CDEK
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belantamab mafodotin

Trade name: TECVAYLI

mAbapprovedADCOrphan Drug FDABreakthrough Therapy FDA

Approved

Aug 5, 2020

Clinical trial activity

54 trials · 30 clinical orgs · 1 marketing orgs

Phase 1
26
Phase 2
48
Phase 3
11
Phase 4
0

Earliest trial started Oct 7, 2019 (NCT06160609)

Timeline

2010s

  1. Jun 22, 2017

    Orphan Drug Designation

  2. Jan 1, 2019

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2019

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2019

    GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)

2020s

  1. Aug 5, 2020

    GlaxoSmithKline — Earliest FDA Approval

  2. Aug 5, 2020

    GlaxoSmithKline — Marketing Organization

  3. Aug 5, 2020

    GlaxoSmithKline — NDA Secondary Org

  4. Aug 5, 2020

    GlaxoSmithKline — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughAug 5, 2020

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only
Multi-specific
No
Payload
Monomethylauristatin F

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07285239Phase 3May 31, 2026GlaxoSmithKline, Mayo Clinic, PrECOG, LLC.
NCT07227311Phase 2Jan 14, 2026GlaxoSmithKline
NCT07224672Phase 2Dec 1, 2025GlaxoSmithKline
NCT07019545Phase 2Jun 20, 2025Hellenic Society of Hematology
NCT06679101Phase 3Nov 28, 2024GlaxoSmithKline
NCT06232044Phase 1/Phase 2 (Phase 2)Aug 30, 2024National Cancer Institute (NCI)
NCT06413511Phase 1Jun 3, 2024GlaxoSmithKline
NCT05922501Phase 2Nov 30, 2023GlaxoSmithKline, Harvard University, Sanofi
NCT05874193Phase 2Nov 30, 2023Duke University
NCT05847569Phase 2Nov 27, 2023Mayo Clinic
NCT05853965Phase 1/Phase 2 (Phase 2)Jun 28, 2023University of Hamburg
NCT05714839Phase 1Jun 14, 2023GlaxoSmithKline
NCT05789303Phase 2May 30, 2023Amgen, GlaxoSmithKline, University of Chicago
NCT05493618Phase 1/Phase 2 (Phase 2)Dec 31, 2022Hackensack University Medical Center, Merck
NCT05573802Phase 1/Phase 2 (Phase 2)Oct 24, 2022GlaxoSmithKline, Hellenic Society of Hematology, National Kapodistrian University of Athens
NCT05581875Phase 1/Phase 2 (Phase 2)Oct 20, 2022GlaxoSmithKline, Hellenic Society of Hematology, National Kapodistrian University of Athens
NCT05461209Phase 3Oct 20, 2022—
NCT05556798Phase 1Oct 4, 2022Memorial Sloan-Kettering Cancer Center
NCT07150104Phase 1/Phase 2 (Phase 2)Aug 31, 2022GlaxoSmithKline
NCT05208307Phase 2Jul 21, 2022Emory University, GlaxoSmithKline, National Cancer Institute (NCI)
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (30)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit382332019
Hellenic Society of HematologyAcademic/Hospital5512021
National Kapodistrian University of AthensAcademic/Hospital4012021
Mayo ClinicAcademic/Hospital3222021
National Cancer Institute (NCI)Government3112021
University of Texas at HoustonAcademic/Hospital3322021
AmgenFor profit2012021
Clinica Universidad de NavarraAcademic/Hospital2012021
Harvard UniversityAcademic/Hospital2212020
PETHEMA FoundationAcademic/Hospital2212021
University of SalamancaAcademic/Hospital2012021
Adknoma Health ResearchFor profit1012021
Duke UniversityAcademic/Hospital1112023
Emory UniversityAcademic/Hospital1112022
European Myeloma NetworkAcademic/Hospital1112020
Hackensack University Medical CenterAcademic/Hospital1112022
Medical College of WisconsinAcademic/Hospital1112022
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112022
MerckFor profit1012022
PrECOG, LLC.Academic/Hospital1112026
30 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitMKTGAug 5, 2020
GlaxoSmithKlineFor profitNDA2Aug 5, 2020
GlaxoSmithKlineFor profitNDAAug 5, 2020
GlaxoSmithKlineFor profitSYNOct 23, 2025