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Idecabtagene vicleucel

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therapies; 88% had received four or more prior lines of therapies. Efficacy was evaluated in 100 people who received idecabtagene vicleucel in the dose range of 300 to 460 ×10 CAR-positive T cells. Overall, 72% of people partially or completely responded to the treatment. Of those studied, 28% of people showed complete response—or disappearance of all signs of multiple myeloma—to idecabtagene vicleucel, and 65% of this group remained in complete response to the treatment for at least twelve months.
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Multiple myeloma is an uncommon type of blood cancer in which abnormal plasma cells build up in the bone marrow and form tumors in many bones of the body. This disease keeps the bone marrow from making enough healthy blood cells, which can result in low blood counts. Myeloma can also damage the bones
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The safety and efficacy of idecabtagene vicleucel were evaluated in a multicenter study of 127 people with relapsed (myeloma that returns after completion of treatment) and refractory (myeloma that does not respond to treatment) multiple myeloma who received at least three prior lines of antimyeloma
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therapy. Each dose is customized using a patient's own T-cells, which are a type of white blood cell, that are collected and genetically modified to include a new gene that facilitates targeting and killing myeloma cells, and infused back into the patient.
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and the kidneys and weaken the immune system. The exact cause of multiple myeloma is unknown. According to the National Cancer Institute, myeloma accounted for approximately 1.8% (32,000) of all new cancer cases in the United States in 2020.
809: 717: 750:"U.S. Food and Drug Administration Approves Bristol Myers Squibb's and bluebird bio's Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma" 486: 159: 810:"FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies" 1052: 2794: 705: 71: 1752: 348:
for the treatment of adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a
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Idecabtagene vicleucel was approved for medical use in the United States in March 2021. It is the first cell-based gene therapy approved by the US
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World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81".
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for "Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa)" at
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Munshi NC, Anderson LD, Shah N, Madduri D, Berdeja J, Lonial S, et al. (February 2021).
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In April 2024, the FDA label boxed warning was expanded to include T cell malignancies.
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Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, et al. (May 2019).
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This article incorporates text from this source, which is in the
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This article incorporates text from this source, which is in the
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This article incorporates text from this source, which is in the
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for cytokine release syndrome (CRS), neurologic toxicity,
399:(FDA) granted the application for idecabtagene vicleucel 198: 310:, musculoskeletal pain, and a weakened immune system ( 2762: 407:
designations. The FDA granted approval of Abecma to
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medicinal products 577:from the original on 9 December 2023 171: 1322:ribonucleotide reductase inhibitors 790:from the original on 1 October 2023 623:from the original on 26 August 2021 275: 1488:Ribonucleotide reductase inhibitor 1444:Ribonucleotide reductase inhibitor 1003:: CS1 maint: overridden setting ( 944:: CS1 maint: overridden setting ( 824:from the original on 19 April 2024 760:from the original on 29 March 2021 720:from the original on 28 March 2021 370:hemophagocytic lymphohistiocytosis 14: 1247:Dihydrofolate reductase inhibitor 653:from the original on 5 March 2023 430:international nonproprietary name 2772: 834: 730: 716:(Press release). 27 March 2021. 587: 489:from the original on 29 May 2022 1384:Thymidylate synthase inhibitor 1274:Thymidylate synthase inhibitor 428:Idecabtagene vicleucel is the 374:macrophage activation syndrome 1: 1304:Adenosine deaminase inhibitor 1145:Block microtubule disassembly 816:Food and Drug Administration 712:Food and Drug Administration 643:"Abecma Product information" 569:Food and Drug Administration 397:Food and Drug Administration 334:Food and Drug Administration 317:Idecabtagene vicleucel is a 291:, sold under the brand name 2831: 768:– via Business Wire. 344:Idecabtagene vicleucel is 2723: 2604:Omacetaxine mepesuccinate 2484:Ciltacabtagene autoleucel 2474:Brexucabtagene autoleucel 615:European Medicines Agency 376:(HLH/MAS), and prolonged 319:B-cell maturation antigen 304:cytokine release syndrome 2656:Talimogene laherparepvec 2589:Nadofaragene firadenovec 2559:Lisocabtagene maraleucel 1508:Topoisomerase inhibitors 1427:DNA polymerase inhibitor 2805:Approved gene therapies 2459:Axicabtagene ciloleucel 1063:chemotherapeutic agents 16:Gene therapy medication 2641:Sitimagene ceradenovec 2539:Idecabtagene vicleucel 2104:Methyl aminolevulinate 1018:Clinical trial number 289:Idecabtagene vicleucel 123:Idecabtagene vicleucel 23:Idecabtagene vicleucel 2115:Porphyrin derivatives 1811:Melphalan flufenamide 1458:Hypomethylating agent 1067:antineoplastic agents 972:10.1056/NEJMoa1817226 905:10.1056/NEJMoa2024850 312:hypogammaglobulinemia 2444:Asparagine depleters 2373:Receptor antagonists 2287:+abiraterone acetate 855:WHO Drug Information 754:Bristol Myers Squibb 413:Bristol-Myers Squibb 401:breakthrough therapy 350:proteasome inhibitor 2494:Denileukin diftitox 2394:Retinoid X receptor 2094:Aminolevulinic acid 1916:Triethylenemelamine 1748:Crosslinking of DNA 1479:Deoxyribonucleotide 1418:+gimeracil/oteracil 485:. 23 October 2014. 419:Society and culture 409:Celgene Corporation 306:(CRS), infections, 25: 2810:CAR T-cell therapy 2750:Never to phase III 1552:Etirinotecan pegol 1026:ClinicalTrials.gov 786:. 19 August 2021. 2800:Cancer treatments 2760: 2759: 2719: 2718: 2676:Tigilanol tiglate 2153:Enzyme inhibitors 2076: 2075: 2072: 2071: 1772:Nitrogen mustards 1742: 1741: 1502: 1501: 1204: 1203: 820:. 18 April 2024. 756:. 26 March 2021. 752:(Press release). 573:. 27 March 2021. 286: 285: 233: 218: 201: 115: 2822: 2777: 2776: 2775: 2768: 2681:Tisagenlecleucel 2438:Arsenic trioxide 2149: 2082:Photosensitizers 1873:Alkyl sulfonates 1787:Cyclophosphamide 1759: 1698:Anthracenediones 1519: 1493:Hydroxycarbamide 1234: 1217: 1095: 1055: 1048: 1041: 1032: 1008: 1002: 994: 984: 974: 949: 943: 935: 917: 907: 873: 872: 870: 850: 844: 838: 837: 833: 831: 829: 806: 800: 799: 797: 795: 776: 770: 769: 767: 765: 746: 740: 734: 733: 729: 727: 725: 702: 663: 662: 660: 658: 639: 633: 632: 630: 628: 619:. 23 June 2021. 606: 597: 591: 590: 586: 584: 582: 559: 530: 529: 527: 525: 510: 499: 498: 496: 494: 475: 469: 468: 466: 464: 454:nctr-crs.fda.gov 446: 297:multiple myeloma 279: 259: 231: 228: 223: 216: 213: 209: 200: 197: 175: 125: 114: 111: 98: 84: 26: 24: 2830: 2829: 2825: 2824: 2823: 2821: 2820: 2819: 2785: 2784: 2783: 2773: 2771: 2763: 2761: 2756: 2755: 2740:Clinical trials 2715: 2421:Other/ungrouped 2416: 2367: 2140: 2120:Porfimer sodium 2068: 2030: 1963: 1920: 1750: 1738: 1622: 1592: 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1161: 1159: 1155: 1154: 1150: 1149: 1147: 1143: 1136: 1133: 1131: 1128: 1126: 1123: 1121: 1118: 1116: 1112: 1111: 1107: 1106: 1104: 1101: 1096: 1093: 1090: 1085: 1081: 1077: 1072: 1068: 1064: 1056: 1051: 1049: 1044: 1042: 1037: 1036: 1033: 1027: 1023: 1022: 1017: 1016: 1012: 1006: 1000: 992: 988: 983: 978: 973: 968: 964: 960: 956: 951: 947: 941: 933: 929: 925: 921: 916: 911: 906: 901: 898:(8): 705–16. 897: 893: 889: 884: 883: 879: 869: 864: 860: 856: 849: 846: 842: 841:public domain 823: 819: 817: 811: 805: 802: 789: 785: 781: 775: 772: 759: 755: 751: 745: 742: 738: 737:public domain 719: 715: 713: 707: 701: 699: 697: 695: 693: 691: 689: 687: 685: 683: 681: 679: 677: 675: 673: 671: 669: 665: 652: 648: 644: 638: 635: 622: 618: 616: 611: 610:"Abecma EPAR" 605: 603: 599: 595: 594:public domain 576: 572: 570: 564: 558: 556: 554: 552: 550: 548: 546: 544: 542: 540: 538: 536: 532: 519: 515: 509: 507: 505: 501: 488: 484: 483:Health Canada 480: 474: 471: 459: 455: 451: 445: 442: 435: 433: 431: 423: 418: 416: 414: 410: 406: 402: 398: 393: 386: 384: 381: 379: 375: 371: 367: 366:boxed warning 359: 357: 353: 351: 347: 339: 337: 335: 330: 327: 324: 320: 315: 313: 309: 305: 300: 298: 294: 290: 278: 274: 273: 271: 269: 265: 258: 254: 253: 251: 249: 245: 240: 234: Rx-only 227: 224: 212: 205: 196: 195: 193: 191: 187: 182: 174: 169: 166: 165: 163: 161: 157: 154: 151: 149: 145: 142: 139: 137: 131: 124: 119: 110: 109: 107: 105: 101: 97: 93: 91: 87: 83: 79: 77: 73: 69: 65: 61: 57: 55: 51: 48:Clinical data 46: 43: 40: 38: 34: 31: 27: 19: 2815:Orphan drugs 2661:Tazemetostat 2625:Alitretinoin 2618: 2538: 2529:Estramustine 2509:Elsamitrucin 2499:Eflornithine 2453:Pegaspargase 2449:Asparaginase 2442: 2411:Testolactone 2404: 2392: 2380: 2334: 2319:Panobinostat 2302: 2272: 2260: 2248: 2236: 2207: 2172: 2160: 2113: 2109:Padeliporfin 2048:Dactinomycin 2044:Streptomyces 2025:Temozolomide 2020:Mitozolomide 2008: 1999:Mitobronitol 1988:Procarbazine 1981: 1969:Nonclassical 1894: 1871: 1865:Streptozocin 1830:Nitrosoureas 1828: 1802:Chlorambucil 1796:Trofosfamide 1782:Chlormethine 1777:Bendamustine 1770: 1708:Mitoxantrone 1703:Losoxantrone 1696: 1656:Daunorubicin 1639: 1605: 1542:Camptothecin 1530: 1486: 1456: 1442: 1425: 1409:Fluorouracil 1389:Capecitabine 1382: 1352: 1316: 1302: 1272: 1267:Pralatrexate 1257:Methotrexate 1245: 1188: 1151: 1108: 1019: 999:cite journal 962: 959:N Engl J Med 958: 940:cite journal 915:11585/865225 895: 892:N Engl J Med 891: 868:10665/330896 858: 854: 848: 826:. Retrieved 813: 804: 792:. Retrieved 783: 774: 762:. Retrieved 744: 722:. Retrieved 709: 655:. Retrieved 646: 637: 625:. Retrieved 613: 579:. Retrieved 566: 524:20 September 522:. Retrieved 517: 491:. Retrieved 482: 473: 461:. Retrieved 453: 444: 427: 394: 390: 382: 363: 354: 343: 340:Medical uses 331: 316: 301: 292: 288: 287: 190:Legal status 184:Legal status 104:License data 30:Gene therapy 18: 2736:from market 2706:Vorasidenib 2686:Trabectedin 2671:Tiazofurine 2666:Tebentafusp 2651:Tagraxofusp 2609:Plitidepsin 2579:Mitoguazone 2519:Epacadostat 2489:Demecolcine 2433:Aflibercept 2406:Sex steroid 2279:Fuzuloparib 2220:Carfilzomib 2192:Palbociclib 2182:Abemaciclib 2135:Verteporfin 2099:Efaproxiral 2015:Dacarbazine 1977:Altretamine 1959:Satraplatin 1954:Oxaliplatin 1934:Carboplatin 1911:Triaziquone 1882:Mannosulfan 1860:Ranimustine 1840:Fotemustine 1681:Pirarubicin 1666:Doxorubicin 1660:+cytarabine 1646:Aclarubicin 1607:Podophyllum 1532:Camptotheca 1463:Azacitidine 1449:Gemcitabine 1404:Floxuridine 1337:Fludarabine 1332:Clofarabine 1318:Halogenated 1309:Pentostatin 1284:Raltitrexed 1252:Aminopterin 1195:Ixabepilone 1190:Epothilones 1158:Cabazitaxel 1135:Vinorelbine 1120:Vincristine 1115:Vinblastine 1100:microtubule 1021:NCT03361748 861:(1): 78-9. 405:orphan drug 242:Identifiers 225:Rx-only< 141:Intravenous 90:MedlinePlus 63:Other names 54:Trade names 37:Target gene 2789:Categories 2701:Verdinexor 2696:Venetoclax 2599:Oblimersen 2594:Navitoclax 2569:Lucanthone 2564:Lonidamine 2554:Lifileucel 2549:Ivosidenib 2544:Imetelstat 2514:Enasidenib 2504:Elesclomol 2469:Bexarotene 2464:Belzutifan 2399:Bexarotene 2387:Atrasentan 2362:Umbralisib 2357:Idelalisib 2347:Copanlisib 2329:Vorinostat 2324:Romidepsin 2314:Entinostat 2309:Belinostat 2267:Masoprocol 2255:Tiazofurin 2243:Anagrelide 2215:Bortezomib 2202:Seliciclib 2197:Ribociclib 2177:inhibitors 2167:Tipifarnib 2130:Temoporfin 2125:Talaporfin 2063:Plicamycin 2058:Mitomycins 2004:Pipobroman 1983:Hydrazines 1949:Nedaplatin 1901:Carboquone 1896:Aziridines 1887:Treosulfan 1835:Carmustine 1822:Uramustine 1791:Ifosfamide 1763:Alkylating 1724:Bisantrene 1713:Pixantrone 1686:Valrubicin 1676:Idarubicin 1671:Epirubicin 1617:Teniposide 1572:Lurtotecan 1567:Irinotecan 1468:Decitabine 1432:Cytarabine 1375:Pyrimidine 1364:Tioguanine 1354:Thiopurine 1343:Nelarabine 1327:Cladribine 1279:Pemetrexed 1262:Pemetrexed 1238:Folic acid 1178:Paclitaxel 1130:Vinflunine 463:22 October 436:References 323:autologous 257:8PX1X7UG4D 210:Schedule D 148:Drug class 2746:Phase III 2734:Withdrawn 2711:Vosaroxin 2691:Veliparib 2646:Sotorasib 2636:Selinexor 2630:Tretinoin 2620:Retinoids 2534:Glasdegib 2479:Celecoxib 2428:Adagrasib 2352:Duvelisib 2342:Alpelisib 2297:Rucaparib 2284:Niraparib 2225:Oprozomib 2187:Alvocidib 2053:Bleomycin 2010:Triazenes 1994:Etoglucid 1939:Cisplatin 1855:Nimustine 1849:Semustine 1845:Lomustine 1807:Melphalan 1734:Menogaril 1729:Crisnatol 1719:Amsacrine 1691:Zorubicin 1651:Amrubicin 1612:Etoposide 1587:Topotecan 1582:Silatecan 1577:Rubitecan 1562:Gimatecan 1547:Cositecan 1537:Belotecan 1213:inhibitor 1183:Tesetaxel 1173:Ortataxel 1168:Larotaxel 1163:Docetaxel 1125:Vindesine 932:232048693 794:1 October 627:26 August 415:Company. 378:cytopenia 346:indicated 134:Routes of 82:Monograph 76:Drugs.com 2779:Medicine 2584:Mitotane 2524:Eribulin 2292:Olaparib 2230:Ixazomib 1906:Thiotepa 1878:Busulfan 1557:Exatecan 1394:Carmofur 1102:assembly 1065: / 991:31042825 924:33626253 828:19 April 822:Archived 788:Archived 780:"Abecma" 764:29 March 758:Archived 724:29 March 718:Archived 651:Archived 621:Archived 581:29 March 575:Archived 563:"Abecma" 518:DailyMed 487:Archived 160:ATC code 118:DailyMed 42:TNFRSF17 1513:S phase 1414:Tegafur 1228:S phase 1153:Taxanes 1089:M phase 982:8202968 657:3 March 432:(INN). 395:The US 387:History 308:fatigue 222:WARNING 206: / 202:: 176:) 170: ( 168:L01XL07 120::  96:a621024 2765:Portal 2729:WHO-EM 2338:(Pi3K) 1295:Purine 1098:Block 989:  979:  930:  922:  493:29 May 293:Abecma 277:D11556 219: 208:  204:℞-only 116:  58:Abecma 2250:IMPDI 2145:Other 928:S2CID 818:(FDA) 814:U.S. 714:(FDA) 710:U.S. 617:(EMA) 571:(FDA) 567:U.S. 424:Names 2336:PIKI 2304:HDAC 1753:CCNS 1005:link 987:PMID 946:link 920:PMID 830:2024 796:2023 766:2021 726:2021 659:2023 629:2021 583:2021 526:2024 495:2022 465:2023 411:, a 403:and 268:KEGG 248:UNII 72:AHFS 2382:ERA 2238:PhI 2209:PrI 2174:CDK 2086:PDT 1084:MIs 1080:SPs 1071:L01 977:PMC 967:doi 963:380 910:hdl 900:doi 896:384 863:hdl 458:FDA 314:). 173:WHO 2791:: 2742:: 2262:LI 2162:FI 1628:II 1598:II 1420:)) 1001:}} 997:{{ 985:. 975:. 961:. 957:. 942:}} 938:{{ 926:. 918:. 908:. 894:. 890:. 859:33 857:. 812:. 782:. 708:. 667:^ 649:. 645:. 612:. 601:^ 565:. 534:^ 516:. 503:^ 481:. 456:. 452:. 299:. 230:EU 215:US 199:CA 113:US 2767:: 2632:) 2623:( 2455:) 2451:/ 2447:( 2413:) 2409:( 2401:) 2397:( 2389:) 2385:( 2364:) 2340:( 2331:) 2307:( 2299:) 2277:( 2269:) 2265:( 2257:) 2253:( 2245:) 2241:( 2204:) 2180:( 2169:) 2165:( 2137:) 2118:( 2084:/ 2065:) 2046:( 2027:) 2013:( 1990:) 1986:( 1898:: 1889:) 1880:( 1875:: 1851:) 1847:( 1832:: 1813:) 1809:( 1798:) 1789:( 1774:: 1755:) 1751:( 1715:) 1701:( 1693:) 1662:) 1658:( 1644:( 1630:+ 1619:) 1610:( 1589:) 1535:( 1523:I 1515:) 1511:( 1495:) 1491:( 1470:) 1461:( 1451:) 1447:( 1437:) 1430:( 1416:( 1387:( 1366:) 1357:( 1339:) 1325:( 1320:/ 1311:) 1307:( 1286:) 1277:( 1269:) 1250:( 1230:) 1226:( 1197:) 1193:( 1185:) 1156:( 1137:) 1113:( 1091:) 1087:( 1082:/ 1073:) 1069:( 1054:e 1047:t 1040:v 1007:) 993:. 969:: 948:) 934:. 912:: 902:: 871:. 865:: 843:. 832:. 798:. 739:. 728:. 661:. 631:. 596:. 585:. 528:. 497:. 467:. 372:/ 232:: 217:: 74:/

Index

Gene therapy
Target gene
TNFRSF17
Trade names
AHFS
Drugs.com
Monograph
MedlinePlus
a621024
License data
DailyMed
Idecabtagene vicleucel
Routes of
administration

Intravenous
Drug class
Antineoplastic
ATC code
L01XL07
WHO
Legal status
℞-only
WARNING
UNII
8PX1X7UG4D
KEGG
D11556
multiple myeloma
cytokine release syndrome
fatigue
hypogammaglobulinemia

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