendekin alfa inbakicept-pmln) ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
2024
BIZENGRI (ZENOCUTUZUMAB-ZBCO) MERUS N.V.
2024
CRENESSITY (CRINECERFONT) NEUROCRINE
2024
IMDELLTRA (TARLATAMAB-DLLE) Amgen
2024
IQIRVO (ELAFIBRANOR) IPSEN
2024
ITOVEBI (INAVOLISIB) Roche
2024
KISUNLA (DONANEMAB-AZBT) Eli Lilly
2024
LIVDELZI (SELADELPAR LYSINE) Gilead Sciences
2024
MIPLYFFA (ARIMOCLOMOL CITRATE) ZEVRA DENMARK
2024
NEMLUVIO (NEMOLIZUMAB-ILTO) GALDERMA LABS LP
2024
OJEMDA (TOVORAFENIB) DAY ONE BIOPHARMS
2024
REVUFORJ (REVUMENIB CITRATE) SYNDAX
2024
REZDIFFRA (RESMETIROM) MADRIGAL
2024
TRYNGOLZA (AUTOINJECTOR) (OLEZARSEN SODIUM) IONIS PHARMS INC
2024
VORANIGO (VORASIDENIB) SERVIER
2024
VOYDEYA (DANICOPAN) ALEXION PHARMS INC
2024
WINREVAIR (SOTATERCEPT-CSRK) Merck
2024
ZIIHERA (ZANIDATAMAB-HRII) JAZZ PHARMS
2023
ELREXFIO (ELRANATAMAB) Pfizer
2023
FABHALTA (IPTACOPAN HYDROCHLORIDE) Novartis
2023
IZERVAY (AVACINCAPTAD PEGOL SODIUM) ASTELLAS
2023
LEQEMBI (LECANEMAB-IRMB) EISAI INC
2023
LOQTORZI (TORIPALIMAB-TPZI) COHERUS BIOSCIENCES INC
2023
OGSIVEO (NIROGACESTAT HYDROBROMIDE) SPRINGWORKS
2023
POMBILITI (CIPAGLUCOSIDASE ALFA-ATGA) AMICUS THERAP US
2023
RIVFLOZA (NEDOSIRAN SODIUM) Novo Nordisk
2023
TALVEY (TALQUETAMAB-TGVS) Johnson & Johnson
2022
CAMZYOS (MAVACAMTEN) Bristol-Myers Squibb
2022
CIBINQO (ABROCITINIB) Pfizer
2022
ENJAYMO (SUTIMLIMAB-JOME) RECORDATI RARE DISEASES, INC.
2022
KIMMTRAK (TEBENTAFUSP-TEBN) IMMUNOCORE LTD
2022
KRAZATI (ADAGRASIB) Bristol-Myers Squibb
2022
LUNSUMIO (MOSUNETUZUMAB-AXGB) Roche
2022
LYTGOBI (FUTIBATINIB) TAIHO ONCOLOGY
2022
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) Novartis
2022
SPEVIGO (SPESOLIMAB-SBZO) Boehringer Ingelheim
2022
SUNLENCA (LENACAPAVIR SODIUM) Gilead Sciences
2022
TECVAYLI (TECLISTAMAB-CQYV) Johnson & Johnson
2022
TZIELD (TEPLIZUMAB-MZWV) PROVENTION BIO INC
2022
XENPOZYME (OLIPUDASE ALFA-RPCP) Sanofi
2021
COSELA (TRILACICLIB DIHYDROCHLORIDE) PHARMACOSMOS
2021
EVKEEZA (EVINACUMAB-DGNB) Regeneron
2021
EXKIVITY (MOBOCERTINIB SUCCINATE) Takeda
2021
JEMPERLI (DOSTARLIMAB-GXLY) GSK
2021
KORSUVA (DIFELIKEFALIN ACETATE) VIFOR INTL
2021
LIVMARLI (MARALIXIBAT CHLORIDE) MIRUM
2021
LIVTENCITY (MARIBAVIR) Takeda
2021
LUMAKRAS (SOTORASIB) Amgen
2021
NEXVIAZYME (AVALGLUCOSIDASE ALFA-NGPT) Sanofi
2021
NULIBRY (FOSDENOPTERIN HYDROBROMIDE) SENTYNL THERAPS INC
2021
REZUROCK (BELUMOSUDIL MESYLATE) KADMON PHARMS LLC
2021
RYBREVANT (AMIVANTAMAB-VMJW) Johnson & Johnson
2021
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) Novartis
2021
UKONIQ (UMBRALISIB TOSYLATE) TG THERAPS
2020
ARTESUNATE AMIVAS
2020
AYVAKIT (AVAPRITINIB) BLUEPRINT MEDICINES
2020
DANYELZA (NAXITAMAB-GQGK) Y-MABS THERAPEUTICS INC
2020
EBANGA (ANSUVIMAB-ZYKL) RIDGEBACK BIOTHERAPEUTICS
2020
ENSPRYNG (SATRALIZUMAB) Roche
2020
GAVRETO (PRALSETINIB) BLUEPRINT MEDICINES
2020
IMCIVREE (SETMELANOTIDE ACETATE) RHYTHM
2020
INMAZEB (ATOLTIVIMAB) Regeneron
2020
KOSELUGO (SELUMETINIB SULFATE) AstraZeneca
2020
MONJUVI (TAFASITAMAB-CXIX) MORPHOSYS US INC
2020
OXLUMO (LUMASIRAN SODIUM) ALNYLAM PHARMS INC
2020
PEMAZYRE (PEMIGATINIB) INCYTE CORP
2020
QINLOCK (RIPRETINIB) DECIPHERA PHARMS
2020
RETEVMO (SELPERCATINIB) Eli Lilly
2020
RUKOBIA (FOSTEMSAVIR TROMETHAMINE) VIIV HLTHCARE
2020
TABRECTA (CAPMATINIB HYDROCHLORIDE) Novartis
2020
TEPEZZA (TEPROTUMUMAB-TRBW) HORIZON THERAPEUTICS IRELAND
2020
TRODELVY (SACITUZUMAB GOVITECAN-HZIY) IMMUNOMEDICS INC
2020
TUKYSA (TUCATINIB) SEAGEN
2020
UPLIZNA (INEBILIZUMAB-CDON) VIELA BIO
2020
ZOKINVY (LONAFARNIB) SENTYNL THERAPS INC
2019
ADAKVEO (CRIZANLIZUMAB-TMCA) Novartis
2019
BALVERSA (ERDAFITINIB) Johnson & Johnson
2019
BRUKINSA (ZANUBRUTINIB) BEONE MEDICINES USA
2019
ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) DAIICHI SANKYO INC
2019
GIVLAARI (GIVOSIRAN SODIUM) ALNYLAM PHARMS INC
2019
OXBRYTA (VOXELOTOR) GLOBAL BLOOD THERAPS
2019
PADCEV (ENFORTUMAB VEDOTIN-EJFV) ASTELLAS
2019
POLIVY (POLATUZUMAB VEDOTIN-PIIQ) Roche
2019
ROZLYTREK (ENTRECTINIB) Roche
2019
TRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) Vertex Pharmaceuticals
2019
TURALIO (PEXIDARTINIB HYDROCHLORIDE) DAIICHI SANKYO INC
2019
VYNDAQEL (TAFAMIDIS MEGLUMINE) FOLDRX PHARMS
2019
ZULRESSO (BREXANOLONE) SAGE THERAP
2018
CRYSVITA (BUROSUMAB-TWZA) KYOWA KIRIN
2018
ELZONRIS (TAGRAXOFUSP-ERZS) STEMLINE THERAPEUTICS INC
2018
FIRDAPSE (AMIFAMPRIDINE PHOSPHATE) CATALYST PHARMS
2018
GAMIFANT (EMAPALUMAB-LZSG) NOVIMMUNE S.A.
2018
KRINTAFEL (TAFENOQUINE SUCCINATE) GSK
2018
LIBTAYO (CEMIPLIMAB-RWLC) Regeneron
2018
LORBRENA (LORLATINIB) Pfizer
2018
ONPATTRO (PATISIRAN SODIUM) ALNYLAM PHARMS INC
2018
OXERVATE (CENEGERMIN-BKBJ) DOMPE FARMACEUTICI
2018
POTELIGEO (MOGAMULIZUMAB-KPKC) KYOWA KIRIN
2018
SYMDEKO (COPACKAGED) (IVACAFTOR) Vertex Pharmaceuticals
2018
TAKHZYRO (LANADELUMAB-FLYO) DYAX CORP.
2018
TROGARZO (IBALIZUMAB-UIYK) THERATECHNOLOGIES
2018
VITRAKVI (LAROTRECTINIB SULFATE) Bayer
2017
ALUNBRIG (BRIGATINIB) Takeda
2017
BAVENCIO (AVELUMAB) EMD SERONO INC
2017
BESPONSA (INOTUZUMAB OZOGAMICIN) Pfizer
2017
BRINEURA (CERLIPONASE ALFA) BIOMARIN PHARM
2017
CALQUENCE (ACALABRUTINIB MALEATE) AstraZeneca
2017
DUPIXENT (DUPILUMAB) Regeneron
2017
HEMLIBRA (EMICIZUMAB) Roche
2017
IMFINZI (DURVALUMAB) AstraZeneca
2017
INGREZZA (VALBENAZINE TOSYLATE) NEUROCRINE
2017
KISQALI (RIBOCICLIB SUCCINATE) Novartis
2017
MAVYRET (GLECAPREVIR) AbbVie
2017
OCREVUS (OCRELIZUMAB) Roche
2017
PREVYMIS (LETERMOVIR) Merck
2017
RYDAPT (MIDOSTAURIN) Novartis
2017
VOSEVI (SOFOSBUVIR) Gilead Sciences
2017
ZEJULA (NIRAPARIB TOSYLATE) GSK
2016
EPCLUSA (SOFOSBUVIR) Gilead Sciences
2016
LARTRUVO (OLARATUMAB) Eli Lilly
2016
NUPLAZID (PIMAVANSERIN TARTRATE) ACADIA PHARMS INC
2016
RUBRACA (RUCAPARIB CAMSYLATE) PHARMAAND
2016
TECENTRIQ (ATEZOLIZUMAB) Roche
2016
VENCLEXTA (VENETOCLAX) AbbVie
2016
ZEPATIER (ELBASVIR) Merck

Other FDA designations

First-in-Class Orphan Drug Accelerated Approval Priority Review Fast Track

Designation data from FDA Center for Drug Evaluation and Research (CDER) annual New Drug Therapy Approvals reports, 2016–2025. Each drug is counted once per the year of its novel approval; many drugs hold multiple designations.

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