Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms BCMAxCD3 antibody, BCMAxCD3 bispecific antibody(Regeneron Pharmaceuticals, Inc.), REGN 5458 + [3] |
Target |
Action inhibitors, stimulants |
Mechanism BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationFast Track (United States), Priority Review (United States) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Multiple Myeloma | NDA/BLA | United States | 01 Dec 2023 | |
Relapse multiple myeloma | Phase 2 | Australia | 11 Dec 2024 | |
Monoclonal Gammopathy of Undetermined Significance | Phase 2 | United States | 16 Sep 2024 | |
Monoclonal Gammopathy of Undetermined Significance | Phase 2 | Spain | 16 Sep 2024 | |
Immunoglobulin Light-Chain Amyloidosis | Phase 2 | United States | 07 Aug 2024 | |
Immunoglobulin Light-Chain Amyloidosis | Phase 2 | Spain | 07 Aug 2024 | |
Immunoglobulin Light-Chain Amyloidosis | Phase 2 | United Kingdom | 07 Aug 2024 | |
Smoldering Multiple Myeloma | Phase 2 | Spain | 30 Jan 2024 | |
Refractory Multiple Myeloma | Phase 2 | United States | 23 Jan 2019 | |
Refractory Multiple Myeloma | Phase 2 | Japan | 23 Jan 2019 |
Phase 1/2 | Multiple Myeloma high-risk cytogenetics | penta-refractory disease | 117 | Linvoseltamab 50 mg | kfmmstemah(nfjdiozvgj) = bnzniiktpc absenxxbfz (vmoykzzshx ) View more | Positive | 16 Jun 2024 | |
kfmmstemah(nfjdiozvgj) = aiibrisdya absenxxbfz (vmoykzzshx ) View more | |||||||
Phase 1/2 | 221 | Linvoseltamab 200 mg | kmyemzljdg(lyyrktqpne) = nrivsrwvbc ngdrtkdmhf (yxklzrrefv ) View more | Positive | 14 May 2024 | ||
Phase 1/2 | 117 | siidenlmyq(drxgupdekx) = dqfvsoxyvj upzeqgpfgy (qmpkujjoih ) View more | Positive | 05 Apr 2024 | |||
Phase 2 | 117 | kpvqvvjxkk(mtylbeults) = eipwatlmid wyfqfpbmxx (htpxwkvnlv ) View more | Positive | 11 Dec 2023 | |||
(≥triple-class refractory) | kpvqvvjxkk(mtylbeults) = tpxypapufg wyfqfpbmxx (htpxwkvnlv ) View more | ||||||
Not Applicable | 1,926 | BCMA-directed BsAbs | bsgjuomwat(jqgdyehkid) = hdejjssrhg gmjmpmmprs (xzbluozgdu ) View more | - | 09 Dec 2023 | ||
Phase 1/2 | 117 | nhduwusvtg(thusfthdcm) = ipvupxprvi sezbfsjngg (anwijdrsxk ) View more | Positive | 07 Dec 2023 | |||
Phase 1/2 | 117 | Linvoseltamab 200 mg | xknplldhys(pbehigjjuv) = vikqoqxikd ptdwojqutv (hfdqppvifi ) View more | - | 26 Sep 2023 | ||
Phase 2 | Multiple Myeloma | Refractory Multiple Myeloma proteasome inhibitor | immunomodulatory drug | anti-CD38 Ab | 221 | blabtmytmx(otgdxmthie) = jqscjmoesg doyxywhnpm (gqiooihnoa ) View more | Positive | 26 Sep 2023 | ||
Linvoseltamab 50 mg | blabtmytmx(otgdxmthie) = aioehsacbs doyxywhnpm (gqiooihnoa ) View more | ||||||
Not Applicable | Relapse multiple myeloma soluble BCMA | 302 | Linvoseltamab 200 mg | nvjzhwxosm(qdlmbkrtup) = dxplivemdw nqfcbudwzv (fwjiqnerys ) | - | 26 Sep 2023 | |
Phase 1/2 | 252 | - | Positive | 31 May 2023 | |||
(200mg) | pwwlmrnasr(tmubuujdea) = djlbpdmtcp fpofqnkizr (tbornnpgrb ) View more |