JANUARY 27, 2023-Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), kambani yepasi rose yebiotechnology inogadzira, inogadzira uye inotengeserana novel therapies kurapa zvirwere zvinouraya, yakazivisa nhasi kuti CARTITUDE-4, Phase 3 yekuongorora kuongorora CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) yekurapa varwere vakura vane kudzokazve uye lenalidomide-refractory multiple myeloma, yakasangana nemagumo ayo ekutanga ekuratidza kuvandudzwa kwenhamba mukurarama-kusina kupona (PFS) kana ichienzaniswa nekurapa kwakajairwa paongororo yekutanga yakatsanangurwa yenguva pfupi yechidzidzo. . Ongororo iyi yanga isina kuvharwa zvichitevera kurudziro yekomiti yakazvimirira inoona nezve data.
The CARTITUDE-4 (NCT04181827) chidzidzo chekutanga chepasi rose, randomized, open-label Phase 3 chidzidzo chekuongorora kushanda uye kuchengeteka kweCAR-T therapy maringe nepomalidomide, bortezomib uye dexamethasone (PVd) kana daratumumab, poxamalidosomide uye DP muvarwere vakura vane kudzokazve uye lenalidomide-refractory multiple myeloma vakagamuchira imwe kusvika kumatatu mitsara yekurapa.
Mhedziso yekutanga yechidzidzo iPFS. Sekondari magumo anosanganisira kuchengetedzeka, kupona kwese (OS), kushoma residual chirwere (MRD) yakashata mwero uye yakazara mhinduro mwero (ORR). Varwere vacharamba vachiteverwa kumagumo epuraimari uye echipiri sechikamu cheCARTITUDE-4 kudzidza.
“Autologous CAR-T cell therapy represents a major breakthrough in cancer treatment, and topline results from CARTITUDE-4 support our continuous efforts to bring this treatment option to patients with akawanda myeloma in various stages of disease progression,” Lida Pacaud, M.D., Vice President of Clinical Development and Medical Affairs at Legend Biotech, said.
Mibairo kubva kuchidzidzo cheCARTITUDE-4 ichaendeswa kumusangano wekurapa unouya uye ichatsigira nhaurirano nevakuru vehutano nezvezvingangove zvinotumirwa.
CARVYKTI® ZVIRATIDZO UYE MASHANDISI
CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA) -inotungamirirwa genetically modified autologous T cell immunotherapy inoratidzirwa kurapwa kwevarwere vakuru vane kudzokazve kana kuti refractory multiple myeloma, mushure memitsara mina kana kupfuura yapfuura yerapi, kusanganisira proteasome inhibitor, immunomodulatory agent, uye anti-CD38 monoclonal antibody.
YAMBIRO NEZVOZVO
CYTOKINE RELEASE SYNDROME (CRS) kusanganisira kuuraya kana kutyisidzira upenyu, kwakaitika zvichitevera kurapwa neCARVYKTI® mu95% (92/97) yevarwere vanogamuchira ciltacabtagene autoleucel. Giredhi 3 kana yepamusoro CRS (2019 ASTCT giredhi) yakaitika mu5% (5/97) yevarwere, neGiredhi 5 CRS yakashumwa mune 1 murwere. Nguva yepakati pekutanga kweCRS yaive mazuva manomwe (renji: 7-1 mazuva). Zviratidzo zvakajairika zveCRS zvaisanganisira pyrexia (12%), hypotension (100%), yakawedzera aspartate aminotransferase (AST) (43%), chills (22%), yakawedzera alanine aminotransferase (ALT) (15%) uye sinus tachycardia ( 14%). Giredhi 11 kana zviitiko zvepamusoro zvakabatana neCRS zvaisanganisira kuwedzera AST uye ALT, hyperbilirubinemia, hypotension, pyrexia, hypoxia, kutadza kufema, kukuvara kwakanyanya kweitsvo, kuparadzira intravascular coagulation, HLH/MAS, angina pectoris, supraventricular uye ventricular tachycardia, malaise, myalgias, yakawedzera. C-reactive protein, ferritin, ropa alkaline phosphatase uye gamma-glutamyl transferase.
Ziva CRS zvichienderana nekiriniki mharidzo. Ongorora uye kurapa zvimwe zvikonzero zvefivha, hypoxia, uye hypotension. CRS inonzi yakabatana nezvakawanikwa zveHLH/MAS, uye physiology yemasyndromes inogona kupindirana. HLH/MAS idambudziko rinogona kuisa hupenyu panjodzi. Muvarwere vane zviratidzo zvinofambira mberi zveCRS kana refractory CRS kunyangwe kurapwa, ongorora humbowo hweHLH/MAS.
Makumi matanhatu nevapfumbamwe ve97 (71%) varwere vakagamuchira tocilizumab uye/kana corticosteroid yeCRS mushure mekuisirwa ciltacabtagene autoleucel. Varwere makumi mana nevana (45%) vakagamuchira chete tocilizumab, avo 33 (34%) vakagamuchira chirwere chimwe chete uye 11 (11%) vakagamuchira inopfuura imwe yero; Varwere ve24 (25%) vakagamuchira tocilizumab uye corticosteroid, uye murwere mumwe (1%) akagamuchira corticosteroids chete. Ita shuwa kuti mashoma emadhora maviri etocilizumab anowanikwa isati yaiswa CARVYKTI®.
Tarisa varwere zuva nezuva kwemazuva gumi uchitevera CARVYKTI® infusion paREMS-yakasimbiswa nzvimbo yehutano yezviratidzo nezviratidzo zveCRS. Tarisa varwere kune zviratidzo kana zviratidzo zveCRS kweinenge mavhiki mana mushure mekunyudzwa. Pachiratidzo chekutanga cheCRS, pakarepo tanga kurapwa nerutsigiro rwekutarisira, tocilizumab, kana tocilizumab uye corticosteroids.
Raira varwere kuti vatsvage kurapwa nekukurumidza kana zviratidzo kana zviratidzo zveCRS zvikaitika chero nguva.
NEUROLOGIC TOXICITIES, iyo inogona kunge yakaoma, inouraya kana kuuraya, yakaitika mushure mekurapa neCARVYKTI®. Neurologic toxicities yaisanganisira ICANS, neurologic toxicity ine zviratidzo uye zviratidzo zveparkinsonism, Guillain-Barré Syndrome, peripheral neuropathies, uye cranial nerve palsies. Rayirira varwere nezvezviratidzo uye zviratidzo zveiyi neurologic toxicity, uye pane kunonoka hunhu hwekutanga kwehumwe hwehupfu. Raira varwere kuti vatsvage kurapwa nekukurumidza kuti vawedzere kuongororwa uye manejimendi kana zviratidzo kana zviratidzo zveimwe yeiyi neurologic toxicity zvikaitika chero nguva.
Kakawanda, imwe kana kupfuura subtypes yeurologic toxicity inotsanangurwa pazasi yakaitika zvichitevera ciltacabtagene autoleucel mu26% (25/97) yevarwere, iyo 11% (11/97) yevarwere vakawana Giredhi 3 kana zviitiko zvepamusoro. Aya ma subtypes eeurologic toxicities akaonekwawo muzvidzidzo zviviri zvirikuenderera mberi.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Varwere vanogona kusangana nerufu kana hupenyu hunotyisidzira ICANS mushure mekurapwa neCARVYKTI.®, kusanganisira isati yatanga CRS, panguva imwe chete neCRS, mushure mekugadziriswa kweCRS, kana kusavapo kweCRS. ICANS yakaitika mu23% (22/97) yevarwere vanowana ciltacabtagene autoleucel kusanganisira Giredhi 3 kana 4 zviitiko mu3% (3/97) uye Giredhi 5 (inouraya) zviitiko mu2% (2/97). Iyo yepakati nguva yekutanga kweICANS yaive mazuva masere (renji 8-1 mazuva). Vese varwere makumi maviri nevaviri vane ICANS vaive neCRS. Kunyanya kuratidzwa (≥28%) kuratidzwa kweICANS kwaisanganisira encephalopathy (22%), aphasia (5%) uye musoro (23%).
Tarisa varwere zuva nezuva kwemazuva gumi uchitevera CARVYKTI® infusion paREMS-yakasimbiswa nzvimbo yehutano yezviratidzo nezviratidzo zveICANS. Rega zvimwe zvikonzero zveICANS zviratidzo. Tarisa varwere kune zviratidzo kana zviratidzo zveICANS kweinenge mavhiki mana mushure mekuisirwa uye kurapa nekukurumidza. Neurologic toxicity inofanira kutarisirwa nerutsigiro rwekuchengetedza uye / kana corticosteroids sezvinodiwa.
Parkinsonism: Pavarwere makumi maviri nevashanu vari muCARTITUDE-25 kudzidza vachiona chero neurotoxicity, varwere vashanu vechirume vaive neurological toxicity ine akati wandei zviratidzo uye zviratidzo zveparkinsonism, zvakasiyana neimmune effector cell-associated neurotoxicity syndrome (ICANS). Neurologic toxicity ne parkinsonism yakashumwa mune mamwe maedzo anoenderera mberi e ciltacabtagene autoleucel. Varwere vaive nezviratidzo zveparkinsonian uye zvisiri zveparkinsonian zvinosanganisira kudedera, bradykinesia, kufamba kusingaite, stereotypy, kurasikirwa nekufamba kwechinyakare, kumeso kwakavharika, kusafarira, flat impact, kuneta, kuoma, psychomotor retardation, micrographia, dysfusionia, apraxia, sothargy , kurasikirwa nekuziva, kunonoka kufungidzira, hyperreflexia, kurasikirwa nendangariro, kunetseka kumedza, kusaita ura, kupunzika, kumira kwakakotama, kufamba-famba, kushaya simba kwetsandanyama uye kupera, kusashanda zvakanaka kwemotokari, kurasikirwa nemotokari uye kunzwa, akinetic mutism, uye zviratidzo zvekubuda kwelobe pamberi. Iyo yepakati pekutanga kwe parkinsonism muvarwere ve1 muCARTITUDE-5 yaive mazuva makumi mana nematatu (rengere 1-43) kubva pakuiswa kwe ciltacabtagene autoleucel.
Tarisa varwere kune zviratidzo uye zviratidzo zve parkinsonism zvinogona kunonoka kutanga uye kutungamirirwa nematanho ekuchengeta anotsigira. Pane ruzivo rushoma rwekushanda nemishonga inoshandiswa kurapa chirwere cheParkinson, pakuvandudza kana kugadziriswa kwezviratidzo zve parkinsonism zvinotevera CARVYKTI.® kurapwa.
Guillain-Barré Syndrome: Mhedzisiro inouraya inotevera Guillain-Barré Syndrome (GBS) yakaitika mune imwe ongororo inoenderera ye ciltacabtagene autoleucel kunyangwe kurapwa neintravenous immunoglobulins. Zviratidzo zvinoshumwa zvinosanganisira izvo zvinoenderana neMiller-Fisher musiyano weGBS, encephalopathy, kushaya simba kwemota, kuvhiringika kwekutaura uye polyradiculoneuritis.
Monitor yeGBS. Ongorora varwere vanouya neperipheral neuropathy yeGBS. Funga kurapwa kweGBS nematanho ekuchengeta anotsigira uye pamwe chete nemaimmunoglobulins uye plasma exchange, zvichienderana nekuoma kweGBS.
Peripheral Neuropathy: Vatanhatu varwere muCARTITUDE-1 vakagadzira peripheral neuropathy. Aya ma neuropathies anoratidzwa semanzwiro, mota kana sensorimotor neuropathies. Nguva yeMedhia yekutanga kwezviratidzo yaiva mazuva 62 (mazuva 4-136), nguva yepakati yeperipheral neuropathies yaiva mazuva 256 (mazuva 2-465) kusanganisira avo vane chirwere chinoramba chichienderera mberi. Varwere vakawana peripheral neuropathy vakawanawo cranial nerve palsies kana GBS mune mimwe miedzo inoenderera ye ciltacabtagene autoleucel.
Cranial Nerve Palsies: Varwere vatatu (3.1%) vakawana cranial nerve palsies muCARTITUDE-1. Vose varwere vatatu vaiva ne7th cranial nerve palsy; mumwe murwere aive ne5th cranial nerve palsy zvakare. Nguva yeMedhia yekutanga yaive mazuva makumi maviri nematanhatu (mazuva 26-21) achitevera kuiswa kweciltacabtagene autoleucel. Kuitika kwe101rd uye 3th cranial nerve palsy, bilateral 6th cranial nerve palsy, kuwedzera kwecranial nerve palsy mushure mekuvandudzwa, uye kuitika kweperipheral neuropathy kune varwere vane cranial nerve palsy zvakataurwawo mukuedzwa kunoenderera mberi kweciltacabtagene autoleucel. Tarisa varwere kune zviratidzo uye zviratidzo zvecranial nerve palsies. Funga manejimendi ne systemic corticosteroids, zvichienderana nekuoma uye kufambira mberi kwezviratidzo nezviratidzo.
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Inouraya HLH yakaitika mune mumwe murwere (1%), mazuva 99 mushure me ciltacabtagene autoleucel. Chiitiko cheHLH chakatangirwa neCRS yakagara mazuva makumi mapfumbamwe nemanomwe. Zviratidzo zveHLH/MAS zvinosanganisira hypotension, hypoxia ine diffuse alveolar damage, coagulopathy, cytopenia, uye kusagadzikana kwenhengo dzakawanda, kusanganisira renal dysfunction. HLH idambudziko rinotyisa uye rine huwandu hwevanhu vanofa zvakanyanya kana ikasazivikanwa nekurapwa nekukurumidza. Kurapa kweHLH/MAS kunofanirwa kupihwa maererano nemasangano.
CARVYKTI® REMS: Nekuda kwenjodzi yeCRS uye neurologic toxicities, CARVYKTI® inowanikwa chete kuburikidza nechirongwa chakarambidzwa pasi peRisk Evaluation and Mitigation Strategy (REMS) inonzi CARVYKTI.® REMS.
CYTOPENIAS YAKARERERA UYE AKADZWA: Varwere vanogona kuratidza cytopenias yakareba uye inodzokororwa zvichitevera lymphodepleting chemotherapy uye CARVYKTI® infusion. Mumwe murwere akawana autologous stem cell therapy ye hematopoietic reconstitution nekuda kwekugara kwenguva refu thrombocytopenia.
MuCARTITUDE-1, 30% (29/97) yevarwere vakawana kwenguva yakareba Giredhi 3 kana 4 neutropenia uye 41% (40/97) yevarwere vakawana kwenguva yakareba Giredhi 3 kana 4 thrombocytopenia iyo yakanga isati yagadziriswa neZuva 30 ichitevera ciltacabtagene autoleucel infusion.
Recurrent Giredhi 3 kana 4 neutropenia, thrombocytopenia, lymphopenia uye anemia zvakaonekwa mu63% (61/97), 18% (17/97), 60% (58/97), uye 37% (36/97) mushure mekupora kubva. yekutanga Giredhi 3 kana 4 cytopenia inotevera infusion. Mushure meZuva 60 rinotevera ciltacabtagene autoleucel infusion, 31%, 12% uye 6% yevarwere vaiva nekudzoka kweGrade 3 kana kupfuura lymphopenia, neutropenia uye thrombocytopenia, zvichienderana, mushure mekutanga kupora kweGrade 3 kana 4 cytopenia. Makumi masere nenomwe kubva muzana (84/97) yevarwere vaive neimwe, mbiri, kana zvitatu kana kupfuura zveGrade 3 kana 4 cytopenias mushure mekutanga kupora kweGrade 3 kana 4 cytopenia. Vatanhatu uye 11 varwere vaiva neGiredhi 3 kana 4 neutropenia uye thrombocytopenia, maererano, panguva yekufa.
Chengetedza kuverenga kweropa pamberi uye shure kweCARVYKTI® infusion. Tonga cytopenias nekukura zvinhu uye tsigiro yekuwedzerwa ropa chigadzirwa zvinoenderana nenharaunda yenzvimbo nhungamiro.
KUSVIRA: CARVYKTI® haifanirwe kupihwa kune varwere vane hutachiona hunoshanda kana hutachiona hwehutachiona. Zvirwere zvakanyanya, zvinotyisa kana zvinouraya zvakaitika kune varwere mushure meCARVYKTI® kusanganisa.
Utachiona (magiredhi ese) akaitika mu57 (59%) varwere. Zvirwere zveGrade 3 kana 4 zvakaitika muchikamu che23% (22/97) chevarwere; Zvirwere zveGiredhi 3 kana 4 zvine hutachiona husina kutaurwa hwakaitika mu17%, hutachiona hwehutachiona mu7%, hutachiona hwehutachiona mu1%, uye fungal hutachiona mu1% yevarwere. Pakazere, varwere vana vaive nezvirwere zveGrade 5: abscess yemapapu (n=1), sepsis (n=2) nemabayo (n=1).
Tarisa varwere kune zviratidzo uye zviratidzo zvehutachiona pamberi uye shure kweCARVYKTI® infusion uye kurapa varwere zvakakodzera. Gadzira prophylactic, pre-emptive uye / kana kurapa antimicrobials maererano neyakajairwa masangano nhungamiro. Febrile neutropenia yakaonekwa mu10% yevarwere mushure mekuiswa kweciltacabtagene autoleucel, uye inogona kunge yakafanana neCRS. Muchiitiko chefebrile neutropenia, ongorora hutachiona uye gadzirisa ne-broad-spectrum antibiotics, zvinwiwa uye kumwe kutarisira kunotsigira, sezvinoratidzwa nemishonga.
Viral Reactivation: Hepatitis B virus (HBV) reactivation, mune dzimwe nguva inokonzera fulminant hepatitis, hepatic kukundikana uye kufa, inogona kuitika kune varwere vane hypogammaglobulinemia. Ita kuongororwa kweCytomegalovirus (CMV), HBV, hepatitis C virus (HCV), uye hutachiwana hwehutachiona hwehutachiona (HIV), kana chero humwe hutachiwana hunotapukira kana hunoratidzwa nekliniki maererano nemitemo yekiriniki isati yaunganidzwa masero ekugadzira. Funga nezve antiviral therapy kudzivirira hutachiwana reactivation pamagariro enzvimbo / maitiro ekiriniki.
HYPOGAMMAGLOBULINEMIA yakataurwa sechiitiko chakaipa mu12% (12/97) yevarwere; murabhoritari IgG mazinga akawira pasi pe500 mg/dL mushure mekuisirwa mu92% (89/97) yevarwere. Tarisa mazinga e immunoglobulin mushure mekurapwa neCARVYKTI® uye shandisa IVIG yeIgG <400 mg/dL. Tonga pazvirairo zvenzvimbo, kusanganisira kudzivirira kutapukira uye mishonga inorwisa mabhakitiriya kana antiviral prophylaxis.
Kushandisa Majekiseni Ekurarama: Kuchengetedzeka kwekubaiwa nemishonga mhenyu yehutachiona panguva kana kutevera CARVYKTI.® kurapwa hakuna kudzidzwa. Kudzivirira nemararamiro ehutachiona haakurudzirwi kwemavhiki matanhatu asati atanga lymphodepleting chemotherapy, panguva yeCARVYKTI.® kurapwa, uye kusvika kupora kwekudzivirira mushure mekurapwa neCARVYKTI®.
HYPERSENSITIVITY REACTIONS zvakaitika mu5% (5/97) yevarwere vanotevera ciltacabtagene autoleucel infusion. Serious hypersensitivity reactions, kusanganisira anaphylaxis, inogona kunge yakakonzerwa ne dimethyl sulfoxide (DMSO) muCARVYKTI.®. Varwere vanofanira kunyatsotariswa kwemaawa maviri mushure mokupinza zviratidzo uye zviratidzo zvekunyanya kuita. Bata nekukasira uye gadzirisa zvakakodzera zvichienderana nekuoma kwe hypersensitivity reaction.
CHECHIKORI MARIGNANCES: Varwere vanogona kutanga zvirwere zvechipiri. Chengetedza hupenyu hurefu hwechipiri chechirwere. Kana pakaitika chirwere chechipiri, bata Janssen Biotech, Inc., pa 1-800-526-7736 yekuzivisa uye kuwana mirairo yekuunganidzwa kwevarwere sampuli yekuongororwa kwechipiri kurwara kweT cell kwakabva.
ZVINOGONESESA PAMUSORO PAKUKWANISA KUTYAIRA NEKUSHANDISA MACHINA Pamusana pekugona kwezviitiko zveurological, kusanganisira kuchinjwa kwepfungwa, kugumburwa, neurocognitive kuderera, kana neuropathy, varwere vari pangozi yekuchinja kana kuderera kwekuziva kana kurongeka mumavhiki e8 anotevera CARVYKTI.® infusion. Rairira varwere kuti varambe kutyaira uye kuita mabasa ane njodzi, sekushandisa michina inorema kana inogona kuva nengozi panguva ino yekutanga, uye kana pakaitika kutsva kwechero neurologic toxicity.
ZVAKAITIKA ZVAKAITIKA
Izvo zvinowanzoitika zvisiri zverabhoritari zvakaipa (zviitiko zvinopfuura 20%) pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal kurwadziwa, kuneta, utachiona hwehutachiona husina kutaurwa, kukosora, kupindwa nechando, manyoka, kusvotwa, encephaliteopathy, kuderera kwe appetite. chirwere chekufema, kutemwa nemusoro, tachycardia, dzungu, dyspnea, edema, hutachiona hwehutachiona, coagulopathy, kuvimbiswa, uye kurutsa. Kusawirirana kwakanyanya murabhoritari (chiitiko chikuru kupfuura kana kuenzana ne50%) zvinosanganisira thrombocytopenia, neutropenia, anemia, aminotransferase elevation, uye hypoalbuminemia.
CAR T-Cell kurapa iri pakati pekurapa kunobudirira kwemamwe marudzi egomarara reropa. Kune anopfuura 750 arikuenderera mberi kliniki miedzo in CAR T-Cell kurapa muChina parizvino. Varwere vanoda kunyoresa vanogona kubata CancerFax runhare rwekubatsira murwere paWhatsApp + 91 96 1588 1588 kana email ku info@cancerfax.com.
Ndapota verenga zvizere Kunyora Ruzivo kusanganisira Bhokisi Yambiro yeCARVYKTI®.
PANE CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)
Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.[1]
Muna Zvita 2017, Legend Biotech yakapinda muchibvumirano cherezenisi chepasi rose nekubatana neJanssen Biotech, Inc. (Janssen) kugadzira nekutengesa cilta-cel.
Muna Kukadzi 2022, cilta-cel yakabvumidzwa neUS Food and Drug Administration (FDA) pasi pezita rechiratidzo CARVYKTI® kuitira kurapwa kwevanhu vakuru vane myeloma yadzoka kana kuti refractory multiple. Muna Chivabvu 2022, European Commission (EC) yakapa mvumo yekushambadzira yeCARVYKTI® yekurapa vanhu vakuru vane myeloma yakareruka uye inorambidzika. [3] Muna Gunyana 2022, Bazi rezveutano, revashandi nekugara zvakanaka rekuJapan (MHLW) rakatendera CARVYKTI®.[4] Cilta-cel yakapihwa Breakthrough Therapy Designation muUS muna Zvita 2019 uye kuChina muna Nyamavhuvhu 2020. Pamusoro pezvo, cilta-cel yakagamuchira zita rePRIority MEdicines (PRIME) kubva kuEuropean Commission muna Kubvumbi 2019. Cilta-cel akawanawo Orphan Drug Kudomwa kubva kuUS FDA muna Kukadzi 2019, kubva kuEuropean Commission muna Kukadzi 2020, uye kubva kuPharmaceuticals and Medicinal Devices Agency (PMDA) muJapan muna Chikumi 2020. Muna Kurume 2022, European Medicines Agency's Committee yeOrphan Medicinal Products yakakurudzirwa nekubvumirana. kuti zita renherera re cilta-cel richengetedzwe pahwaro hwedhata rekiriniki rinotaridza kuvandudzwa uye kuenderera mberi kwemhinduro dzakakwana dzinotevera kurapwa.
ABOUT MULTIPLE MYELOMA
Multiple myeloma chirwere chisingarapike gomarara reropa that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S. While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.[8] Although treatment may result in remission, unfortunately, patients will most likely relapse. Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few treatment options available.
[1] CARVYKTI™ Kunyora Ruzivo. Horsham, PA: Janssen Biotech, Inc.
[2] CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Yakanangana neCAR-T Therapy, Inogamuchira US FDA Mvumo yeKurapwa kweVarwere Vakura vane Kudzokazve kana Kurambana Kwakawanda kweMyeloma. Inowanikwa pa: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-bcma-directed-car-t-therapy-receives-us-fda-approval-for-the-treatment-of-adult-patients -ne-relapsed-kana-refractory-multiple-myeloma/. Yakasvika muna Gumiguru 2022.
[3] CARVYKTI (ciltacabtagene autoleucel) Yakapiwa Kubvumirwa Kwemitemo neEuropean Commission yeKurapa kweVarwere vane Relapsed and Refractory Multiple Myeloma. Inowanikwa pa: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-granted-conditional-approval-by-the-european-commission-for-the-treatment-of-patients-with-relapsed-and -refractory-multiple-myeloma/. Yakasvika muna Gumiguru 2022.
[4] CARVYKTI™ (ciltacabtagene autoleucel) Inogamuchira Mvumo kubva kuJapan Ministry of Health, Labor and Welfare (MHLW) yekurapwa kwevarwere vane Myeloma Yakadzoka kana Refractory Multiple. Inowanikwa pa: https://www.businesswire.com/news/home/20220926005847/en/CARVYKTI%E2%84%A2-ciltacabtagene-autoleucel-Receives-Approval-from-Japan%E2%80%99s-Ministry-of -Utano-Basa-uye-Welfare-MHLW-ye-Kurapwa-kweVarwere-vane-Vakare-kare-kana-Refractory-Multiple-Myeloma. Yakasvika muna Gumiguru 2022.
[5] European Commission. Community Register yeOrphan Medicinal Products. Inowanikwa pa: https://ec.europa.eu/health/documents/community-register/html/o2252.htm. Yakasvika muna Gumiguru 2022.
[6] American Society yeClinical Oncology. Multiple myeloma: sumo. https://www.cancer.net/cancer-type/multiple-myeloma/introduction. Yakasvika muna Gumiguru 2022.
[7] American Cancer Society. "Nhamba Dzakakosha Nezve Multiple Myeloma." Inowanikwa pa: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370% 20in%20vakadzi). Yakasvika muna Ndira 2023.
[8] American Cancer Society. Multiple myeloma: kutanga kuona, kuongororwa uye kurongwa. https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Yakasvika muna Gumiguru 2022.
[9] Rajkumar SV. Multiple myeloma: 2020 gadziriso pamusoro pekuongororwa, njodzi-stratification uye manejimendi. Ndiri J Hematol. 2020;95(5),548-567. doi:10.1002/ajh.25791.
[10] Kumar SK, Dimopoulos MA, Kastritis E, et al. Nhoroondo yechisikigo yekudzokazve myeloma, refractory kune immunomodulatory zvinodhaka uye proteasome inhibitors: a multicenter IMWG kudzidza. Leukemia. 2017;31(11):2443- 2448.
[11] Gandhi UH, Cornell RF, Lakshman A, et al. Migumisiro yevarwere vane multiple myeloma refractory kune CD38-yakananga monoclonal antibody therapy. Leukemia. 2019;33(9):2266-2275.
ABOUT LEGEND BIOTECH
Legend Biotech ikambani yepasi rose yebiotechnology yakazvipira kurapa, uye rimwe zuva kurapa, zvirwere zvinouraya. Tine muzinda muSomerset, New Jersey, tiri kugadzira epamberi sero kurapwa munzvimbo dzakasiyana siyana dzetekinoroji mapuratifomu, anosanganisira autologous uye allogeneic chimeric antigen receptor T-cell, gamma-delta T cell (gd T) uye muurayi wechisikigo (NK) cell-based. immunotherapy. Kubva kunzvimbo dzedu nhatu dzeR&D pasirese, tinoshandisa tekinoroji iyi yekutsvaga kuwanikwa kweakachengeteka, anoshanda uye anocheka-kumucheto marapirwo evarwere pasi rese.
