{
  "last_checked": "2026-10-29",
  "license": "CC BY 4.0. Credit: ProteinIQ, https://proteiniq.io/guides/fda-approved-adcs",
  "sources": {
    "fda": "FDA Purple Book October 2026 download (latest approval October 27, 2026); CDER Novel Drug Approvals for 2026",
    "ema": "EMA medicines report generated October 29, 2026",
    "nmpa": {
      "disitamab vedotin": "RemeGen HKEX inside information announcement, June 9, 2021",
      "sacituzumab tirumotecan": "Kelun-Biotech announcement, November 27, 2024",
      "trastuzumab rezetecan": "Hengrui announcement, May 2025",
      "trastuzumab botidotin": "Kelun-Biotech announcement, October 17, 2025",
      "becotatug vedotin": "Lepu Biopharma HKEX inside information announcement, October 30, 2025",
      "izalontamab brengitecan": "NMPA approval June 22, 2026, reported by BioPharm International, June 23, 2026"
    }
  },
  "fda": {
    "approved_ever": 15,
    "currently_licensed": 15,
    "withdrawn_then_reapproved": [
      "Mylotarg",
      "Blenrep"
    ],
    "by_first_approval_year": {
      "2000": 1,
      "2011": 1,
      "2013": 1,
      "2017": 1,
      "2019": 3,
      "2020": 2,
      "2021": 2,
      "2022": 1,
      "2025": 2,
      "2026": 1
    },
    "year_end": [
      {
        "year": 2000,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2001,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2002,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2003,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2004,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2005,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2006,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2007,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2008,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2009,
        "approved_ever": 1,
        "available": 1
      },
      {
        "year": 2010,
        "approved_ever": 1,
        "available": 0
      },
      {
        "year": 2011,
        "approved_ever": 2,
        "available": 1
      },
      {
        "year": 2012,
        "approved_ever": 2,
        "available": 1
      },
      {
        "year": 2013,
        "approved_ever": 3,
        "available": 2
      },
      {
        "year": 2014,
        "approved_ever": 3,
        "available": 2
      },
      {
        "year": 2015,
        "approved_ever": 3,
        "available": 2
      },
      {
        "year": 2016,
        "approved_ever": 3,
        "available": 2
      },
      {
        "year": 2017,
        "approved_ever": 4,
        "available": 4
      },
      {
        "year": 2018,
        "approved_ever": 4,
        "available": 4
      },
      {
        "year": 2019,
        "approved_ever": 7,
        "available": 7
      },
      {
        "year": 2020,
        "approved_ever": 9,
        "available": 9
      },
      {
        "year": 2021,
        "approved_ever": 11,
        "available": 11
      },
      {
        "year": 2022,
        "approved_ever": 12,
        "available": 11
      },
      {
        "year": 2023,
        "approved_ever": 12,
        "available": 11
      },
      {
        "year": 2024,
        "approved_ever": 12,
        "available": 11
      },
      {
        "year": 2025,
        "approved_ever": 14,
        "available": 14
      },
      {
        "year": 2026,
        "approved_ever": 15,
        "available": 15
      }
    ],
    "by_target": {
      "HER2": 2,
      "TROP2": 2,
      "CD33": 1,
      "CD30": 1,
      "CD22": 1,
      "CD79b": 1,
      "Nectin-4": 1,
      "BCMA": 1,
      "CD19": 1,
      "Tissue factor": 1,
      "Folate receptor alpha": 1,
      "c-Met": 1,
      "CD123": 1
    },
    "by_payload_class": {
      "Microtubule inhibitor (auristatin)": 6,
      "Topoisomerase I inhibitor": 3,
      "DNA-cleaving (calicheamicin)": 2,
      "Microtubule inhibitor (maytansinoid)": 2,
      "DNA cross-linker (pyrrolobenzodiazepine dimer)": 1,
      "DNA alkylator (indolinobenzodiazepine)": 1
    },
    "by_linker_type": {
      "Cleavable": 13,
      "Non-cleavable": 2
    },
    "through_2025": 14
  },
  "ema": {
    "authorised_ever": 13,
    "currently_authorised": 13
  },
  "worldwide_fda_ema_nmpa": {
    "approved_ever": 21,
    "china_only": [
      "disitamab vedotin",
      "sacituzumab tirumotecan",
      "trastuzumab rezetecan",
      "trastuzumab botidotin",
      "becotatug vedotin",
      "izalontamab brengitecan"
    ],
    "by_target": {
      "HER2": 5,
      "TROP2": 3,
      "CD33": 1,
      "CD30": 1,
      "CD22": 1,
      "CD79b": 1,
      "Nectin-4": 1,
      "BCMA": 1,
      "CD19": 1,
      "Tissue factor": 1,
      "Folate receptor alpha": 1,
      "c-Met": 1,
      "CD123": 1,
      "EGFR": 1,
      "EGFR x HER3 (bispecific)": 1
    },
    "by_payload_class": {
      "Microtubule inhibitor (auristatin)": 9,
      "Topoisomerase I inhibitor": 6,
      "DNA-cleaving (calicheamicin)": 2,
      "Microtubule inhibitor (maytansinoid)": 2,
      "DNA cross-linker (pyrrolobenzodiazepine dimer)": 1,
      "DNA alkylator (indolinobenzodiazepine)": 1
    },
    "by_linker_type": {
      "Cleavable": 19,
      "Non-cleavable": 2
    }
  },
  "related_conjugates_not_counted": {
    "Lumoxiti": "Immunotoxin",
    "Zevalin": "Radioimmunoconjugate",
    "Bexxar": "Radioimmunoconjugate",
    "Akalux": "Photoimmunoconjugate"
  }
}