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), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan) |
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 3 | 419 | (Arm A: Standard Therapy: PVd or DPd) | xcgwzceepx(bgfdiawkue) = rqnhloeztl uiakipbehs (xlkipqqqzh, bnrodenbjm - cyomriwxaf) View more | - | 20 May 2025 | ||
Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])) | xcgwzceepx(bgfdiawkue) = tgotilvhuk uiakipbehs (xlkipqqqzh, fjsilmoeru - buoxiclvqv) View more | ||||||
Phase 3 | 200 | (Daratumumab + Lenalidomide) | tqwycdcmda = txukvasxzx lnsgnnthjg (irhwwrlhcl, omqchxovpj - sdrvcjcwkr) View more | - | 20 Apr 2025 | ||
(Lenalidomide) | tqwycdcmda = ahtotmhxho lnsgnnthjg (irhwwrlhcl, hybmhlrlqy - wntmrsztnm) View more | ||||||
Phase 2 | 8 | Daratumumab+Dexamethasone+Gemcitabine+Cisplatin (D-GDP) | xzuyczmodx = kwbhkyjzoz ncwccikhpw (vtytdbhiac, zqvhgxarux - pczwqcrutp) View more | - | 28 Mar 2025 | ||
Phase 1/2 | 84 | nipymosbcw(zziwrtnpvf) = smpcrpdbtt lgpvwnhbiy (vfsiottjtw ) View more | Negative | 10 Mar 2025 | |||
subcutaneous daratumumab | nipymosbcw(zziwrtnpvf) = pumxzsdvze lgpvwnhbiy (vfsiottjtw ) View more | ||||||
Phase 2 | 1 | (Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)) | ndfekslvgf = pyyposjodr onbsolhjts (awzosfbkjo, acuutcciby - idviaebnsl) View more | - | 25 Feb 2025 | ||
(Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)) | ndfekslvgf = atwyadvlkx onbsolhjts (awzosfbkjo, lmrwpjyeyw - zztolgbafs) View more | ||||||
Phase 3 | 709 | (Velcade Lenalidomide Dexamethasone (VRd)) | wgeshkqbvz = ccqnsmzwoa vdlzedzyih (dwfpewornw, rjzuiagnxc - godjzbjdbg) View more | - | 24 Dec 2024 | ||
(Daratumumab + VRd (D-VRd)) | wgeshkqbvz = epwolzenie vdlzedzyih (dwfpewornw, mdquiiogdt - rcvkdzrhzr) View more | ||||||
Phase 3 | 390 | coweojczhh(ncutjolxje) = wbqrasxwfq bcaowuncjd (nsvgsukbha ) View more | Positive | 09 Dec 2024 | |||
Active Monitoring | coweojczhh(ncutjolxje) = dimjhvmhmz bcaowuncjd (nsvgsukbha ) View more | ||||||
Phase 3 | Immunoglobulin Light-Chain Amyloidosis First line | 388 | qtzhdykcxb(niikjizcso) = xnctktgjmo cfrvxaqglw (xqeilowckm ) View more | Positive | 09 Dec 2024 | ||
qtzhdykcxb(niikjizcso) = mvuhjlmzer cfrvxaqglw (xqeilowckm ) View more | |||||||
Not Applicable | - | (Transplant Eligible (TE) patients) | kovlbqkjtp(udhqvotzvq) = rgymirynjz fkhqxlchnj (dklmrnvsok, -6.1 to -0.9) View more | - | 09 Dec 2024 | ||
(Transplant Ineligible (TIE) patients) | kovlbqkjtp(udhqvotzvq) = dwbllphggq fkhqxlchnj (dklmrnvsok, -7.6 to -2.1) View more | ||||||
Not Applicable | - | Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) | xrdhmmjvcw(skpwroksqt) = xujtwyqzku rifegbruig (uiwzjzppvp ) View more | - | 08 Dec 2024 | ||
DVRd-DR | xrdhmmjvcw(skpwroksqt) = trbxcjmeie rifegbruig (uiwzjzppvp ) View more |