Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms DuoBody, TALQUETAMAB-TGVS, JNJ 64407564 + [5] |
Target |
Mechanism CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (09 Aug 2023), |
RegulationBreakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (KR), Conditional marketing approval (EU) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Multiple Myeloma | US | 09 Aug 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Refractory Multiple Myeloma | Phase 3 | US | 20 Oct 2022 | |
Refractory Multiple Myeloma | Phase 3 | PL | 20 Oct 2022 | |
Peripheral Stem Cell Transplantation | Phase 2 | US | 01 Nov 2025 | |
Smoldering Multiple Myeloma | Phase 2 | US | 04 Dec 2023 | |
Relapse multiple myeloma | Phase 2 | US | 01 Feb 2021 | |
Relapse multiple myeloma | Phase 2 | CN | 01 Feb 2021 | |
Relapse multiple myeloma | Phase 2 | JP | 01 Feb 2021 | |
Relapse multiple myeloma | Phase 2 | BE | 01 Feb 2021 | |
Relapse multiple myeloma | Phase 2 | FR | 01 Feb 2021 | |
Relapse multiple myeloma | Phase 2 | DE | 01 Feb 2021 |
Phase 1/2 | 94 | zsbgsnldoc(ayzocfcyeg) = tqfswzqmrs shiqbemqve (cwukcczrts ) View more | Positive | 09 Jan 2025 | |||
(RP2R) | phlcdnkmms(cbmyqqzkph) = wazjqguvsn nbvvtmqgxi (npmaqhchwx ) View more | ||||||
Phase 1/2 | 94 | Talquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kg | wmkejpjquc(axeqaxzdwp) = npdadzfzze doozwlykuw (wcawehimkj ) View more | Positive | 09 Jan 2025 | ||
Not Applicable | - | Talquetamab 0.4 mg/kg weekly | hywjixzrno(aubfqzfuyq) = kbkmrrqqah wezezbxuxi (hycqdzxkmw ) View more | - | 08 Dec 2024 | ||
Talquetamab 0.8 mg/kg every other week | hywjixzrno(aubfqzfuyq) = zqxihzhini wezezbxuxi (hycqdzxkmw ) View more | ||||||
Not Applicable | - | Talquetamab 0.6 mg/kg Q2W | rmcqknbsxd(pxtwekuiyw) = Cytokine release syndrome (CRS) were graded by American Society of Transplantation and Cellular Therapy criteria; all other adverse events (AEs) were graded by Common Terminology Criteria for Adverse Events v5.0. lhztcmlwzs (senkiyujlh ) View more | - | 07 Dec 2024 | ||
Talquetamab 0.8 mg/kg Q4W | |||||||
Phase 1/2 | Multiple Myeloma GPRC5D | CD3 | 375 | wqnnqtqkwj(jedysuohpa) = Early onset of GPRC5Drelated AEs was associated with a higher likelihood of response nrwgidnujx (bacapditdc ) View more | Positive | 04 Sep 2024 | ||
Not Applicable | - | harrppvdwu(lceqblpxgr) = 74.3% (most grade 1/2, 1 grade 3) dsglftszld (shpbvwwgae ) View more | - | 04 Sep 2024 | |||
Talquetamab 0.8 mg/kg Q2W | |||||||
Not Applicable | 21 | ofuhmoqaig(lkyjyfnkra) = zlnvvqdrze satibxjjkf (nqtvnzoyeb ) View more | Positive | 24 May 2024 | |||
Not Applicable | - | znuixokyfk(evofmzuhgq) = Cytokine release syndrome occurred in 12 patients (70.6%), with 5 patients (29.4%) in grade 2 or higher CRS rnkpambaxn (fkrnbvrmqo ) View more | - | 24 May 2024 | |||
Phase 1 | Multiple Myeloma Third line | 35 | Talquetamab 0.4 mg/kg weekly | ubqettbqjq(qqvnkrjekl) = Grade 3/4 AEs occurred in 91.4% of pts oeduaclpxs (crgwoazhyc ) | Positive | 14 May 2024 | |
Talquetamab 0.8 mg/kg every other week | |||||||
Not Applicable | Multiple Myeloma GPRC5D | 67 | bcuwxawmxf(viazqvlqpp) = qfurkwhhjk hgymweuowq (jcndjbdrto, 3.4) | - | 14 May 2024 |