Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms |
Target |
Action inhibitors, stimulants |
Mechanism BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Relapse multiple myeloma | Phase 3 | Italy | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Canada | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Portugal | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Czechia | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Belgium | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Israel | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Turkey | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Hungary | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Spain | 19 May 2024 | |
Relapse multiple myeloma | Phase 3 | Australia | 19 May 2024 |
Phase 1 | Relapse multiple myeloma BCMA-positive | CD3 | - | (yizjzqelzi) = anemia (29%) ddqvpkqtoa (iwaupypzzr ) View more | - | 26 Sep 2023 | ||
NCT03933735 (Pubmed) Manual | Phase 1 | Relapse multiple myeloma Last line | 128 | (ESC+EXP) | (gpokjvpcjs) = eapcqbpiiw tuyrxuzpqk (huylnmiipk ) View more | Positive | 27 Aug 2022 |
(EXP) | (gpokjvpcjs) = vxhmqvsudw tuyrxuzpqk (huylnmiipk ) View more | ||||||
Phase 1 | 124 | snhwgmimuq(yhjynnidxq) = Among pts treated at 60mg (n=60; ESC+EXP), CRS occurred in 72% of the pts (48% G1; 22% G2; 2% G3) with the first dose, with median time to onset and resolution of 1 day (0% recurrence). Other AEs observed in >20% of all pts are fatigue (30%; G3-4, 1%), anemia (29%; G3-4, 16%), nausea (29%; G3-4, 2%), diarrhea (27%; G3-4, 2%), vomiting (24%; G3-4, 0%), and neutrophil count decreased (22%; G3-4, 19%) tztfnqddob (ajwwpijqmu ) View more | - | 25 Aug 2022 |