Drug Type Monoclonal antibody |
Synonyms Daratumumab (Genetical Recombination), 达雷木单抗, JNJ-54767414 + [6] |
Target |
Action inhibitors |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (16 Nov 2015), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10777 | Daratumumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Immunoglobulin Light-Chain Amyloidosis | European Union | 20 May 2016 | |
Immunoglobulin Light-Chain Amyloidosis | Iceland | 20 May 2016 | |
Immunoglobulin Light-Chain Amyloidosis | Liechtenstein | 20 May 2016 | |
Immunoglobulin Light-Chain Amyloidosis | Norway | 20 May 2016 | |
Multiple Myeloma | United States | 16 Nov 2015 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Smoldering Multiple Myeloma | NDA/BLA | European Union | 08 Nov 2024 | |
Residual Neoplasm | Phase 3 | United States | 26 Apr 2019 | |
Residual Neoplasm | Phase 3 | Canada | 26 Apr 2019 | |
Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Belgium | 10 Oct 2017 |
Phase 2 | 80 | (Cohort A) | boeixhkbwf = ykizughqru yherqousrp (sejjatkhvy, gpzfrxlhwp - laklqczmtw) View more | - | 04 Jun 2025 | ||
(Cohort B) | boeixhkbwf = ippdspxrwb yherqousrp (sejjatkhvy, uuxhplbffp - flgaxtmmbx) View more | ||||||
Not Applicable | 804 | kupztfxuvf(iryoohpkgs) = ahoglcrgmy rekvqgnygw (ajbslljwgf ) View more | Positive | 30 May 2025 | |||
kupztfxuvf(iryoohpkgs) = wjuasmudiu rekvqgnygw (ajbslljwgf ) View more | |||||||
Phase 2 | 28 | plfxflabpk(nxhddodckt) = xvomwrsshh fhoceivglh (kuyqehsypb ) View more | Positive | 30 May 2025 | |||
plfxflabpk(nxhddodckt) = uzivnliryk fhoceivglh (kuyqehsypb ) | |||||||
Phase 3 | 419 | (Arm A: Standard Therapy: PVd or DPd) | trtvagtwnd(wymyfyiolv) = ilmtctohbt zzzctyoyas (rdtthjtqdn, fnktbywsgf - tlqysdtbkv) View more | - | 20 May 2025 | ||
Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])) | trtvagtwnd(wymyfyiolv) = whtbxqawrx zzzctyoyas (rdtthjtqdn, adfamxqqcu - dcewrdwkox) View more | ||||||
Phase 2 | Multiple Myeloma Maintenance | 22 | txmecuokgt(zsjcqljova) = jekgmdjfuo yvidavpocq (egavxyabxf ) View more | Positive | 14 May 2025 | ||
txmecuokgt(zsjcqljova) = amvgazxkgo yvidavpocq (egavxyabxf ) | |||||||
Not Applicable | Immunoglobulin Light-Chain Amyloidosis First line NTproBNP | high-sensitivity troponin T | myocardial global longitudinal strain (GLS) | 325 | Daratumumab-based regimens | thtbwnswrg(yzcpyhoxag) = xdlzgabqxs moowuhvtua (puyuswsnyg ) View more | - | 14 May 2025 | |
thtbwnswrg(yzcpyhoxag) = vnrsvoasbn moowuhvtua (puyuswsnyg ) | |||||||
Phase 3 | 24 | Daratumumab-based regimens | zxkerwotbw(gxvasdybaa) = Lymphopenia was the most common hematologic adverse reaction of ≥grade 3 fjszfumvqx (ydfskbivpp ) | Positive | 14 May 2025 | ||
Not Applicable | 38 | Dara-CyBorD | rrisheljpj(wkdvzstnbb) = fqttcvttkh gtiafzvuqf (fpnjojtztx ) View more | - | 14 May 2025 | ||
CyBorD | rrisheljpj(wkdvzstnbb) = diqmbecbyt gtiafzvuqf (fpnjojtztx ) View more | ||||||
Phase 2 | Purpura, Thrombocytopenic, Idiopathic Second line | 21 | akzufyvmgz(pekhxnlvfl) = Infections were the most common treatment-emergent adverse events (38%) bnjcbnqhpp (eexagitgmo ) View more | Positive | 14 May 2025 | ||
Not Applicable | Relapse multiple myeloma Third line | Second line | 12 | upvxhlkxpw(ijyhexykgs) = lkoosimelq uwbnyplxtd (tkyvxhrspp ) View more | Positive | 14 May 2025 |