Same drug, different countries
246 approved and phase-3 products compared across six regulators. 97 are approved in all six regions, 31 are approved in the US but not the EU, and 9 are approved only in China. Filter by gap type to see where a pipeline exists in one region and is missing in another.
FDA
196 / 246
median lag 0 yrs
first-in-world 175 · missing 11
pending 42 · withdrawn/rejected 1
EMA
166 / 246
median lag 1 yr
first-in-world 62 · missing 41
pending 21 · withdrawn/rejected 3
MHRA
163 / 246
median lag 1 yr
first-in-world 52 · missing 44
pending 4
PMDA
135 / 246
median lag 2 yrs
first-in-world 21 · missing 72
pending 5
NMPA
126 / 246
median lag 4 yrs
first-in-world 15 · missing 81
pending 9
TGA
142 / 246
median lag 1 yr
first-in-world 15 · missing 65
pending 6
246 products
ApprovedConditionalUnder reviewNot filedWithdrawnRejected· blank = unknown
| Radioactive iodine (I-131) · Sodium iodide I-131 | Radiopharmaceutical (beta/gamma emitter, natural uptake) | 1951 | 1990 | 1990 | 1990 | 1990 | 1990 | 6/6 | 1951 US |
| Progestins (megestrol acetate, medroxyprogesterone, levonorgestrel IUD) · Megace; Mirena (IUD) | Hormonal therapy (progestin) | 1971 | 1970 | 1970 | 1980 | 1995 | 1975 | 6/6 | 1970 EU/UK |
| Doxorubicin · Adriamycin | Cytotoxic chemotherapy (anthracycline) | 1974 | 1971 | 1971 | 1975 | 1980 | 1975 | 6/6 | 1971 EU/UK |
| Tamoxifen · Nolvadex | Small-molecule SERM | 1977 | 1973 | 1973 | 1981 | 1990 | 1976 | 6/6 | 1973 EU/UK |
| Cisplatin · Platinol (generic) | Cytotoxic chemotherapy (platinum) | 1978 | 1979 | 1979 | 1983 | 1985 | 1980 | 6/6 | 1978 US |
| Ifosfamide · Ifex | Cytotoxic chemotherapy (alkylating agent) | 1988 | 1980 | 1980 | 1985 | 1990 | 1985 | 6/6 | 1980 EU/UK |
| Carboplatin | Cytotoxic chemotherapy (platinum) | 1989 | 1986 | 1986 | 1990 | 1990 | 1988 | 6/6 | 1986 EU/UK |
| Goserelin / leuprolide (ovarian function suppression) · Zoladex; Lupron | GnRH agonist | 1989 | 1987 | 1987 | 1991 | 1996 | 1990 | 6/6 | 1987 EU/UK |
| Somatostatin analogues (octreotide, lanreotide) · Sandostatin LAR, Somatuline Depot | Peptide hormone analogue (SSTR2 agonist) | 1988 | 1988 | 1988 | 1991 | 1996 | 1990 | 6/6 | 1988 US/EU/UK |
| Paclitaxel / nab-paclitaxel · Taxol / Abraxane | Cytotoxic chemotherapy (taxane) | 1992 | 1993 | 1993 | 1997 | 1995 | 1994 | 6/6 | 1992 US |
| Docetaxel · Taxotere (generic) | Cytotoxic chemotherapy (taxane) | 1996 | 1995 | 1995 | 1996 | 1996 | 1996 | 6/6 | 1995 EU/UK |
| Pegylated liposomal doxorubicin · Doxil / Caelyx | Cytotoxic (liposomal anthracycline) | 1995 | 1996 | 1996 | 2007 | 2003 | 1997 | 6/6 | 1995 US |
| Letrozole (and other aromatase inhibitors) · Femara; anastrozole (Arimidex); exemestane (Aromasin) | Small-molecule aromatase inhibitor | 1997 | 1996 | 1996 | 2006 | 2000 | 1997 | 6/6 | 1996 EU/UK |
| Topotecan · Hycamtin | Cytotoxic (topoisomerase-I inhibitor) | 1996 | 1996 | 1996 | 2000 | 2000 | 1998 | 6/6 | 1996 US/EU/UK |
| Rituximab · Rituxan / MabThera (and biosimilars) | Monoclonal antibody (anti-CD20, chimeric) | 1997 | 1998 | 1998 | 2001 | 2000 | 1998 | 6/6 | 1997 US |
| Trastuzumab · Herceptin (and biosimilars, Phesgo with pertuzumab) | Monoclonal antibody (anti-HER2) | 1998 | 2000 | 2000 | 2001 | 2002 | 2000 | 6/6 | 1998 US |
| Exemestane · Aromasin | Small-molecule steroidal aromatase inactivator | 1999 | 1999 | 1999 | 2002 | 2001 | 2000 | 6/6 | 1999 US/EU/UK |
| Gemtuzumab ozogamicin · Mylotarg | ADC | 2000 | 2018 | 2018 | 2005 | · | 2020 | 5/6 | 2000 US |
| Imatinib · Gleevec | Small-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA) | 2001 | 2001 | 2001 | 2001 | 2002 | 2001 | 6/6 | 2001 US/EU/UK/JP/AU |
| Fulvestrant · Faslodex | Injectable SERD | 2002 | 2004 | 2004 | 2011 | 2010 | 2004 | 6/6 | 2002 US |
| Bortezomib · Velcade | Proteasome inhibitor | 2003 | 2004 | 2004 | 2006 | 2005 | 2005 | 6/6 | 2003 US |
| Azacitidine · Vidaza / Onureg (oral) | Small-molecule hypomethylating agent (cytotoxic) | 2004 | 2008 | 2008 | 2011 | 2017 | 2009 | 6/6 | 2004 US |
| Bevacizumab · Avastin (and biosimilars) | Monoclonal antibody (anti-VEGF) | 2004 | 2005 | 2005 | 2007 | 2010 | 2005 | 6/6 | 2004 US |
| Cetuximab · Erbitux | Monoclonal antibody (anti-EGFR) | 2004 | 2004 | 2004 | 2008 | 2006 | 2005 | 6/6 | 2004 US/EU/UK |
| Pemetrexed · Alimta (and generics) | Cytotoxic (antifolate) | 2004 | 2004 | 2004 | 2007 | 2005 | 2004 | 6/6 | 2004 US/EU/UK/AU |
| Lenalidomide · Revlimid | Immunomodulatory drug (cereblon E3 ligase modulator) | 2005 | 2007 | 2007 | 2010 | 2013 | 2007 | 6/6 | 2005 US |
| Sorafenib · Nexavar | Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF) | 2005 | 2006 | 2006 | 2008 | 2006 | 2006 | 6/6 | 2005 US |
| Dasatinib · Sprycel | Small-molecule kinase inhibitor (BCR::ABL1, SRC) | 2006 | 2006 | 2006 | 2009 | 2011 | 2007 | 6/6 | 2006 US/EU/UK |
| Panitumumab · Vectibix | Monoclonal antibody (anti-EGFR) | 2006 | 2007 | 2007 | 2010 | 2021 | 2008 | 6/6 | 2006 US |
| Sunitinib · Sutent | Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, KIT) | 2006 | 2006 | 2006 | 2008 | 2007 | 2006 | 6/6 | 2006 US/EU/UK/AU |
| Lapatinib · Tykerb | Small-molecule reversible HER2/EGFR kinase inhibitor | 2007 | 2008 | 2008 | 2009 | 2013 | 2007 | 6/6 | 2007 US/AU |
| Trabectedin · Yondelis | Cytotoxic (DNA minor-groove binder) | 2015 | 2007 | 2007 | 2015 | · | 2010 | 5/6 | 2007 EU/UK |
| Bevacizumab (glioblastoma use) · Avastin | Monoclonal antibody (anti-VEGF) | 2009 | · | 2013 | · | 2010 | 3/6 | 2009 US | |
| Everolimus · Afinitor | Small-molecule mTOR inhibitor | 2009 | 2009 | 2009 | 2010 | 2013 | 2009 | 6/6 | 2009 US/EU/UK/AU |
| Pazopanib · Votrient | Small-molecule kinase inhibitor (VEGFR/PDGFR/KIT) | 2009 | 2010 | 2010 | 2012 | 2017 | 2010 | 6/6 | 2009 US |
| Cabazitaxel · Jevtana | Cytotoxic chemotherapy (taxane) | 2010 | 2011 | 2011 | 2014 | 2020 | 2011 | 6/6 | 2010 US |
| Abiraterone acetate · Zytiga (generic) | Small-molecule CYP17A1 inhibitor | 2011 | 2011 | 2011 | 2014 | 2015 | 2012 | 6/6 | 2011 US/EU/UK |
| Brentuximab vedotin · Adcetris | ADC | 2011 | 2012 | 2012 | 2014 | 2020 | 2013 | 6/6 | 2011 US |
| Ipilimumab · Yervoy | Monoclonal antibody (anti-CTLA-4) | 2011 | 2011 | 2011 | 2015 | 2021 | 2011 | 6/6 | 2011 US/EU/UK/AU |
| Optune / Optune Pax (TTFields) · Optune | Device (tumour treating fields) | 2011 | 2015 | · | 2016 | 2020 | · | 4/6 | 2011 US |
| Vandetanib · Caprelsa | Small-molecule kinase inhibitor (RET, VEGFR, EGFR) | 2011 | 2012 | 2012 | 2015 | · | 2013 | 5/6 | 2011 US |
| Vemurafenib · Zelboraf | Small-molecule kinase inhibitor (BRAF V600) | 2011 | 2012 | 2012 | 2014 | 2017 | 2012 | 6/6 | 2011 US |
| Axitinib · Inlyta | Small-molecule kinase inhibitor (VEGFR) | 2012 | 2012 | 2012 | 2012 | 2015 | 2012 | 6/6 | 2012 US/EU/UK/JP/AU |
| Cabozantinib · Cabometyx | Small-molecule multi-kinase inhibitor (MET, VEGFR2, AXL, RET) | 2012 | 2016 | 2016 | 2020 | 2023 | 2017 | 6/6 | 2012 US |
| Carfilzomib · Kyprolis | Proteasome inhibitor (irreversible) | 2012 | 2015 | 2015 | 2016 | 2021 | 2015 | 6/6 | 2012 US |
| Enzalutamide · Xtandi | Small-molecule AR antagonist | 2012 | 2013 | 2013 | 2014 | 2019 | 2014 | 6/6 | 2012 US |
| Pertuzumab · Perjeta; Phesgo (with trastuzumab, subcutaneous) | Monoclonal antibody (anti-HER2, dimerisation domain) | 2012 | 2013 | 2013 | 2013 | 2018 | 2013 | 6/6 | 2012 US |
| Ponatinib · Iclusig | Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | 2012 | 2013 | 2013 | 2016 | · | 2015 | 5/6 | 2012 US |
| Regorafenib · Stivarga | Small-molecule multi-kinase inhibitor | 2012 | 2013 | 2013 | 2013 | 2017 | 2013 | 6/6 | 2012 US |
| Dabrafenib + trametinib · Tafinlar + Mekinist | Small-molecule kinase inhibitors (BRAF + MEK) | 2013 | 2013 | 2013 | 2016 | 2019 | 2013 | 6/6 | 2013 US/EU/UK/AU |
| Ibrutinib · Imbruvica | Small-molecule covalent BTK inhibitor (first generation) | 2013 | 2014 | 2014 | 2016 | 2017 | 2015 | 6/6 | 2013 US |
| Obinutuzumab · Gazyva | Monoclonal antibody (anti-CD20, glycoengineered type II) | 2013 | 2014 | 2014 | 2018 | 2021 | 2014 | 6/6 | 2013 US |
| Radium-223 dichloride · Xofigo | Targeted alpha therapy (bone-seeking) | 2013 | 2013 | 2013 | 2016 | 2020 | 2014 | 6/6 | 2013 US/EU/UK |
| Trastuzumab emtansine · Kadcyla | ADC | 2013 | 2013 | 2013 | 2013 | 2020 | 2013 | 6/6 | 2013 US/EU/UK/JP/AU |
| Alectinib · Alecensa | Small-molecule kinase inhibitor (ALK) | 2015 | 2017 | 2017 | 2014 | 2018 | 2016 | 6/6 | 2014 JP |
| Blinatumomab · Blincyto | Bispecific T-cell engager (CD19×CD3) | 2014 | 2015 | 2015 | 2018 | 2020 | 2016 | 6/6 | 2014 US |
| Nivolumab · Opdivo / Opdivo Qvantig (SC) | Monoclonal antibody (anti-PD-1) | 2014 | 2015 | 2015 | 2014 | 2018 | 2016 | 6/6 | 2014 US/JP |
| Nonavalent HPV vaccine · Gardasil 9 | Prophylactic vaccine (virus-like particles) | 2014 | 2015 | 2015 | 2020 | 2018 | 2015 | 6/6 | 2014 US |
| Olaparib · Lynparza | Small-molecule PARP inhibitor | 2014 | 2014 | 2014 | 2018 | 2018 | 2016 | 6/6 | 2014 US/EU/UK |
| Pembrolizumab · Keytruda / Keytruda Qlex (SC) | Monoclonal antibody (anti-PD-1) | 2014 | 2015 | 2015 | 2016 | 2018 | 2015 | 6/6 | 2014 US |
| Ramucirumab · Cyramza | Monoclonal antibody (anti-VEGFR2) | 2014 | 2014 | 2014 | 2015 | 2022 | 2015 | 6/6 | 2014 US/EU/UK |
| Trifluridine/tipiracil · Lonsurf | Cytotoxic chemotherapy (oral nucleoside) | 2015 | 2016 | 2016 | 2014 | 2019 | 2018 | 6/6 | 2014 JP |
| Cobimetinib · Cotellic | Small-molecule kinase inhibitor (MEK1/2) | 2015 | 2015 | 2015 | 2018 | · | 2016 | 5/6 | 2015 US/EU/UK |
| Daratumumab · Darzalex / Darzalex Faspro (SC) | Monoclonal antibody (anti-CD38) | 2015 | 2016 | 2016 | 2017 | 2019 | 2016 | 6/6 | 2015 US |
| Dinutuximab (ch14.18) / dinutuximab beta · Unituxin / Qarziba (EU) | Monoclonal antibody (anti-GD2, chimeric) | 2015 | 2017 | 2017 | 2021 | · | 2020 | 5/6 | 2015 US |
| Lenvatinib · Lenvima | Small-molecule multi-kinase inhibitor (VEGFR, FGFR, PDGFR, RET, KIT) | 2015 | 2015 | 2015 | 2015 | 2018 | 2015 | 6/6 | 2015 US/EU/UK/JP/AU |
| Osimertinib · Tagrisso | Small-molecule kinase inhibitor (EGFR) | 2015 | 2016 | 2016 | 2016 | 2017 | 2016 | 6/6 | 2015 US |
| Palbociclib · Ibrance | Small-molecule CDK4/6 inhibitor | 2015 | 2016 | 2016 | 2017 | 2018 | 2017 | 6/6 | 2015 US |
| Talimogene laherparepvec · Imlygic | Oncolytic virus (HSV-1) | 2015 | 2015 | 2016 | · | · | 2016 | 4/6 | 2015 US/EU |
| Atezolizumab · Tecentriq / Tecentriq Hybreza (SC) | Monoclonal antibody (anti-PD-L1) | 2016 | 2017 | 2017 | 2018 | 2020 | 2017 | 6/6 | 2016 US |
| NALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV) · Onivyde regimen | Cytotoxic regimen | 2024 | 2016 | 2016 | · | · | 2018 | 4/6 | 2016 EU/UK |
| Rucaparib · Rubraca | Small-molecule PARP inhibitor | 2016 | 2018 | 2018 | · | · | 2020 | 4/6 | 2016 US |
| Venetoclax · Venclexta | Small-molecule BCL-2 inhibitor | 2016 | 2016 | 2016 | 2019 | 2020 | 2017 | 6/6 | 2016 US/EU/UK |
| Abemaciclib · Verzenio | Small-molecule CDK4/6 inhibitor | 2017 | 2018 | 2018 | 2018 | 2020 | 2019 | 6/6 | 2017 US |
| Acalabrutinib · Calquence | Small-molecule covalent BTK inhibitor (second generation) | 2017 | 2020 | 2020 | 2021 | 2023 | 2020 | 6/6 | 2017 US |
| Avelumab · Bavencio | Monoclonal antibody (anti-PD-L1) | 2017 | 2017 | 2017 | 2017 | 2020 | 2018 | 6/6 | 2017 US/EU/UK/JP |
| Axicabtagene ciloleucel · Yescarta | CAR-T (CD19) | 2017 | 2018 | 2018 | 2021 | 2021 | 2019 | 6/6 | 2017 US |
| CPX-351 (liposomal daunorubicin-cytarabine) · Vyxeos | Liposomal cytotoxic formulation | 2017 | 2018 | 2018 | 2024 | · | 2021 | 5/6 | 2017 US |
| Durvalumab · Imfinzi | Monoclonal antibody (anti-PD-L1) | 2017 | 2018 | 2018 | 2018 | 2019 | 2018 | 6/6 | 2017 US |
| Enasidenib · Idhifa | Small-molecule IDH2 inhibitor | 2017 | 2021 | · | · | · | 1/6 | 2017 US | |
| FoundationOne CDx / Liquid CDx | Comprehensive genomic profiling test | 2017 | 2019 | · | 2018 | · | · | 3/6 | 2017 US |
| Inotuzumab ozogamicin · Besponsa | ADC | 2017 | 2017 | 2017 | 2018 | 2021 | 2018 | 6/6 | 2017 US/EU/UK |
| Lutetium-177 dotatate · Lutathera | Radioligand therapy (beta) | 2018 | 2017 | 2018 | 2021 | 2024 | 2018 | 6/6 | 2017 EU |
| Midostaurin · Rydapt | Small-molecule multikinase inhibitor (FLT3) | 2017 | 2017 | 2017 | 2019 | 2021 | 2017 | 6/6 | 2017 US/EU/UK/AU |
| Neratinib · Nerlynx | Small-molecule irreversible pan-HER kinase inhibitor | 2017 | 2018 | 2018 | · | · | 2019 | 4/6 | 2017 US |
| Niraparib · Zejula | Small-molecule PARP inhibitor | 2017 | 2017 | 2017 | 2020 | 2019 | 2018 | 6/6 | 2017 US/EU/UK |
| Ribociclib · Kisqali | Small-molecule CDK4/6 inhibitor | 2017 | 2017 | 2017 | 2019 | 2023 | 2017 | 6/6 | 2017 US/EU/UK/AU |
| Tisagenlecleucel · Kymriah | CAR-T (CD19) | 2017 | 2018 | 2018 | 2019 | 2018 | 5/6 | 2017 US | |
| Tivozanib · Fotivda | Small-molecule kinase inhibitor (VEGFR) | 2021 | 2017 | 2017 | · | · | · | 3/6 | 2017 EU/UK |
| Trastuzumab biosimilars · Ogivri, Herzuma, Kanjinti, Trazimera, Ontruzant, Hercessi | Biosimilar monoclonal antibody (anti-HER2) | 2017 | 2017 | 2018 | 2018 | 2020 | 2018 | 6/6 | 2017 US/EU |
| Apalutamide · Erleada | Small-molecule AR antagonist | 2018 | 2019 | 2019 | 2019 | 2019 | 2018 | 6/6 | 2018 US/AU |
| Binimetinib · Mektovi | Small-molecule kinase inhibitor (MEK1/2) | 2018 | 2018 | 2018 | 2019 | · | 2019 | 5/6 | 2018 US/EU/UK |
| Cemiplimab · Libtayo | Monoclonal antibody (anti-PD-1) | 2018 | 2019 | 2019 | 2024 | · | 2020 | 5/6 | 2018 US |
| Encorafenib · Braftovi | Small-molecule kinase inhibitor (BRAF) | 2018 | 2018 | 2018 | 2019 | 2023 | 2019 | 6/6 | 2018 US/EU/UK |
| Fruquintinib · Fruzaqla | Small-molecule kinase inhibitor (VEGFR1-3) | 2023 | 2024 | 2024 | 2024 | 2018 | 2025 | 6/6 | 2018 CN |
| Gilteritinib · Xospata | Small-molecule kinase inhibitor (FLT3, type I) | 2018 | 2019 | 2019 | 2018 | 2021 | 2019 | 6/6 | 2018 US/JP |
| Ivosidenib · Tibsovo | Small-molecule IDH1 inhibitor | 2018 | 2023 | 2023 | · | 2022 | 2023 | 5/6 | 2018 US |
| Lorlatinib · Lorbrena | Small-molecule kinase inhibitor (ALK/ROS1) | 2018 | 2019 | 2019 | 2018 | 2022 | 2019 | 6/6 | 2018 US/JP |
| Pyrotinib · Airuini | Small-molecule irreversible pan-HER kinase inhibitor | · | · | · | 2018 | · | 1/6 | 2018 CN | |
| Tagraxofusp · Elzonris | Recombinant cytotoxin (IL-3 fused to diphtheria toxin) | 2018 | 2021 | 2021 | · | · | · | 3/6 | 2018 US |
| Talazoparib · Talzenna | Small-molecule PARP inhibitor | 2018 | 2019 | 2019 | 2023 | 2021 | 2019 | 6/6 | 2018 US |
| Toripalimab · Loqtorzi | Monoclonal antibody (anti-PD-1) | 2023 | 2024 | 2025 | · | 2018 | 2025 | 5/6 | 2018 CN |
| Alpelisib · Piqray | Small-molecule PI3Kα inhibitor | 2019 | 2020 | 2020 | 2022 | 2024 | 2020 | 6/6 | 2019 US |
| Camrelizumab · AiRuiKa | Monoclonal antibody (anti-PD-1) | · | · | 2019 | · | 1/6 | 2019 CN | ||
| Darolutamide · Nubeqa | Small-molecule AR antagonist | 2019 | 2020 | 2020 | 2020 | 2021 | 2020 | 6/6 | 2019 US |
| Enfortumab vedotin · Padcev | ADC | 2019 | 2022 | 2022 | 2021 | 2023 | 5/6 | 2019 US | |
| Erdafitinib · Balversa | Small-molecule kinase inhibitor (pan-FGFR) | 2019 | 2024 | 2024 | 2024 | · | 2025 | 5/6 | 2019 US |
| Polatuzumab vedotin · Polivy | ADC | 2019 | 2020 | 2020 | 2021 | 2023 | 2020 | 6/6 | 2019 US |
| Quizartinib · Vanflyta | Small-molecule kinase inhibitor (FLT3-ITD, type II) | 2023 | 2023 | 2024 | 2019 | 2025 | · | 5/6 | 2019 JP |
| Relugolix · Orgovyx | Oral GnRH antagonist | 2020 | 2022 | 2022 | 2019 | · | 2023 | 5/6 | 2019 JP |
| Selinexor · Xpovio | Small-molecule XPO1 (nuclear export) inhibitor | 2019 | 2021 | 2021 | · | 2021 | 2022 | 5/6 | 2019 US |
| Tislelizumab · Tevimbra | Monoclonal antibody (anti-PD-1) | 2024 | 2023 | 2024 | 2025 | 2019 | 2024 | 6/6 | 2019 CN |
| Trastuzumab deruxtecan · Enhertu | ADC | 2019 | 2021 | 2021 | 2020 | 2023 | 2022 | 6/6 | 2019 US |
| Zanubrutinib · Brukinsa | Small-molecule covalent BTK inhibitor (second generation) | 2019 | 2021 | 2021 | 2021 | 2020 | 2020 | 6/6 | 2019 US |
| Avapritinib · Ayvakit | Small-molecule kinase inhibitor (PDGFRA D842V / KIT) | 2020 | 2020 | 2020 | · | 2021 | 2022 | 5/6 | 2020 US/EU/UK |
| Belantamab mafodotin · Blenrep | ADC | 2020 | 2025● | 2025 | 2025 | 2025 | 5/6 | 2020 US | |
| Capmatinib & tepotinib · Tabrecta / Tepmetko | Small-molecule kinase inhibitors (MET) | 2020 | 2022 | 2022 | 2020 | 2023 | 2021 | 6/6 | 2020 US/JP |
| Cetuximab sarotalocan · Akalux | Photoimmunotherapy conjugate (anti-EGFR antibody–IR700 dye) | · | · | 2020 | · | · | 1/6 | 2020 JP | |
| Decitabine + cedazuridine (oral) · Inqovi | Oral hypomethylating agent | 2020 | 2023 | 2023 | · | · | 2022 | 4/6 | 2020 US |
| Gallium-68 gozetotide (PSMA-11) · Illuccix / Gozellix / Locametz | PET imaging agent | 2020 | 2022 | 2022 | · | · | 2021 | 4/6 | 2020 US |
| Isatuximab · Sarclisa / Sarclisa Escena (SC) | Monoclonal antibody (anti-CD38) | 2020 | 2020 | 2020 | 2020 | 2022 | 2020 | 6/6 | 2020 US/EU/UK/JP/AU |
| Lurbinectedin · Zepzelca | Cytotoxic (transcription inhibitor) | 2020 | · | · | · | 2023 | 2/6 | 2020 US | |
| Margetuximab · Margenza | Fc-engineered monoclonal antibody (anti-HER2) | 2020 | 2022 | · | · | 2024 | · | 2/6 | 2020 US |
| Naxitamab · Danyelza | Monoclonal antibody (anti-GD2, humanised) | 2020 | · | · | 2024 | · | 2/6 | 2020 US | |
| Pemigatinib · Pemazyre | Small-molecule kinase inhibitor (FGFR1-3) | 2020 | 2021 | 2021 | 2021 | 2022 | 2022 | 6/6 | 2020 US |
| Pralsetinib · Gavreto | Small-molecule kinase inhibitor (RET) | 2020 | 2021 | 2021 | · | 2021 | 2022 | 5/6 | 2020 US |
| Ripretinib · Qinlock | Small-molecule kinase inhibitor (KIT/PDGFRA switch-control) | 2020 | 2021 | 2021 | · | 2021 | 2020 | 5/6 | 2020 US/AU |
| Sacituzumab govitecan · Trodelvy | ADC | 2020 | 2021 | 2021 | 2024 | 2022 | 2022 | 6/6 | 2020 US |
| Selpercatinib · Retevmo | Small-molecule kinase inhibitor (RET) | 2020 | 2021 | 2021 | 2021 | 2022 | 2021 | 6/6 | 2020 US |
| Tafasitamab · Monjuvi | Monoclonal antibody (anti-CD19, Fc-enhanced) | 2020 | 2021 | 2021 | · | · | 2022 | 4/6 | 2020 US |
| Tucatinib · Tukysa | Small-molecule kinase inhibitor (HER2) | 2020 | 2021 | 2021 | · | 2023 | 2021 | 5/6 | 2020 US |
| Amivantamab · Rybrevant | Bispecific antibody (EGFR×MET) | 2021 | 2021 | 2022 | 2024 | 2024 | 2023 | 6/6 | 2021 US/EU |
| Asciminib · Scemblix | Small-molecule allosteric ABL1 inhibitor (STAMP) | 2021 | 2022 | 2022 | 2022 | 2023 | 2022 | 6/6 | 2021 US |
| Belzutifan · Welireg | Small-molecule HIF-2α inhibitor | 2021 | 2025● | 2025 | 2025 | · | 2025 | 5/6 | 2021 US |
| Disitamab vedotin | ADC | · | · | · | 2021 | · | 1/6 | 2021 CN | |
| Dostarlimab · Jemperli | Monoclonal antibody (anti-PD-1) | 2021 | 2021 | 2021 | · | · | 2023 | 4/6 | 2021 US/EU/UK |
| Idecabtagene vicleucel · Abecma | CAR-T (BCMA) | 2021 | 2021 | 2021 | 2022 | · | 2022 | 5/6 | 2021 US/EU/UK |
| Lisocabtagene maraleucel · Breyanzi | CAR-T (CD19, defined CD4:CD8) | 2021 | 2022 | 2022 | 2021 | · | 2022 | 5/6 | 2021 US/JP |
| Loncastuximab tesirine · Zynlonta | ADC | 2021 | 2022 | 2023 | · | 2025 | · | 4/6 | 2021 US |
| Piflufolastat F-18 / Pylarify TruVu · Pylarify | PET imaging agent | 2021 | 2023 | 2023 | · | · | · | 3/6 | 2021 US |
| Sotorasib · Lumakras | Small-molecule inhibitor (KRAS G12C) | 2021 | 2022 | 2021 | 2022 | 2022 | 5/6 | 2021 US/UK | |
| Tisotumab vedotin · Tivdak | ADC | 2021 | 2025● | 2025 | 2024 | · | · | 4/6 | 2021 US |
| Adagrasib · Krazati | Small-molecule inhibitor (KRAS G12C) | 2022 | 2024● | 2024 | · | 2024 | 4/6 | 2022 US | |
| Cadonilimab · Kaitanni | Bispecific antibody (PD-1×CTLA-4) | · | · | · | 2022 | · | 1/6 | 2022 CN | |
| Ciltacabtagene autoleucel · Carvykti | CAR-T (BCMA) | 2022 | 2022 | 2022 | 2022 | 2024 | 2023 | 6/6 | 2022 US/EU/UK/JP |
| Futibatinib · Lytgobi | Small-molecule irreversible kinase inhibitor (FGFR1-4) | 2022 | 2023 | 2023 | 2023 | · | · | 4/6 | 2022 US |
| Lutetium-177 vipivotide tetraxetan · Pluvicto | Radioligand therapy (beta) | 2022 | 2022 | 2023 | 2025 | 2023 | 5/6 | 2022 US/EU | |
| Mirvetuximab soravtansine · Elahere | ADC | 2022 | 2024● | 2025 | 3/6 | 2022 US | |||
| Mosunetuzumab · Lunsumio | Bispecific T-cell engager (CD20×CD3) | 2022 | 2022 | 2022 | 2024 | · | 2023 | 5/6 | 2022 US/EU/UK |
| Nadofaragene firadenovec · Adstiladrin | Non-replicating adenoviral gene therapy (intravesical) | 2022 | 2026● | · | · | · | 2/6 | 2022 US | |
| Olutasidenib · Rezlidhia | Small-molecule IDH1 inhibitor | 2022 | · | · | · | · | 1/6 | 2022 US | |
| Relatlimab + nivolumab · Opdualag | Fixed-dose bispecific combination (anti-LAG-3 + anti-PD-1) | 2022 | 2022 | 2023 | · | · | 2023 | 4/6 | 2022 US/EU |
| Serplulimab · Hansizhuang / Hetronifly | Monoclonal antibody (anti-PD-1) | 2025 | 2025 | · | 2022 | · | 3/6 | 2022 CN | |
| Tebentafusp · Kimmtrak | ImmTAC (TCR×CD3 bispecific) | 2022 | 2022 | 2022 | · | 2023 | 4/6 | 2022 US/EU/UK | |
| Teclistamab · Tecvayli | Bispecific T-cell engager (BCMA×CD3) | 2022 | 2022 | 2022 | 2024 | 2025 | 2024 | 6/6 | 2022 US/EU/UK |
| Tremelimumab · Imjudo | Monoclonal antibody (anti-CTLA-4) | 2022 | 2023 | 2023 | 2022 | · | 2023 | 5/6 | 2022 US/JP |
| Camrelizumab + rivoceranib | PD-1 antibody + oral VEGFR2 inhibitor | · | · | · | 2023 | · | 1/6 | 2023 CN | |
| Capivasertib · Truqap | Small-molecule AKT inhibitor | 2023 | 2024● | 2024 | 2024 | 2025 | 2024 | 6/6 | 2023 US |
| Eflornithine (DFMO) · Iwilfin | Small-molecule ornithine decarboxylase inhibitor | 2023 | · | · | · | · | 1/6 | 2023 US | |
| Elacestrant · Orserdu | Oral SERD | 2023 | 2023 | 2024 | · | 2024 | 4/6 | 2023 US/EU | |
| Elranatamab · Elrexfio | Bispecific T-cell engager (BCMA×CD3) | 2023 | 2023 | 2024 | 2024 | · | 2024 | 5/6 | 2023 US/EU |
| Epcoritamab · Epkinly | Bispecific T-cell engager (CD20×CD3) | 2023 | 2023 | 2023 | 2023 | · | 2024 | 5/6 | 2023 US/EU/UK/JP |
| Flotufolastat F-18 · Posluma | PET imaging agent | 2023 | · | · | · | · | 1/6 | 2023 US | |
| Glofitamab · Columvi | Bispecific T-cell engager (CD20×CD3, 2:1) | 2023 | 2023 | 2023 | 2024 | 2024 | 2024 | 6/6 | 2023 US/EU/UK |
| Nirogacestat · Ogsiveo | Small-molecule gamma-secretase inhibitor | 2023 | 2025 | 2025 | · | · | · | 3/6 | 2023 US |
| Pirtobrutinib · Jaypirca | Small-molecule non-covalent (reversible) BTK inhibitor | 2023 | 2023 | 2024 | 2025 | · | · | 4/6 | 2023 US/EU |
| Repotrectinib · Augtyro | Small-molecule kinase inhibitor (ROS1 / NTRK) | 2023 | 2025● | 2025 | 2024 | 2025 | · | 5/6 | 2023 US |
| Talquetamab · Talvey | Bispecific T-cell engager (GPRC5D×CD3) | 2023 | 2023 | 2024 | 2025 | · | 2024 | 5/6 | 2023 US/EU |
| Afamitresgene autoleucel · Tecelra | TCR-T (MAGE-A4) | 2024 | · | · | · | · | 1/6 | 2024 US | |
| Inavolisib · Itovebi | Small-molecule PI3Kα inhibitor and degrader | 2024 | 2025● | 2025 | 2025 | 2025 | 5/6 | 2024 US | |
| Ivonescimab | Bispecific antibody (PD-1×VEGF) | · | · | 2024 | · | 1/6 | 2024 CN | ||
| Lazertinib · Lazcluze | Small-molecule kinase inhibitor (EGFR) | 2024 | 2025● | 2025 | 2025 | 2025 | · | 5/6 | 2024 US |
| Lifileucel · Amtagvi | TIL cell therapy | 2024 | 2025 | · | 1/6 | 2024 US | |||
| Nogapendekin alfa inbakicept · Anktiva | IL-15 superagonist (intravesical, with BCG) | 2024 | 2026● | 2025 | · | · | · | 3/6 | 2024 US |
| Obecabtagene autoleucel · Aucatzyl | CAR-T (CD19, fast off-rate) | 2024 | 2025● | 2025 | · | · | · | 3/6 | 2024 US |
| Odronextamab · Lynozyfic (EU: Ordspono) | Bispecific T-cell engager (CD20×CD3) | 2025 | 2024 | 2025 | · | · | · | 3/6 | 2024 EU |
| Revumenib · Revuforj | Small-molecule menin inhibitor | 2024 | · | · | · | · | 1/6 | 2024 US | |
| Sacituzumab tirumotecan | ADC | · | · | 2024 | · | 1/6 | 2024 CN | ||
| Shield | Blood-based colorectal cancer screening test | 2024 | · | · | · | · | 1/6 | 2024 US | |
| Tarlatamab · Imdelltra | Bispecific T-cell engager (DLL3×CD3) | 2024 | · | 2025 | · | 2/6 | 2024 US | ||
| Tovorafenib · Ojemda | Small-molecule type II RAF inhibitor | 2024 | 2026 | 2026 | · | · | · | 3/6 | 2024 US |
| Vorasidenib · Voranigo | Small-molecule IDH1/2 inhibitor | 2024 | 2025● | 2025 | · | 2025 | 4/6 | 2024 US | |
| Zanidatamab · Ziihera | Biparatopic bispecific antibody (HER2) | 2024 | 2025● | 2025 | · | 2025 | · | 4/6 | 2024 US |
| Zenocutuzumab · Bizengri | Bispecific antibody (HER2×HER3) | 2024 | · | · | · | · | 1/6 | 2024 US | |
| Zolbetuximab · Vyloy | Monoclonal antibody (anti-Claudin 18.2) | 2024 | 2024● | 2024 | 2024 | 2025 | 2025 | 6/6 | 2024 US/EU/UK/JP |
| ArteraAI Prostate | AI digital pathology prognostic/predictive test | 2025 | · | · | · | · | · | 1/6 | 2025 US |
| Avutometinib + defactinib · Avmapki Fakzynja Co-Pack | Small-molecule RAF/MEK clamp + FAK inhibitor | 2025 | · | · | · | · | 1/6 | 2025 US | |
| Datopotamab deruxtecan · Datroway | ADC | 2025 | 2025● | 2025 | 2025 | 4/6 | 2025 US/EU/UK/JP | ||
| Dordaviprone · Modeyso | Small-molecule imipridone (ClpP agonist / DRD2 antagonist) | 2025 | · | · | · | · | 1/6 | 2025 US | |
| Gemcitabine intravesical system (TAR-200) · Inlexzo | Intravesical drug-eluting device | 2025 | · | · | · | · | 1/6 | 2025 US | |
| Imlunestrant · Inluriyo | Oral SERD | 2025 | 2026● | 2026 | 2026 | · | · | 4/6 | 2025 US |
| Linvoseltamab · Lynozyfic | Bispecific T-cell engager (BCMA×CD3) | 2025 | 2025● | 2025 | · | · | · | 3/6 | 2025 US/EU/UK |
| Satricabtagene autoleucel | CAR-T (Claudin 18.2) | · | · | · | 2025 | · | 1/6 | 2025 CN | |
| Sevabertinib · Hyrnuo | Small-molecule kinase inhibitor (HER2) | 2025 | · | · | · | · | 1/6 | 2025 US | |
| Sonrotoclax · Beqalzi | Small-molecule BCL-2 inhibitor (second generation) | 2026 | · | · | · | 2025 | · | 2/6 | 2025 CN |
| Telisotuzumab vedotin · Emrelis | ADC | 2025 | · | · | · | · | 1/6 | 2025 US | |
| Trastuzumab rezetecan | ADC | · | · | · | · | 2025 | · | 1/6 | 2025 CN |
| Vimseltinib · Romvimza | Small-molecule kinase inhibitor (CSF1R) | 2025 | · | · | · | · | 1/6 | 2025 US | |
| Ziftomenib · Komzifti | Small-molecule menin inhibitor | 2025 | · | · | · | · | 1/6 | 2025 US | |
| Zongertinib · Hernexeos | Small-molecule kinase inhibitor (HER2) | 2025 | · | · | 2025 | · | 2/6 | 2025 US/CN | |
| ArteraAI Breast | AI digital pathology risk test | 2026 | · | · | · | · | · | 1/6 | 2026 US |
| Camizestrant · Etcamah | Oral SERD | 2026 | · | · | · | · | 1/6 | 2026 US | |
| Gedatolisib · Revtorpyk | Small-molecule pan-PI3K/mTOR inhibitor | 2026 | · | · | · | · | 1/6 | 2026 US | |
| Relacorilant · Lifyorli | Small-molecule glucocorticoid receptor antagonist | 2026 | · | · | · | · | 1/6 | 2026 US | |
| Vepdegestrant · Veppanu | PROTAC oestrogen receptor degrader | 2026 | · | · | · | · | 1/6 | 2026 US | |
| Vusolimogene oderparepvec · Tudriqev | Oncolytic virus (HSV-1) | 2026 | · | · | · | · | 1/6 | 2026 US | |
| Zidesamtinib · Jideytro | Small-molecule kinase inhibitor (ROS1) | 2026 | · | · | · | · | 1/6 | 2026 US | |
| 177Lu-edotreotide | Radioligand therapy (beta) | · | · | · | · | 0/6 | — | ||
| 177Lu-PSMA-I&T | Radioligand therapy (beta) | · | · | · | · | 0/6 | — | ||
| Actinium-225 DOTATATE | Targeted alpha therapy | · | · | · | · | · | 0/6 | — | |
| Actinium-225 PSMA agents | Targeted alpha therapy | · | · | · | · | · | 0/6 | — | |
| Anitocabtagene autoleucel | CAR-T (BCMA, D-domain binder) | · | · | · | · | · | 0/6 | — | |
| ARX788 | ADC | · | · | · | · | · | 0/6 | — | |
| Atirmociclib | Small-molecule CDK4-selective inhibitor | · | · | · | · | · | 0/6 | — | |
| Bemarituzumab | Monoclonal antibody (anti-FGFR2b) | · | · | · | · | 0/6 | — | ||
| BGB-16673 | Small-molecule BTK degrader (CDAC) | · | · | · | · | · | 0/6 | — | |
| Brenetafusp | ImmTAC (PRAME TCR × CD3 bispecific) | · | · | · | · | · | 0/6 | — | |
| Cretostimogene grenadenorepvec | Oncolytic adenovirus (intravesical) | · | · | · | · | · | 0/6 | — | |
| Daraxonrasib · Rasonque | Small-molecule pan-RAS(ON) inhibitor | · | · | · | · | · | 0/6 | — | |
| DCVax-L | Autologous dendritic cell vaccine (tumour lysate) | · | · | · | · | 0/6 | — | ||
| Divarasib | Small-molecule inhibitor (KRAS G12C) | · | · | · | · | · | 0/6 | — | |
| Fianlimab | Monoclonal antibody (anti-LAG-3) | · | · | · | · | · | 0/6 | — | |
| Ficerafusp alfa | Bifunctional antibody (EGFR × TGF-β trap) | · | · | · | · | · | 0/6 | — | |
| Galleri | Multi-cancer early detection blood test | · | · | · | 0/6 | — | |||
| Giredestrant | Oral SERD | · | · | · | · | · | 0/6 | — | |
| Golcadomide | Molecular glue degrader (CELMoD, IKZF1/3) | · | · | · | · | · | 0/6 | — | |
| Iberdomide | CELMoD (cereblon E3 ligase modulator) | · | · | · | · | · | 0/6 | — | |
| Ifinatamab deruxtecan | ADC | · | · | · | · | · | 0/6 | — | |
| Intismeran autogene | Personalised mRNA neoantigen vaccine | · | · | · | · | · | 0/6 | — | |
| Izalontamab brengitecan | Bispecific ADC | · | · | · | · | 0/6 | — | ||
| Luveltamab tazevibulin | ADC | · | · | · | · | · | 0/6 | — | |
| Mevrometostat | Small-molecule EZH2 inhibitor | · | · | · | · | · | 0/6 | — | |
| Mezigdomide | CELMoD (cereblon E3 ligase modulator) | · | · | · | · | · | 0/6 | — | |
| Neladalkib | Small-molecule kinase inhibitor (ALK) | · | · | · | · | · | 0/6 | — | |
| Nemtabrutinib | Small-molecule non-covalent BTK inhibitor | · | · | · | · | · | 0/6 | — | |
| Olomorasib | Small-molecule inhibitor (KRAS G12C) | · | · | · | · | · | 0/6 | — | |
| Pasritamig | Bispecific T-cell engager (KLK2×CD3) | · | · | · | · | · | 0/6 | — | |
| Patritumab deruxtecan | ADC | 2025 | · | · | · | · | · | 0/6 | — |
| Petosemtamab | Bispecific antibody (EGFR × LGR5) | · | · | · | · | · | 0/6 | — | |
| Raludotatug deruxtecan | ADC | · | · | · | · | · | 0/6 | — | |
| Rinatabart sesutecan | ADC | · | · | · | · | · | 0/6 | — | |
| Sonesitatug vedotin | ADC | · | · | · | · | 0/6 | — | ||
| Tinengotinib | Small-molecule multi-kinase inhibitor (FGFR1-3, VEGFR, Aurora, JAK) | · | · | · | · | 0/6 | — | ||
| Trastuzumab brengitecan | ADC | · | · | · | · | · | 0/6 | — | |
| Xaluritamig | Bispecific T-cell engager (STEAP1×CD3, XmAb 2+1) | · | · | · | · | · | 0/6 | — | |
| Zilovertamab vedotin | ADC | · | · | · | · | · | 0/6 | — |
Approval lag by region
Years between the first approval anywhere and approval in each region, across products approved in that region. Zero means the region was among the first to approve.
| Region | Regulator | Approved | Median lag | Mean lag | First-in-world | Missing | Pending |
|---|---|---|---|---|---|---|---|
| United States | FDA | 196 | 0 yr | 0.3 yr | 175 | 11 | 42 |
| European Union | EMA / European Commission | 166 | 1 yr | 1.4 yr | 62 | 41 | 21 |
| United Kingdom | MHRA (NICE for reimbursement) | 163 | 1 yr | 1.5 yr | 52 | 44 | 4 |
| Japan | PMDA / MHLW | 135 | 2 yr | 3.0 yr | 21 | 72 | 5 |
| China | NMPA | 126 | 4 yr | 4.4 yr | 15 | 81 | 9 |
| Australia | TGA (PBS for reimbursement) | 142 | 1 yr | 2.1 yr | 15 | 65 | 6 |
How to read this
Each cell is the regulator’s decision for the product in that region: the year of first oncology approval, a tick for full approval, ✓c for conditional or accelerated approval, … for a filing under review, a dash where the sponsor has said it will not file, and ✕ for a withdrawn or rejected application. A dot means we have no sourced record, which is not the same as “not approved”.
“First” is the earliest year of approval in any of the six regions and the region(s) that granted it. Lag is measured in whole years against that first approval. “Missing” counts products approved somewhere but not in the region.
Regions: US = FDA, EU = EMA / European Commission, UK = MHRA (NICE for reimbursement), JP = PMDA / MHLW, CN = NMPA, AU = TGA (PBS for reimbursement). UK entries reflect MHRA marketing authorisation, not NICE reimbursement; Australian entries reflect TGA registration, not PBS listing.
Sourcing caveat
US entries are seeded from the product corpus, which cites FDA approval notices. EU entries link to the EMA public assessment report; a small filled dot on a cell marks rows checked directly against the EPAR page. UK, Japan, China and Australia entries link to regulator search pages or company releases and are stated at year resolution only. Years for legacy chemotherapies predate online registers and are approximate.
This matrix is a work in progress. Approvals happen weekly, indications differ between regions even when a product is approved in both, and a missing cell most often means we have not yet sourced it. Verify at the regulator before relying on any cell. Corrections are welcome via the repo.