Vailaʻau Aneti-Kanesa Acalabrutinib: Togafitiga Mo CLL / SLL / MCL - AASraw
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Vailaau Aneti-Kanesa Acalabrutinib

 

  1. Acalabrutinib Backgroud
  2. Acalabrutinib iloiloga
  3. Togafitiga Acalabrutinib (Faʻaaoga mo)
  4. Acalabrutinib Faʻatinoina o gaioiga
  5. O a ni aʻafiaga e ono tutupu i le Acalabrutinib?
  6. Acalabrutinib VS Ibrutinib
  7. Suesuega: Acalabrutinib I le togafitia o le kanesa o le lymphocytic leukemia (CLL)

 

Acalabrutinib Backgroud

I le taimi nei, acalabrutinib na faʻaaogaina i faʻataʻitaʻiga suʻesuʻeina le togafitiga o B-All, Myelofibrosis, Ovarian Cancer, Multiple Myeloma, ma Hodgkin Lymphoma, ma isi.

E oʻo ia Oketopa 31, 2017 ua faʻamaonia e le FDA le faʻatonutonuga tuʻuina a le Astra Zeneca (acalabrutinib). O lenei taofi o le Bruton Tyrosine Kinase (BTK) na faʻailoa mai mo le togafitia o le lymphocytic leukemia faaumiumi, lymphocytic lymphoma laʻititi, ma tagata matutua o loʻo i ai le Mantle Cell Lymphoma (MCL) ua uma ona mauaina le tasi muamua togafitiga.

E lauiloa foi ACP-196, acalabrutinib e taʻua foi o le isi augatupulaga BTK taofiofia ona na fuafua tatau e sili atu le malosi ma filifili nai lo ibrutinib, theoretically faamoemoe e faʻaalia ai ni nai faʻafitauli leaga ona o le faʻaitiitia o aafiaga vavalalata i faʻamoemoega nai lo le BTK.

Ae ui i lea, acalabrutinib na faʻamaonia i lalo o le alualu i luma a le FDA auala faʻamaonia, lea e faʻavae i luga o le aotelega tali fua faatatau ma faʻafaigofieina muamua faʻamaonia o vailaʻau e togafitia tulaga ogaoga poʻo / ma e faʻatumuina se le faʻamalieina manaʻomia fomaʻi faʻavae luga o le sui faʻaiuga. Faʻaauau le faʻamaonia mo le acalabrutinib's o loʻo talia nei faʻailoga e ono mulimuli ane faʻalagolago i le faʻaauauina o le faʻamaonia ma le faʻamatalaina o le falemaʻi penefiti i confimatory tofotofoga.

E le gata i lea, na faʻatagaina e le FDA lenei vailaʻau Faʻamuamua Iloiloga ma Breakthrough Therapy igoa. Na mauaina foi le Orphan Drug designations, lea e maua ai lagona faʻaosofia e fesoasoani ma faʻamalosia le atinaʻeina o vailaʻau mo faʻamaʻi seasea. Ile taimi nei, e ova atu ile 35 faʻataʻitaʻi ole falemaʻi ile 40 atunuʻu ma e ova atu ile 2500 tagata mamaʻi o loʻo faʻagasolo pe ua maeʻa foʻi e tusa ai ma nisi suʻesuʻega ile malamalamaaga atili ma le faʻalauteleina ole faʻaogaina o togafitiga ole acalabrutinib 5.

 

Acalabrutinib iloiloga

Acalabrutinib (CAS:1420477-60-6), lea e faʻatau atu i lalo ole igoa ole Calquence® ile US ma Kanata, ose augatupulaga lona lua ole mole laʻititi e taofia le Bruton's tyrosine kinase (BTK). I luga o le tautala tuʻu, acalabrutinib fusifusia ma le le toe mafai ona taofia le gaioiga a le BTK e puipuia uma B-sela faʻagaoioia ma B-sela-faʻatulagaina faailo. O lenei gaioiga e oʻo atu ai i le taofiofia o le tuputupu aʻe o sela leaga o le B o lo o soona faʻailoa ai le BTK. E manaʻomia le BTK mo le faʻailogaina ole B-cell, e iai sona sao taua ile faʻatupulaia o le B-cell, ma e ova le faʻamatalaina ile tele o faʻamaʻi B-cell, e aofia ai le CLL / SLL. O le faʻaalia o le BTK i sela tuma e fesoʻotaʻi ma le faʻateleina o le faʻateleina ma le ola. I le avea ai o le lua-augatupulaga BTK taofi, acalabrutinib na fuafuaina e faʻateleina ai le aʻafiaga o le BTK ma faʻaitiitia ai le faʻatinoina o gaioiga i luga o le TEC (Tec Protein Tyrosine Kinase), EGFR (epidermal grow factor receptor), ma le ITK (interleukin-2-inducible T- sela kinase). O le augatupulaga muamua BTK taofi, ibrutinib (Imbruvica), leai se mea faʻapitoa lea e mafua ai le maualuga o aʻafiaga o aʻafiaga. I se faʻaopopoga i le CLL / SLL, acalabrutinib e faʻamaonia mo Mantle Cell Lymphoma (MCL). O le National Cancer Center Network (NCCN) Taiala lisi acalabrutinib ma pe leai obinituzumab o muamua laina togafitiga mo CLL / SLL faʻapea foi talafeagai mo le faʻaaogaina i relapsed po refactory (R / R) CLL.

 

Acalabrutinib Togafitiga (Faʻaaoga mo)

O le Acalabrutinib e faʻaaoga e togafitia ai tagata ma le mantle cell lymphoma (MCL; o se kanesa tuputupu aʻe e amata i sela o le puipuiga o le tino) ua uma na togafitia ma le le itiiti ifo i le tasi isi chemotherapy vailaʻau.

O le Acalabrutinib e faʻaaogaina na o ia poʻo le obinutuzumab (Gazyva) e togafitia ai maʻi lemonia o le lymphocytic tumau (CLL; o se ituaiga o kanesa e amata i totonu o sela papaʻe toto) ma laiti lymphocytic lymphoma (SLL: o se ituaiga o kanesa e amata ile sela papaʻe).

O le Acalabrutinib o loʻo i totonu o le vasega o vailaʻau e taʻua o le kinase inhibitors. E galue e ala i le polokaina o le gaioiga o le le masani ai polotini e faʻailoaina sela kanesa ia uluola. E fesoasoani lea e taofi le sosolo o sela kanesa.

 

Acalabrutinib Faʻamau Of Afaʻasologa

Mantle Cell Lymphoma (MCL) o se ituaiga seasea ae faʻasauā o le B-cell non-Hodgkin lymphoma (NHL) ma leaga le vavalo. Mulimuli ane, toe tupu e masani i MCL tagata mamaʻi ma mulimuli ane sui faʻamaʻi alualu i luma.

E tupu le Lymphoma pe a tupuola le faʻamalosi tino lymphocytes ma faʻateleina ma le le taofiofia. O ia lymphocytes kanesa atonu e malaga i le tele o vaega o le tino, e aofia ai le lymph nodes, spleen, ponaivi ponaivi, toto, ma isi totoga latou mafai ona fanafanau ma fausia ai se vaega tele (es) taʻua o le tumo. O se tasi o ituaiga autu o lymphocytes e mafai ona tupu aʻe i le kanesa lymphomas o le tino lava B-lymphocytes (B-sela).

Bruton Tyrosine Kinase (BTK) o se mole mole o le B-cell antigen receptor ma cytokine receptor ala. O ia faailo BTK mafua ai le faʻagaoioia o ala talafeagai mo le faʻateleina o sela B, fefaatauaiga, chemotaxis, ma pipiʻi.

O le Acalabrutinib o se laʻititi o poloka poloka o le BTK. Uma acalabrutinib ma lona galue metabolite, ACP-5862, gaioiga e fausia ai se fesoʻotaʻiga fesoʻotaʻiga ma le totoe o le cysteine ​​(Cys481) i le BTK 'upega tafaʻilagi, e mafua ai le taofiofia o le BTK enzymatic gaioiga. faailo polotini CD86 ma CD69, lea e iʻu ai ona taofia le faʻamaʻi B-cell faʻateleina ma ola.

O le ibrutinib e masani ona amanaʻia o le muamua-i-le vasega BTK taofi, o le acalabrutinib e avea o le lona lua augatupulaga BTK taofi muamua ona o loʻo faʻaalia ai le maualuga o le filifilia ma le taofiofia o le faʻatinoina gaioiga a le BTK a o le i ai o se sili atu IC50 pe a le o toeititi lava leai se taofi i luga o le gaoioiga kinase a ITK, EGFR, ERBB2, ERBB4, JAK3, BLK, FGR, FYN, HCK, LCK, LYN, SRC, ma le YES1.

I lona faʻataʻitaʻiga, o le acalabrutinib na fuafua lelei ina ia sili atu lona malosi ma filifili nai lo le ibrutinib, i taimi uma e faʻaalia ai le laʻititi o aʻafiaga leaga - i le talitonuga - ona o le vailaʻau ua faʻaitiitia ai le faʻamoemoe o aafiaga.

AASraw o le polofesa gaosi oloa o Acalabrutinib.

Faʻamolemole kiliki ii mo upusii faʻamatalaga: Faʻafesoʻotaʻi matou

 

O a ni aʻafiaga e ono tutupu i le Acalabrutinib?

Acalabrutinib ono mafua ai aʻafiaga matuia, aofia ai:

O faʻamaʻi pipisi e mafai ona tupu i le taimi o togafitiga ma Acalabrutinib ma ono iʻu ai i le oti. E mafai e lau fomaʻi tausi soifua ona faʻatonuina ni vailaʻau pe a fai o oe ua sili atu le ono maua i siama. Taʻu vave i lau fomaʻi soifua maloloina pe a iai sau faʻailoga poʻo ni faʻailoga o se faʻamaʻi, e aofia ai le fiva, malulu, poʻo faʻamaʻi fulū-pei o le flu.

O faʻamaʻi toto (hemorrhage) e mafai ona tupu i le taimi o togafitiga ma Acalabrutinib ma e ogaoga ma ono iʻu ai i le oti. E ono faʻateleina lou ono maua i le palapala pe afai o loʻo e inuina se vailaʻau manifinifi ile toto. Taʻu i lau fomaʻi soifua maloloina pe a iai ni faʻailoga poʻo ni faʻailoga o le palapala toto, e aofia ai le toto i ou faʻataʻavale poʻo ni nofoa uliuli (foliga mai o le tar), piniki poʻo le enaena mimi, faʻatali totoina poʻo le palapala toto e ogaoga pe e te le mafai faʻatonutonu, puaʻi le toto pe puaʻi ia foliga mai o kofe kuka, tale i le toto poʻo le faʻaputuga toto, niniva, vaivai, le mautonu, suiga i lau tautala, tiga le ulu e umi se taimi, pe faʻapipiʻi pe mumu poʻo paʻu faailoga paʻu

Faʻaitiitia i le toto sela faitauga. O le paʻu o le toto (o sela papaʻe o sela, papamaa, ma sela mumu o le toto) e taatele i le Acalabrutinib, ae mafai foi ona ogaoga. E tatau i lau fomaʻi soifua maloloina ona faia suʻesuʻega toto e siaki ai lou toto i taimi uma o togafitiga ma Acalabrutinib.

Kanesa tulaga lua lona lua. O kanesa fou na tupu i tagata i taimi o togafitiga ma Acalabrutinib, e aofia ai kanesa o le paʻu poʻo isi totoga. O lau fomaʻi soifua maloloina o le a siaki oe mo paʻu kanesa i taimi o togafitiga ma Acalabrutinib. Faʻaaoga le puipuiga o le la pe a e i fafo i le susulu o le la.

O le fatu fatu faʻafitauli (atrial fibrillation ma atrial flutter) na tupu i tagata togafitia ma Acalabrutinib. Taʻu i lau fomaʻi tausi soifua pe a iai ni faʻailoga poʻo ni faʻailoga o loʻo mulimuli mai: vave pe le faʻasolosolo le tata o le fatu, niniva, lagona faʻavaivai, lagona le lelei o le fatafata, poʻo le manava lava

O aʻafiaga masani a le Acalabrutinib e aofia ai le tiga o le ulu, manava manava, muso ma soʻoga soʻoga, pito i luga o faʻamaʻi manava auala, ma le papala.

E le o mea uma na ono mafai ona tupu mai i le Acalabrutinib. Valaʻau lau fomaʻi mo fautuaga faʻafomaʻi e uiga i aʻafiaga. E mafai ona e lipotia ni aʻafiaga i le FDA i le 1-800-FDA-1088.

 

Acalabrutinib

 

 

Acalabrutinib VS Ibrutinib

O le BTK e taua tele i le B-cell receptor signaling ala; O le acalabrutinib e fusifusia faʻafuaseʻi i le BTK ma taofia ai lona gaioiga. O le vailaʻau na fuafuaina e avea o se ono sili filifiliga a le BTK taofi, i se taumafaiga e faʻaitiitia nisi o togafitiga-faʻatapulaʻaina oona e masani ona vaʻaia ma ibrutinib. Faʻailoa e Dr. Brown, "O le Acalabrutinib o le BTK e taofia le filifilia o filifiliga mo tagata e maua i le gasegase, aemaise ai lava mea tau fatu."

O faʻamatalaga aoga e foliga tutusa i le va o le acalabrutinib ma le ibrutinib, e ui lava o le tulitatao e umi atu ma ibrutinib, na faʻaauau pea Dr. Brown. O le mea lea, o le autu eseʻesega i le va o vailaʻau o loʻo taʻoto io latou itu-aafiaga faʻamaumauga. O Ibrutinib e masani ona sili atu ona le taliaina i tagata matutua ma e fesoʻotaʻi ma maualuga maualuga o le atrial fibrillation ma le toto maualuga. "O le Acalabrutinib e sili atu lona taliaina-nai lo le ibrutinib], o lea ou te faʻaaogaina sili ai, ae maise lava i oʻu tagata matutua gasegase," o lana tala lea.

O le faʻamaonia o le vailaʻau i le CLL, na faʻatagaina ia Novema 2019, na faʻavae i luga o le saogalemu ma le aoga faʻamaumauga mai taimi le tumau o suʻesuʻega o le ELVATE-TN faʻataʻitaʻi o tagata mamaʻi ma CLL muamua na le togafitia ma le ASCEND faʻataʻitaʻi o tagata mamaʻi na toe faʻasolosolo pe toe ola CLL na faʻaalia le sili atu o le alualu i luma-leai se ola faʻatusatusa i le faʻataʻitaʻiga togafitiga, ma se alofagia faʻapalepale talaaga otooto. I le faʻataʻitaʻiga o le ELEVATE-TN, faʻapitoa lava, o le acalabrutinib faʻatasi ma le obinutuzumab ma e pei o le monotherapy na faʻaititia ai le ono aʻafia o faʻamaʻi poʻo le maliu e le 90% ma le 80%.

"Tolerability tumau pea o se mataupu i le taimi nei togafitiga laufanua o le CLL, lea e ono manaʻomia faifai pea togafitiga mo le tele o tausaga," Faʻailoa Jeff Sharman, MD, Faatonu o Suesuega i Willamette Valley kanesa Institute, Medical Director of Hematology Research mo The US Oncology Network, ma o le taʻitaʻi tusitala o le faamasinoga o le ELEVATE-TN, i se pepa o faamatalaga. "I le ELVATE-TN ma ASCEND faʻataʻitaʻiga faʻatusatusa le [acalabrutinib] i le masani ona faʻaaoga togafitiga, [acalabrutinib] faʻaalia ai se falemaʻi aoga aoga i le alualu i luma-leai se ola i tagata mamaʻi i le tele o nofoaga, ae o loʻo tumau lona alualu i luma taliaina ma le saogalemu talaaga."

 

Suesuega: Acalabrutinib I Togafitiga Leukemia lymphocytic taimi (CLL)  

(1) Leukemia lymphocytic taimi (CLL)

Leukemia o le lymphocytic taimi (CLL), o le leukemia matutua masani, o le clonal neoplasm e aofia ai monomorphic laiti matutua B sela e coexpress CD5 ma CD23. O le laufanua o togafitiga o CLL na suia tele i tausaga talu ai nei. Fualaʻau faʻatatau i polotini i le B cell antigen receptor (BCR) auala, pei o ibrutinib, ua faʻaalia le alualu i luma i le alualu i luma saoloto ma le aotelega ola, e aofia ai i tagata mamaʻi ma maualuga-lamatiaga faʻamaʻi. E ui lava o nei vailaʻau ua toe suia le faʻataʻitaʻiga togafitiga i tagata mamaʻi ma CLL, togafitiga faʻailoaina ma malosi ma ibrutinib mafai ona faʻatapulaʻaina ona o le itu-aafiaga faʻamatalaga ma togafitiga-fesoʻotaʻei oona. O le Acalabrutinib, o le lona lua o augatupulaga ma sili atu ona filifilia le tyrosine kinase (BTK) a Bruton, na atiaʻe e faʻateleina ai le aoga a o faʻaitiitia ai le leaga o le faʻafitauli na mafua mai i le ibrutinib, na avea ma tulaga lua o le ibrutinib's off-target effects. O lenei iloiloga o le a aoteleina ai le atinaʻe, muamua-falemaʻi iloiloga, ma autu faʻataʻitaʻi falemaʻi na faʻaalia ai le aoga o le acalabrutinib ma le faʻamaonia oona i CLL.

 

(2) Suʻesuʻega Preclinical o Acalabrutinib i CLL

O le tele o faʻataʻitaʻiga suʻesuʻega na faʻaalia ai le aoga o le acalabrutinib i le BTK taofi. Pe a faʻataʻitaʻia le toto atoa o le tagata, o le acalabrutinib na faʻaauupegaina i le BTK peʻa faʻatusatusa i le ibrutinib. Na maua Ibrutinib e mafua ai le faʻateleina apoptosis o sela CLL pe a faʻatusatusa i le acalabrutinib, lea e mafai ona faʻamatalaina e ala i le faʻamoemoega o ibrutinib. O le Acalabrutinib e itiiti sona aoga i sela soifua maloloina T ona o lona filifilia e faʻatusatusa i le ibrutinib.

O aʻafiaga anti-tumal o le acalabrutinib na iloiloina i ni ata faʻapitoa e lua o le murine CLL: o se TCL1 vaetamaina faʻataʻitaʻiga se faʻataʻitaʻiga ma se tagata ua faʻaaogaina le CLL. O le Acalabrutinib na faʻaalia e taofi ai le faʻailo a le BCR ma togafitiga ma le acalabrutinib, na fesoʻotaʻi ma le taua tele o le ola pe a faʻatusatusa i isumu e leʻi togafitia (median 81 aso vs 59 aso, p = 0.02). Acalabrutinib na mafua ai foi le taua faʻaititia o sela faʻateleina ma le aofaʻi atoa avega mamafa i le alatoto.

O le fesoʻotaʻiga a Acalabrutinib ma anti-CD20 monoclonal antibodies ua uma foi ona iloiloina. E mafai ona faʻalavelaveina e Ibrutinib le tele o metotia o gaioiga a le anti-CD20 antibodies e taofia ai le puipuia o le tino i le cytotoxicity ma le phagocytosis e ono faʻaititia ai a latou anti-tumo. ma maua ai e leʻi faʻalavelaveina i nei gaioiga, ono mafua mai i le laʻititi o taunuʻuga o le acalabrutinib. E ui lava o le tuʻufaʻatasia o le acalabrutinib ma le anti-CD20 monoclonal antibody e leʻi suʻesuʻeina i se in vivo faʻataʻitaʻiga, tele vaega 2 ma vaega 3 suʻesuʻega o loʻo faʻaauau pe ua maeʻa foʻi e faʻaalia ai le aoga o le acalabrutinib i le tuʻufaʻatasia ma le anti-CD20 monoclonal antibody.

O isi acalabrutinib tuufaatasiga na suʻesuʻeina uma i vitro ma in vivo models. Acalabrutinib na tuʻufaʻatasia ma le PI3Kdelta inhibitor (ACP-319) i le murine CLL faʻataʻitaʻiga ma faʻaalia ai le sili atu faʻaititia o tuma faʻateleina, NF-KB faʻailo ma faʻaaliga o BCL-xL ma MCL-1 pe a faʻatusatusa i le monotherapy. e leʻi lesitalaina ile faʻataʻitaʻi o le falemaʻi na togafitia ile acalabrutinib ma le venetoclax. O lenei tuʻufaʻatasia na faʻaalia e faʻateleina le apoptosis pe a faʻatusatusa i se tasi fualaʻau, o loʻo fautua mai ai e iai se fesoʻotaʻiga faʻa-synergistic e pei ona vaʻaia ma ibrutinib ma venetoclax. O se faʻataʻitaʻiga i totonu o le vivo faʻataʻitaʻiga na faʻaalia ai le umi o le ola o isumu na togafitia ma uma acalabrutinib ma venetoclax pe a faʻatusatusa i se tasi fualaʻau.

 

(3) faaiuga

I le aotelega, o suʻesuʻega faʻamatalaina faʻaalia ai o le acalabrutinib e taua tele i togafitiga o CLL, uma togafitiga naif ma toe faʻafouina refactory. E le o mautinoa pe o le aoga e tutusa pe sili atu nai lo ibrutinib ma o loʻo faʻaauau pea suʻesuʻega i se taumafaiga e toe faʻatusatusa nei sooupu. E ui lava o vailaʻau masani a le BTK-e faʻatatau i le toto poʻo le atrial fibrillation, e seasea tupu, acalabrutinib e i ai se tulaga ese AE faʻamaumauga, aemaise lava le tiga o le ulu, lea e manaʻomia ai le faʻaeteete ma le faʻaeteete i le pulega. O faʻamatalaga mai suʻesuʻega faifai pea e iloiloina ai tuʻufaʻatasia ma le acalabrutinib o le a fesoasoani e faʻamalamalama atili ai lana matafaioi i le puleaina o le CLL. I le iuga, faatasi ai ma le faʻamaonia a le FDA, o mea moni i le lalolagi ma le acalabrutinib o le a fesoasoani e faʻamalamalama atili ai le faʻamatalaga oona.

AASraw o le polofesa gaosi oloa o Acalabrutinib.

Faʻamolemole kiliki ii mo upusii faʻamatalaga: Faʻafesoʻotaʻi matou

 

Tusitaiala

[1] US Taumafa ma Vailaau Faʻafoeina. Polokalama Orbis: Ua faʻamaonia e le FDA le acalabrutinib mo le CLL ma le SLL. Avanoa i https://www.fda.gov/drugs/resource-information-approved-drugs/project-orbis-fda-approves-acalabrutinib-cll-and-sll. Avanoa ia Aperila 29, 2020.

[2] Sharman JP, Banerji V, Fogliatto LM, et al. ELEVATE-TN: Vaega 3 suʻesuʻega o le acalabrutinib tuʻufaʻatasia ma le obinutuzumab pe toʻatasi vs obinutuzumab faʻatasi ai ma le chlorambucil i tagata mamaʻi ma leukemia masani o le lymphocytic. Toto 2019; 134 (supa 1): 31.

[3] Faʻalauiloa a le AstraZeneca Press. Faʻamaonia le filemu i le US mo tagata matutua tagata mamaʻi ma le maua i le kanesa o le lymphocytic. Avanoa i https://www.astrazeneca.com/media-centre/press-releases/2019/calquence-approved-in-the-us-for-adult-patients-with-chronic-lymphocytic-leukaemia-21112019.html. Avanoa ia Aperila 29, 2020.

[4] Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil i tagata mamaʻi ma CLL ma tuʻufaʻatasi tulaga. N Engl J Med. 2014; 370 (12): 1101–1110. faia: 10.1056 / NEJMoa1313984.

[5] Parikh SA, Manytar E, Laplant B, et al. O se faʻatusatusaga vaega 2 suʻesuʻega faʻatusatusaina acalabrutinib ma pe leai obinutuzumab i le togafitia o le vave laasaga tulaga maualuga gasegase ma Chronic Lymphocytic Leukemia (CLL) poʻo Laititi Lymphocytic Lymphoma (SLL). Toto. 2019; 134 (Faʻaopoopoga_1): 4306. faia: 10.1182 / toto-2019-123824.

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