Cilta-Cel kurapwa kweakawanda myeloma kurapwa

nekuti inogadzirwa kubva kumasero ako machena eropa akashandurwa (genetically modified) kuziva uye kuparadza masero ako akawanda emyeloma, Cilta-Cel CAR T-Cell kurapwa (ciltacabtagene autoleucel) yakasiyana nemimwe mishonga yegomarara inowanzoshandiswa (senge chemotherapy). 

Legend Biotech Corporation yakataura kuti FDA yakabvumidza ciltacabtagene autoleucel (cilta-cel; Carvykti) semushonga wevanhu vakuru vane myeloma yakadzokororwa kana kuti refractory vanga vatova nemitsara mina kana kupfuura yekurapa, senge proteasome inhibitor, immunomodulatory agent, uye anti-CD38 monoclonal antibody.

Iyo FDA yakawedzera nguva yekuongorora ye cilta-cel, chimeric antigen receptor (CAR) T-cell therapy ine maviri single domain masoja ekudzivirira chirwere anonangana neBCMA, kubva 2021 kusvika 2023 kuitira kuti tive nenguva yakakwana yekuongorora ruzivo rwakaunzwa nezve ongororo yakagadziridzwa. nzira iyo yakaitwa mukupindura kune FDA ruzivo chikumbiro.

Huwandu hwekupindura hwese (ORR) hwe98% (95% CI, 92.7% -99.7%) uye kuomarara kweyero yemhinduro yakakwana (SCR) ye78% (95% CI, 68.8% -86.1%) yakawanikwa necilta-cel. inopihwa seyakaiswa kamwe chete pachiyero che 0.5 kusvika 1.0 x 106 CAR-positive inogoneka T masero pakg yehuremu hwemuviri muchikamu 1/2 CARITUDE kiriniki yekuedza (NCT035 Masero eCAR T akakurudzira kuita kwakasimba uye kwakadzama. nguva yepakati yekupindura yaive mwedzi ye21.8 (95% CI, 21.8 kuti isingafungidzike) panguva yekutevera yemwedzi ye18. 

Sundar Jagannath, MD, MBBS, purofesa wemishonga, haematology, uye mishonga oncology paGomo reSinai, akashanda semuongorori mukuru wezvidzidzo. "Rwendo rwekurapa kweruzhinji rwevarwere vanorarama nemultiple myeloma inguva isingaregi yekuregererwa uye kudzoka zvakare nevarwere vashoma vanowana mhinduro yakadzama sezvavanofambira mberi kuburikidza nemitsara yekupedzisira yekurapa," akadaro mukuburitswa kwenhau.

1) Chidzidzo cheCARTITUDE-1 zvakawanikwa, izvo zvakaratidza kuti cilta-cel inogona kuunza mhinduro dzakadzika uye dzakasimba uye nguva refu-yemahara isina kurapwa, kunyangwe mune iyi yakawanda pretreated multiple myeloma murwere, zvakakonzera kufarira kwangu nekuda kweizvi. Kubvumidzwa kweCarvykti nhasi kunozadza chinodiwa chakakosha chevarwere ava.

97 vanhu vane relapsed / refractory multiple myeloma vaiva nyaya ye-open-label, single-arm, multi-center CARITUDE kudzidza. Iko muzana yevarwere vakawana zviitiko zvakashata (AEs) uye muzana vakawana maEE akanyanya akashanda sechikamu chekutanga chekupedzisira. ORR yakashanda sechikamu chechipiri chekupedzisira. Vatsvakurudzi vakaongorora kufambira mberi-kusina kupona (PFS), kupona kwese (OS), nguva yekupindura, mazinga eCAR-T masero, mazinga eBCMA-anoratidza masero, mazinga e-soluble BCMA, systemic cytokine concentrations, mazinga eBCMA, hutano- hune hukama hwehupenyu, uye shanduko kubva kune yekutanga-inoenderana nehutano hwehupenyu seyechipiri yekupedzisira mapoinzi.

Chidzidzo chemakore maviri chekutevera zvakawanikwa zvakangotaurwa pamusangano wepagore weAmerican Society of Hematology. Maererano nedheta, maererano nekubudirira, nguva yepakati yekutanga kuita yaive mwedzi 1, uye nguva yepakati yekupedzisa mhinduro kana zvirinani yaive mwedzi miviri (range, 2-1). Pakaongororwa kuvepo kwechirwere chepasirese (MRD) muvarwere makumi mashanu nevanomwe, 15% yavo yakaonekwa kuti haina kunaka. Chiyero chePFS chaive 57% (91.8% CI, 66.0% -95%) uye chiyero cheOS chaive 54.9% (75.0% CI, 80.9% -95%) panguva yemwedzi gumi nemasere. Chiyero chePFS chaive 71.4% uye chiyero cheOS chaive 87.6% muboka revarwere vakange vatsigira MRD kwemwedzi inopfuura 18 uye kupfuura mwedzi ye96.3. PFS yepakati haina kuwanikwa.

2) Neutropenia (94.8%), anemia (68.0%), leukopenia (60.8%), thrombocytopenia (59.8%), uye lymphopenia (49.5%) yaiva pakati pegiredhi 3/4 hematologic yakaipa zviitiko zvakaonekwa. 94.8% yevarwere vaive necytokine release syndrome, iyo yainyanya kuitika mumakiredhi 1 ne2.

Iyo FDA-yakatenderwa label ye cilta-cel inonyora Guillain-Barré syndrome, peripheral neuropathy, cranial nerve palsies, uye hemophagocytic lymphohistiocytosis mukuwedzera kune yakajairika giredhi 3/4 AEs.

Iyo FDA yakapa cilta-cel budiriro uye mazita emishonga yenherera isati yaitendera kuti irapwe varwere vane kudzokazve kana kuti refractory myeloma yakawandisa vanga vawana mitsara mina kana kupfuura yekurapa. Cilta-cel yakaendeswawo kuti itenderwe pasi pechiratidzo ichi muEurope.

Ko Cilta-Cel CAR T-Cell therapy inoshanda sei?

Cilta-Cel therapy CAR T-cell therapy, kana chimeric antigen receptor kurapwa, rudzi rutsva rwe immunotherapy inoshandisa akanyatso mainjiniya T maseru kuti anyatso kunanga maseru egomarara. Masoja ekudzivirira zvirwere anoumbwa nemasero uye nhengo dzinoshanda pamwe chete kuchengetedza muviri kubva kuutachiona negomarara. T masero rudzi rumwe rwesero rinovhima pasi uye rinouraya masero asina kukwana, kusanganisira kenza masero. Nekuti maseru egomarara dzimwe nguva anogona kunzvenga immune system, zvinodikanwa kudzorera immune system kuti izive uye kurwisa cancer maseru. CAR T-cell therapy inzira nyowani yekudzidzisa immune system kurwisa cancer.

Mushure mekuenzanisirwa kwemurwere T maseru anotorwa kubva muropa, maseru anogadzirwazve kuti ave nehumwe hugadziro pamusoro payo unonzi chimeric antigen receptors (CARs). Iwo ma receptors pane aya ma CAR T maseru anogona kubatsira maseru eT pakuziva nekurwisa maseru egomarara mumuviri wese kana aiswa zvakare mumurwere.

CAR T-cell therapy ikozvino yave nerezinesi neFDA sechiyero chekutarisira kune mamwe marudzi ekudzoreredza kana kuramba. Asiri-Hodgkin lymphoma, multiple myeloma, uye pediatric relapsed acute lymphoblastic leukemia (ALL), uye iri kuongororwa mune dzimwe mhando dzekenza yeropa.

CAR T-Cell kurapa inzira yemununotherapy inoshandisa zvakanyatsogadziriswa T-maseru ayo ari chikamu chemuviri wedu immune kurwisa kenza. Muenzaniso wevarwere T masero anounganidzwa kubva muropa, zvino inogadziriswa kuti ibudise zvivako zvakakosha zvinonzi chimeric antigen receptors (CAR) pamusoro pavo. Kana aya masero eCAR akagadziridzwa akadzoserwa mumurwere, aya masero matsva anorwisa chaiyo antigen uye anouraya bundu maseru.

Ndeipi mutengo weCilta-Cel CAR T-Cell therapy?

Parizvino, Cilta-Cel CAR T-Cell therapy inodhura mari inosvika $225,000 USD muChina uye $425,000 USD muUSA. Parizvino, inowanikwa munzvimbo dzakasarudzwa muUS. Nekudaro, miyedzo yakawanda yekiriniki iri kuitika muChina, uye mutengo wavo unotarisirwa kudzikira zvakanyanya kana miedzo mitsva iyi yatenderwa.

Maside effects eCilta-Cell CAR T-Cell therapy

Cilta-Cel (ciltacabtagene autoleucel) inogona kukonzera mhedzisiro yakaoma kana kuuraya uye inogona kutungamirira kurufu. Fonera mutarisiri wako wehutano kana kuwana rubatsiro rwechimbichimbi ipapo kana ukawana chimwe chezvinotevera:

• fivha (100.4°F/38°C kana kupfuura)
• kupindwa nechando kana kudedera
• kushingaira kana kusina kushaya mwoyo
• kunetseka kufema
• yakaderera zvakanyanya BP
• dzungu/musoro wakareruka
• mhedzisiro pane yako sisitimu yetsinga, dzimwe dzacho dzinogona kuitika mazuva kana mavhiki mushure mekunge wagamuchira infusion uye inogona kutanga yakavanzika, senge:
  • kunzwa kuvhiringika, kusvinura kana kuvhiringidzika, kutadza kutaura kana kutaura zvisina kujeka, kutadza kuverenga, kunyora nekunzwisisa mashoko, kutadza ndangariro.
  • kurasikirwa kwekubatana kunokanganisa kufamba uye kuenzanisa, kufamba zvishoma nezvishoma, kuchinja kwekunyora kwemaoko
  • kuchinja kweunhu, kusanganisira kutadza kuratidza manzwiro, kusanyanya kutaura, kusafarira zviitiko, uye kuderedzwa kwechiso
  • kurira, kuita chiveve uye kurwadziwa mumaoko netsoka, kunetseka kufamba, gumbo uye/kana kushaya simba kweruoko, uye kunetseka kufema.
  • chiveve chechiso, kunetseka kufambisa tsandanyama dzechiso nemeso

Cilta-Cel CAR T-Cell kurapwa muChina

MaChinese regulators akapa mukana wekurapa kuLegend Biotech uye yeJanssen yekuferefeta CAR T-cell therapy, ciltacabtagene autoleucel (cilta-cel), semushonga ungangoita wekudonha kana kuramba wakawanda myeloma.

Cilta-cel inoreva zvese JNJ-4528, rinova zita rinozivikanwa naro kurapa kunze kweChina, uye LCAR-B38M, rinova zita raanozivikanwa naro kuChina.

Sarudzo yeNational Medical Products Administration's (NMPA) yeChinese Center for Drug Evaluation's (CDE) inoitirwa kukurumidza kuvandudzwa uye kuongororwa kwemarapirwo ane humbowo hwekutanga hwekiriniki hwevimbiso hukuru kupfuura marapirwo aripo ezvirwere zvakanyanya.

Sekureva kwaburitswa nenhau kubva kuLegend, CEO Frank Zhang, PhD, "Kududzwa kwakakurudzirwa neChina CDE yeNMPA kunoratidza chiitiko chakakosha mukufambisira mberi kwecilta-cel muvarwere vakawanda vemyeloma."

Akaenderera mberi achiti, "Legend icharamba ichiongorora kurapwa uku kuChina nekune dzimwe nyika pamwe chete naJanssen.

Kurapa kwaimbove kwakabata PRIME (Priority Medicines) chitupa kubva kuEuropean Medicines Agency chechiratidzo chakafanana uye dhizaini yekurapa kubva kuUS Food and Drug Administration. Masangano anodzora muUS, EU, Japan, neKorea akauisawo semushonga wenherera.