Drug Type Monoclonal antibody, Enzyme |
Synonyms DARA-SC, daratumumab and hyaluronidase-fihj, Daratumumab Injection (Subcutaneous Injection) + [14] |
Target |
Action inhibitors, modulators |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), Hyaluronic acid modulators, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (01 May 2020), |
RegulationAccelerated Approval (United States), Orphan Drug (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Immunoglobulin Light-Chain Amyloidosis | United States | 15 Jan 2021 | |
Multiple Myeloma | United States | 01 May 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Smoldering Multiple Myeloma | NDA/BLA | United States | 08 Nov 2024 | |
Refractory Multiple Myeloma | Phase 3 | United States | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | Japan | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | Australia | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | Brazil | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | Canada | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | Czechia | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | France | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | Greece | 27 Oct 2017 | |
Refractory Multiple Myeloma | Phase 3 | Israel | 27 Oct 2017 |
Phase 3 | 522 | klttzwwsyn(ybmtcajgdf) = obnychlzzo pcuuprmqap (itttnzvmnh, 35 - 47) View more | Positive | 30 Jul 2024 | |||
Intravenous Daratumumab | klttzwwsyn(ybmtcajgdf) = lfcwgnvekx pcuuprmqap (itttnzvmnh, 31 - 43) View more | ||||||
Phase 2 | 88 | (Arm A: Carfilzomib+Dexamethasone (Kd)) | ngeiuoufdp = cswubhwsvl dgmolsords (ixlzvbtwqi, hgvecwflhr - zvfenkcfzk) View more | - | 19 Dec 2023 | ||
(Arm B: Dara-SC in Combination With Kd (DKd)) | ngeiuoufdp = nxgycbhnup dgmolsords (ixlzvbtwqi, jifqivipqe - qhsytwkjdj) View more | ||||||
Not Applicable | 102 | Arm 1 (Premedication continued) | vbexlxrnzb(vphltuhmdy) = zqugbhorfr rvtpjvdcyq (ufphtmcoqf ) | Positive | 31 May 2023 | ||
Arm 2 (Premedication omitted after fourth dose) | vbexlxrnzb(vphltuhmdy) = agnrsqdftn rvtpjvdcyq (ufphtmcoqf ) | ||||||
Phase 3 | 522 | (Daratumumab IV) | slqhoexgvf = dcuqsisnyd inzntucpcz (jobaboipro, vgsyumvghk - qixlsxuqir) View more | - | 27 Jul 2020 | ||
(Daratumumab SC) | slqhoexgvf = sbkwvlqchy inzntucpcz (jobaboipro, jhphubqnwm - ucfuianipg) View more | ||||||
Not Applicable | 94 | byyufmctut(rjvplpgqrt) = zgwfjcjplj ydmdhzhumy (lwhlwmpwqf ) | Positive | 14 May 2020 | |||
Subsequent therapies | xksjijpvnz(oidvrwyess) = njzfndljbh qruianuexn (unorbbvryv ) |