Januari 27, 2023—Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that CARTITUDE-4, the Phase 3 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma, met its primary endpoint of showing a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the study’s first pre-specified interim analysis. The study has been unblinded following the recommendation of an independent data monitoring committee.
Ulikan CARTITUDE-4 (NCT04181827) mangrupikeun ulikan Fase 3 internasional, randomized, open-label anu ngevaluasi efektivitas sareng kasalametan terapi CAR-T versus pomalidomide, bortezomib sareng dexamethasone (PVd) atanapi daratumumab, pomalidomide sareng dexamethasone (DPd) dina penderita sawawa kalawan relapsed na lenalidomide-refractory sababaraha myeloma anu narima hiji nepi ka tilu garis prior terapi.
Titik ahir utama pangajaran nyaéta PFS. Titik akhir sekundér kalebet kaamanan, kasalametan umum (OS), tingkat négatif residual minimal (MRD) sareng tingkat réspon sakabéh (ORR). Pasén bakal terus dituturkeun pikeun titik tungtung primér sarta sekundér salaku bagian tina ulikan CARTITUDE-4.
“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 sababaraha myeloma in various stages of disease progression,” Lida Pacaud, M.D., Vice President of Clinical Development and Medical Affairs at Legend Biotech, said.
Hasil tina ulikan CARTITUDE-4 bakal dikintunkeun ka rapat médis anu bakal datang sareng bakal ngadukung diskusi sareng otoritas kaséhatan ngeunaan kiriman pangaturan poténsial.
CARVYKTI® Indikasi jeung pamakéan
CARVYKTI® (ciltacabtagene autoleucel) mangrupakeun antigén maturation sél B (BCMA) -sél T autologous dirobah genetik diarahkeun immunotherapy Ditunjukkeun pikeun pengobatan pasien dewasa sareng sababaraha myeloma kambuh atanapi refractory, saatos opat atanapi langkung jalur terapi sateuacana, kalebet inhibitor proteasome, agén immunomodulatory, sareng antibodi monoklonal anti CD38.
PERHATOSAN JEUNG KAGIATAN
CYTOKINE RELEASE SYNDROME (CRS) kaasup réaksi fatal atawa ngancam kahirupan, lumangsung sanggeus perlakuan jeung CARVYKTI® dina 95% (92/97) pasien narima ciltacabtagene autoleucel. Kelas 3 atanapi CRS langkung luhur (kelas ASTCT 2019) lumangsung dina 5% (5/97) pasien, kalayan Kelas 5 CRS dilaporkeun dina 1 pasien. Waktu median ka awal CRS nyaéta 7 dinten (rentang: 1-12 dinten). Manifestasi CRS anu paling umum kalebet pyrexia (100%), hipotensi (43%), paningkatan aspartate aminotransferase (AST) (22%), tiis (15%), paningkatan alanin aminotransferase (ALT) (14%) sareng tachycardia sinus. 11%). Kajadian kelas 3 atanapi saluhureuna anu aya hubunganana sareng CRS kalebet paningkatan AST sareng ALT, hiperbilirubinemia, hipotensi, pyrexia, hypoxia, gagal engapan, tatu ginjal akut, koagulasi intravaskular disebarkeun, HLH / MAS, angina pectoris, tachycardia supraventricular sareng ventricular, malaise, myalgia, ningkat. Protéin C-réaktif, ferritin, fosfatase basa getih sareng transferase gamma-glutamyl.
Identipikasi CRS dumasar kana presentasi klinis. Evaluasi pikeun sareng ngubaran panyabab muriang, hipoksia, sareng hipotensi anu sanés. CRS dilaporkeun aya hubunganana sareng papanggihan HLH / MAS, sareng fisiologi sindrom tiasa tumpang tindih. HLH/MAS mangrupikeun kaayaan anu berpotensi ngancam kahirupan. Dina pasien kalayan gejala progresif CRS atanapi CRS refractory sanajan perlakuan, evaluate pikeun bukti HLH / MAS.
Genep puluh salapan tina 97 (71%) pasien nampi tocilizumab sareng / atanapi kortikosteroid pikeun CRS saatos infus ciltacabtagene autoleucel. Opat puluh opat (45%) pasien nampi ngan tocilizumab, anu 33 (34%) nampi dosis tunggal sareng 11 (11%) nampi langkung ti hiji dosis; Pasén 24 (25%) nampi tocilizumab sareng kortikosteroid, sareng hiji pasien (1%) ngan ukur nampi kortikosteroid. Pastikeun yén sahenteuna dua dosis tocilizumab sayogi sateuacan infus CARVYKTI.®.
Monitor pasien sahenteuna unggal dinten salami 10 dinten saatos CARVYKTI® infusion di fasilitas kasehatan REMS-Certified pikeun tanda jeung gejala CRS. Pantau pasien pikeun tanda atanapi gejala CRS sahenteuna sahenteuna 4 minggu saatos infus. Dina tanda mimiti CRS, geura institut perlakuan kalayan perawatan supportive, tocilizumab, atawa tocilizumab na corticosteroids.
Piwuruk penderita pikeun milari perawatan médis saharita kedah tanda atanapi gejala CRS lumangsung iraha waé.
TOXICITIS NEUROLOGIC, nu bisa jadi parna, ngancam kahirupan atawa fatal, lumangsung sanggeus perlakuan jeung CARVYKTI®. Toksisitas neurologis kalebet ICANS, karacunan neurologis kalayan tanda sareng gejala parkinsonisme, Sindrom Guillain-Barré, neuropathies periferal, sareng paralisis saraf kranial. Naséhat pasien ngeunaan tanda-tanda sareng gejala karacunan neurologis ieu, sareng ngeunaan sifat telat tina awal sababaraha karacunan ieu. Maréntahkeun penderita neangan perhatian médis saharita pikeun assessment salajengna jeung manajemén lamun tanda atawa gejala salah sahiji toxicities neurologic ieu lumangsung iraha wae.
Gemblengna, hiji atawa leuwih subtypes of karacunan neurologic digambarkeun di handap lumangsung sanggeus ciltacabtagene autoleucel di 26% (25/97) pasien, nu 11% (11/97) pasien ngalaman Kelas 3 atawa acara saluhureuna. Subtipe karacunan neurologis ieu ogé dititénan dina dua studi anu lumangsung.
Sindrom Neurotoxicity-Sél-Associated Immune Effector (ICANS): Pasén tiasa ngalaman ICANS anu fatal atanapi ngancam kahirupan saatos perawatan sareng CARVYKTI.®, kaasup saméméh awal CRS, concurrently kalawan CRS, sanggeus resolusi CRS, atawa dina henteuna CRS. ICANS lumangsung dina 23% (22/97) pasien narima ciltacabtagene autoleucel kaasup Kelas 3 atawa 4 kajadian dina 3% (3/97) jeung Kelas 5 (fatal) kajadian dina 2% (2/97). Waktu median pikeun awal ICANS nyaéta 8 dinten (rentang 1-28 dinten). Sadaya 22 pasien kalayan ICANS ngagaduhan CRS. Manifestasi ICANS anu paling sering (≥5%) kalebet encephalopathy (23%), aphasia (8%) sareng nyeri sirah (6%).
Monitor pasien sahenteuna unggal dinten salami 10 dinten saatos CARVYKTI® infus di fasilitas kasehatan anu disertipikasi REMS pikeun tanda sareng gejala ICANS. Ngaluarkeun panyabab séjén tina gejala ICANS. Pantau pasien pikeun tanda atanapi gejala ICANS sahenteuna sahenteuna 4 minggu saatos infus sareng ngubaran langsung. Toksisitas neurologis kedah diurus kalayan perawatan anu ngadukung sareng / atanapi kortikosteroid upami diperyogikeun.
Parkinsonism: Tina 25 penderita dina ulikan CARTITUDE-1 ngalaman neurotoxicity sagala, lima penderita lalaki miboga karacunan neurologic kalawan sababaraha tanda na gejala parkinsonism, béda ti effector imun sél-pakait neurotoxicity sindrom (ICANS). Toksisitas neurologis sareng parkinsonisme parantos dilaporkeun dina uji coba ciltacabtagene autoleucel. Pasén ngagaduhan gejala parkinsonian sareng non-parkinsonian anu kalebet tremor, bradykinesia, gerakan involuntary, stereotypy, leungitna gerakan spontan, masked facies, apatis, flat affect, kacapean, rigidity, retardation psikomotor, micrographia, dysgraphia, apraxia, létoy, kabingungan, somnolence. , leungitna eling, refleksnya nyangsang, hyperreflexia, leungitna ingetan, kasusah neureuy, incontinence bowel, ragrag, stooped sikep, shuffling gait, lemah otot sarta wasting, disfungsi motor, motor jeung leungitna indrawi, mutism akinetic, sarta lobus frontal tanda release. Awal median parkinsonism dina 5 pasien di CARTITUDE-1 nyaéta 43 dinten (rentang 15-108) tina infus ciltacabtagene autoleucel.
Monitor pasien pikeun tanda sareng gejala parkinsonisme anu tiasa ditunda dina awal sareng diurus kalayan ukuran perawatan anu ngadukung. Aya informasi efficacy kawates kalawan pangobatan dipaké pikeun pengobatan kasakit Parkinson, pikeun perbaikan atawa resolusi gejala parkinsonism sanggeus CARVYKTI.® perlakuan.
Sindrom Guillain-Barré: Hasil fatal saatos Sindrom Guillain-Barré (GBS) parantos kajantenan dina ulikan anu sanés ngeunaan ciltacabtagene autoleucel sanaos dirawat ku immunoglobulin intravena. Gejala dilaporkeun kalebet anu konsisten sareng varian Miller-Fisher tina GBS, encephalopathy, kalemahan motor, gangguan ucapan sareng polyradiculoneuritis.
Monitor pikeun GBS. Evaluate penderita presenting kalawan neuropathy periferal pikeun GBS. Pertimbangkeun pengobatan GBS kalayan ukuran perawatan anu ngadukung sareng digabungkeun sareng immunoglobulin sareng pertukaran plasma, gumantung kana parahna GBS.
Periferal Neuropathy: Genep penderita di CARTITUDE-1 dimekarkeun neuropathy periferal. Neuropathies ieu digambarkeun salaku neuropathies indrawi, motor atawa sensorimotor. Waktu median awal gejala nyaéta 62 dinten (rentang 4-136 dinten), durasi median neuropathies periferal nyaéta 256 dinten (rentang 2-465 dinten) kalebet jalma anu neuropathy lumangsung. Pasén anu ngalaman neuropathy periferal ogé ngalaman palsies saraf kranial atanapi GBS dina percobaan lumangsung séjén ciltacabtagene autoleucel.
Cranial Nerve Palsies: Tilu pasien (3.1%) ngalaman palsies saraf kranial dina CARTITUDE-1. Katiluna penderita miboga palsy saraf kranial 7; hiji pasien ngagaduhan palsy saraf kranial ka-5 ogé. Waktu rata-rata awal nyaéta 26 dinten (rentang 21-101 dinten) saatos infus ciltacabtagene autoleucel. Lumangsungna palsy saraf kranial ka-3 sareng ka-6, palsy saraf kranial ka-7 bilateral, parah palsy saraf kranial saatos perbaikan, sareng lumangsungna neuropathy periferal dina pasien anu palsy saraf kranial ogé parantos dilaporkeun dina uji coba ciltacabtagene autoleucel. Monitor pasien pikeun tanda sareng gejala paralisis saraf kranial. Pertimbangkeun manajemén kalayan kortikosteroid sistemik, gumantung kana parah sareng kamajuan tanda sareng gejala.
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): HLH fatal lumangsung dina hiji pasien (1%), 99 poé sanggeus ciltacabtagene autoleucel. Acara HLH dimimitian ku CRS berkepanjangan salami 97 dinten. Manifestasi HLH / MAS kalebet hypotension, hypoxia kalayan karusakan alveolar diffuse, koagulopathy, cytopenia, sareng disfungsi multi-organ, kalebet disfungsi ginjal. HLH mangrupikeun kaayaan anu ngancam kahirupan kalayan tingkat kematian anu luhur upami henteu dikenal sareng dirawat awal. Perlakuan HLH/MAS kudu dilaksanakeun nurutkeun standar institusional.
CARVYKTI® REMS: Kusabab résiko CRS jeung karacunan neurologic, CARVYKTI® ngan sadia ngaliwatan program diwatesan dina hiji Risk Evaluation and Mitigation Strategy (REMS) disebut CARVYKTI.® REMS.
CYTOPENIAS berkepanjangan jeung kambuh: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion. One patient underwent autologous stem cell therapy for hematopoietic reconstitution due to prolonged thrombocytopenia.
Dina CARTITUDE-1, 30% (29/97) pasien ngalaman neutropenia Kelas 3 atanapi 4 berkepanjangan sareng 41% (40/97) pasien ngalaman trombositopenia Kelas 3 atanapi 4 berkepanjangan anu teu acan direngsekeun ku dinten 30 saatos infus ciltacabtagene autoleucel.
Neutropenia Kelas 3 atanapi 4 kambuh, trombositopenia, limfopenia sareng anémia katingal dina 63% (61/97), 18% (17/97), 60% (58/97), sareng 37% (36/97) saatos pulih. Kelas awal 3 atanapi 4 cytopenia saatos infus. Saatos dinten 60 saatos infus ciltacabtagene autoleucel, 31%, 12% sareng 6% pasien ngagaduhan kambuh limfopenia Kelas 3 atanapi langkung luhur, neutropenia sareng thrombocytopenia, masing-masing, saatos pamulihan awal cytopenia Kelas 3 atanapi 4. Dalapan puluh tujuh persén (84/97) pasien ngagaduhan hiji, dua, atanapi tilu atanapi langkung kambuh kelas 3 atanapi 4 cytopenias saatos pamulihan awal cytopenia Kelas 3 atanapi 4. Genep sareng 11 pasien ngagaduhan neutropenia kelas 3 atanapi 4 sareng thrombocytopenia, masing-masing, dina waktos maot.
Monitor jumlah getih sateuacan sareng saatos CARVYKTI® infusan. Atur cytopenias kalawan faktor pertumbuhan sarta rojongan transfusi produk getih nurutkeun tungtunan institusional lokal.
KOMUNITAS: CARVYKTI® teu kudu dikaluarkeun pikeun penderita inféksi aktif atawa gangguan radang. Inféksi parna, ngancam kahirupan atanapi fatal lumangsung dina pasien saatos CARVYKTI® infus.
Inféksi (sadayana sasmita) lumangsung dina 57 (59%) pasien. Inféksi kelas 3 atanapi 4 lumangsung dina 23% (22/97) pasien; Inféksi kelas 3 atanapi 4 sareng patogén anu teu dipikanyaho lumangsung dina 17%, inféksi virus dina 7%, inféksi baktéri dina 1%, sareng inféksi jamur dina 1% pasien. Gemblengna, opat pasien ngagaduhan inféksi Kelas 5: bisul paru (n = 1), sepsis (n = 2) sareng pneumonia (n = 1).
Ngawas pasien pikeun tanda sareng gejala inféksi sateuacan sareng saatos CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 10% of patients after ciltacabtagene autoleucel infusion, and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated.
Reaktivasi Viral: Reaktivasi virus Hépatitis B (HBV), dina sababaraha kasus nyababkeun hépatitis fulminant, gagal hépatik sareng maot, tiasa lumangsung dina pasien anu hypogammaglobulinemia. Laksanakeun saringan pikeun Cytomegalovirus (CMV), HBV, virus hépatitis C (HCV), sareng virus immunodeficiency manusa (HIV), atanapi agén inféksi sanés upami sacara klinis dituduhkeun saluyu sareng pedoman klinis sateuacan ngumpulkeun sél pikeun manufaktur. Pertimbangkeun terapi antiviral pikeun nyegah réaktivasi virus per tungtunan institusional lokal / prakték klinis.
HIPOGAMMAGLOBULINEMIA dilaporkeun salaku acara ngarugikeun dina 12% (12/97) pasien; tingkat IgG laboratorium turun handap 500 mg / dL sanggeus infusion di 92% (89/97) pasien. Monitor tingkat immunoglobulin saatos perlakuan sareng CARVYKTI® sarta administer IVIG pikeun IgG <400 mg/dL. Atur per tungtunan institusional lokal, kaasup precautions inféksi jeung antibiotik atawa antiviral prophylaxis.
Pamakéan Vaksin Langsung: Kasalametan imunisasi sareng vaksin virus hirup salami atanapi saatos CARVYKTI® perlakuan teu acan ditalungtik. Vaksinasi sareng vaksin virus hirup henteu disarankeun sahenteuna 6 minggu sateuacan ngamimitian kémoterapi lymphodepleting, salami CARVYKTI.® perlakuan, jeung nepi ka recovery imun sanggeus perlakuan jeung CARVYKTI®.
Réaksi hipersensitivitas geus lumangsung dina 5% (5/97) pasien sanggeus ciltacabtagene autoleucel infusion. Réaksi hipersensitivitas anu serius, kalebet anafilaksis, tiasa disababkeun ku dimétil sulfoksida (DMSO) dina CARVYKTI.®. Pasén kedah diawaskeun sacara saksama salami 2 jam saatos infus pikeun tanda sareng gejala réaksi parna. Ngubaran gancang-gancang sareng ngatur sacara tepat dumasar kana parah réaksi hipersensitivitas.
MALIGNASI SEKUNDER: Pasén bisa ngamekarkeun malignancies sekundér. Ngawas hirup-panjang pikeun malignancies sekundér. Dina acara anu lumangsung malignancy sekundér, ngahubungan Janssen Biotech, Inc., di 1-800-526-7736 pikeun ngalaporkeun sareng kéngingkeun pitunjuk ngeunaan ngumpulkeun sampel pasien pikeun nguji malignancy sekundér asal sél T.
Épék kana kamampuan pikeun nyetir sareng ngagunakeun mesin: Kusabab potensi kajadian neurologic, kaasup status méntal dirobah, seizures, turunna neurocognitive, atawa neuropathy, penderita aya dina resiko pikeun robah atawa turun eling atawa koordinasi dina 8 minggu sanggeus CARVYKTI.® infusan. Nyarankeun pasien pikeun nolak nyetir sareng ngalaksanakeun padamelan atanapi kagiatan anu ngabahayakeun, sapertos ngoperasikeun mesin beurat atanapi berpotensi bahaya salami periode awal ieu, sareng upami aya karacunan neurologis anu anyar.
RÉKAAN SÉBOR
Réaksi ngarugikeun non-laboratorium anu paling umum (kajadian langkung ageung ti 20%) nyaéta pyrexia, sindrom sékrési sitokin, hypogammaglobulinemia, hipotensi, nyeri musculoskeletal, kacapean, inféksi patogén anu teu dipikanyaho, batuk, chills, diare, seueul, encephalopathy, turun napsu, luhur. inféksi saluran pernapasan, nyeri sirah, tachycardia, pusing, dyspnea, busung lapar, inféksi viral, koagulopathy, kabebeng, sarta utah. Réaksi ngarugikeun laboratorium anu paling umum (kajadian langkung ageung atanapi sami sareng 50%) kalebet thrombocytopenia, neutropenia, anemia, élévasi aminotransferase, sareng hypoalbuminemia.
Terapi T-Cell mobil mangrupikeun salah sahiji pangobatan terobosan pikeun sababaraha jinis kanker getih. Aya leuwih ti 750 lumangsung percobaan klinis in Terapi T-Cell CAR di Cina ayeuna. Pasén anu badé ngadaptar tiasa ngahubungi KankerFax saluran pitulung pasien dina WhatsApp + 91 96 1588 1588 atanapi email ka info@cancerfax.com.
Mangga baca lengkep Émbaran resep kaasup Boxed Warning pikeun CARVYKTI®.
Ngeunaan CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)
Ciltacabtagene autoleucel nyaéta immunotherapy sél T autologous anu diarahkeun ku BCMA, anu dirobih sacara genetik, anu ngalibatkeun program ulang T-sél pasien sorangan sareng transgene encoding a reséptor antigen chimeric (CAR) anu ngaidentipikasi sareng ngaleungitkeun sél anu nganyatakeun BCMA. BCMA utamana dikedalkeun dina beungeut malignant sababaraha myeloma sél B-nasab, kitu ogé tahap ahir B-sél jeung sél plasma. Protéin cilta-cel CAR gaduh dua antibodi domain tunggal anu nargétkeun BCMA anu dirancang pikeun masihan avidity tinggi ngalawan BCMA manusa. Saatos ngariung kana sél-sél anu nyatakeun BCMA, CAR ngamajukeun aktivasina, ékspansi, sareng ngaleungitkeun sél-sél T-sél.[1]
Dina Désémber 2017, Legenda Biotéh diasupkeun kana hiji lisénsi éksklusif di sakuliah dunya sarta pasatujuan kolaborasi jeung Janssen Biotech, Inc. (Janssen) pikeun ngembangkeun sarta commercialize cilta-cel.
In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma.[3] In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®.[4] Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.
Ngeunaan sababaraha myeloma
Multiple myeloma is an incurable kanker getih 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] Émbaran Resep CARVYKTI™. Horsham, PA: Janssen Biotech, Inc.
[2] CARVYKTI™ (ciltacabtagene autoleucel), Terapi CAR-T anu diarahkeun BCMA, Narima Persetujuan FDA AS pikeun Pangobatan Pasén Dewasa sareng Multiple Myeloma Kambuh atanapi Refractory. Sadia di: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-bcma-directed-car-t-therapy-receives-us-fda-approval-for-the-treatment-of-adult-patients -kalawan-kambuh-atawa-refractory-multiple-myeloma /. Diaksés Oktober 2022.
[3] CARVYKTI (ciltacabtagene autoleucel) Dibeunangkeun Persetujuan Sarat ku Komisi Éropa pikeun Perawatan Pasén anu Kambuh sareng Refractory Multiple Myeloma. Sadia di: 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/. Diaksés Oktober 2022.
[4] CARVYKTI™ (ciltacabtagene autoleucel) Narima Persetujuan ti Kamentrian Kaséhatan, Buruh sareng Kesejahteraan Jepang (MHLW) pikeun Perawatan Pasén anu Kambuh atanapi Refractory Multiple Myeloma. Sadia di: https://www.businesswire.com/news/home/20220926005847/en/CARVYKTI%E2%84%A2-ciltacabtagene-autoleucel-Receives-Approval-from-Japan%E2%80%99s-Ministry-of -Kaséhatan-Buruh-na-Karaharjaan-MHLW-pikeun-nu-Perlakuan-of-Pasén-kalawan-kambuh-atawa-Refractory-Multiple-Myeloma. Diaksés Oktober 2022.
[5] Komisi Éropa. Daptar Komunitas Produk Obat Yatim. Sadia di: https://ec.europa.eu/health/documents/community-register/html/o2252.htm. Diaksés Oktober 2022.
[6] Amérika Society of Onkologi klinis. Sababaraha myeloma: bubuka. https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Diaksés Oktober 2022.
[7] Amérika Kangker Society. "Statistik konci Ngeunaan Multiple Myeloma." Sadia di: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370% 20 dina% 20 awéwé). Diaksés Januari 2023.
[8] Amérika Kangker Society. Multiple myeloma: deteksi dini, diagnosis sareng pementasan. https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Diaksés Oktober 2022.
[9] Rajkumar SV. Multiple myeloma: Update 2020 ngeunaan diagnosis, stratifikasi résiko sareng manajemén. Am J Hematol. 2020;95(5),548-567. doi: 10.1002/ajh.25791.
[10] Kumar SK, Dimopoulos MA, Kastritis E, et al. Sajarah alam myeloma kambuh, refractory kana ubar immunomodulatory na sambetan proteasome: ulikan multisenter IMWG. Leukemia. 2017;31(11):2443-2448.
[11] Gandhi UH, Cornell RF, Lakshman A, et al. Hasil pasien kalayan sababaraha myeloma refractory kana terapi antibodi monoklonal sasaran CD38. Leukemia. 2019;33(9):2266-2275.
Ngeunaan Legenda BIOTECH
Legenda Biotech mangrupikeun perusahaan biotéhnologi global anu dikhususkeun pikeun ngubaran, sareng hiji dinten nyageurkeun, panyakit anu ngancam kahirupan. Kantor pusatna di Somerset, New Jersey, kami nuju ngembangkeun terapi sél canggih dina rupa-rupa platform téknologi, kalebet autologous sareng allogeneic chimeric antigen reséptor T-cell, gamma-delta T cell (gd T) sareng natural killer (NK) dumasar sél. immunotherapy. Tina tilu situs R&D kami di sakumna dunya, kami nerapkeun téknologi inovatif ieu pikeun ngudag panemuan terapi anu aman, mujarab sareng canggih pikeun pasien di sakuliah dunya.
