UK NICE pom zoo Roche Kadcyla mob qog noj ntshav mis thaum ntxov

Lub Tsib Hlis 7, National Institute of Health thiab Health Excellence (NICE) tau tshaj tawm cov lus taw qhia pom zoo siv Roche-tsom kev tshuaj tua kab mob Kadcyla (trastuzumab emtansine) ua ib qhov kev loj hlob ntawm lub cev {{{2 }} (HER 2) txoj kev muaj mob khees xaws mis thaum ntxov yog txoj kev kho mob uas nyob ib puag ncig. Cov neeg mob uas muaj hnub nyoog lawm tseem muaj cov kab mob sib kis ntawm lub mis lossis cov qog ntshav tom qab tau txais neoadjuvant raws li kev them se-raws li kev kho mob thiab HER 2 tsom kev kho.

Lub hom phiaj ntawm kev kho mob neoadjuvant yog los txo qhov loj ntawm cov qog ua ntej kev phais mob. Tom qab tau txais kev kho mob no, qee zaum cov qog yuav vau tag nrho, tab sis tus neeg mob tseem tuaj yeem nqa cov qog nqaij hlav tom qab tau phais mob (nrog cov kab mob sib kis). Los sis, cov qog nqaij hlav cancer yuav kis mus rau cov qog ua ntshav rau lub qhov ncauj (cov mob qog ua ntshav-mob siab).

Cov kev kho kom haum pab txo qis kev mob qog nqaij hlav tom qab kev phais. NICE tau taw qhia hauv cov qauv lus pom zoo tias trastuzumab yog ib qho kev kho mob rau qhov mob rau cov neeg mob uas ua haujlwm tsis zoo los yog ua rau lub qog ntshav. Tam sim no, Pertuzumab ua ke nrog trastuzumab ntxiv rau kev siv tshuaj kho mob yog ib qho kev kho mob rau cov qog ntshav-mob cancer, tab sis nws tsis siv rau cov kab mob ntsws-mob tsis zoo. Emmetastuzumab tuaj yeem siv los ua kev kho mob rau cov neeg mob uas muaj cov leeg mob tsis zoo lossis lub qog zoo.

Trastuzumab emtansine, lub npe lag luam Kadcyla yog HER 2 - tsom tshuaj txhaj tshuaj tiv thaiv kab mob sib xyaw. Ntawm lawv, trastuzumab yog qhov tshuaj tiv thaiv cov neeg HER {{2}} IgG 1 cov tshuaj tiv thaiv, thiab cov roj me me cytotoxin DM 1 yog microtubule inhibitor. HER {{2}} yog ib qho protein nyob rau saum npoo ntawm kev mob hlwb, uas ua rau cov kabmob hlwb loj tuaj thiab faib. Tom qab khi nrog HER {{2}} receptor subdomain IV, emmetastuzumab yauv raug receptor-mediated internalization thiab tom qab lysosomal kev puas tsuaj, uas ua rau muaj kev tso tawm cytotoxic catabolite DM 1 hauv hlwb. Kev sib xyaw ua ke ntawm DM 1 thiab tubulin cuam tshuam rau lub vev xaib microtubule cuam tshuam, ua rau lub voj voog ntawm tes raug ntes thiab apoptotic cell tuag. Tsis tas li ntawd, nyob rau hauv kev tshawb fawb hauv vitro tau qhia tias, zoo ib yam li trastuzumab, emmetastuzumab inhibits HER {{{{2}} receptor signaling, mediates antibody-depend cell-mediated cytotoxicity, thiab inhibits tib neeg mob cancer ntawm lub mis uas overexpress HER {{{ {14}}}} Kev ntuav ntawm kev tso npe ntawm HER 2.

Cov ntaub ntawv pov thawj los ntawm kev kuaj mob pom tias hauv cov neeg mob uas muaj qhov mob qog nqaij hlav tom qab neoadjuvant kho thiab phais mob, piv nrog trastuzumab ib leeg, emmetastuzumab tsub kom tus neeg mob' Nws tseem tsis tau meej meej tias emmetastuzumab yuav ua kom ntev li lub sijhawm muaj sia nyob ntawm cov neeg mob vim tias kev sim zaum kawg tseem tsis tau mus txog.

Txawm li cas los xij, kev sib piv ntawm cov lymph node-positive cov neeg mob tau qhia tias piv nrog pertuzumab ua ke nrog trastuzumab ntxiv rau kev siv tshuaj kho mob, emmetastuzumab nce lub sijhawm txog thaum mob qog dua. Txawm hais tias qhov xaus no tsis tshua meej, vim tias muaj qhov sib txawv ntawm cov neeg mob hauv ob txoj kev sim. Txawm li cas los xij, NICE tau hais tom qab kev ntsuam xyuas tus nqi-txiaj ntsig tias cov tshuaj muaj peev xwm suav nrog kev siv cov peev txheej ntawm Kev Pabcuam Kev Noj Qab Haus Huv Hauv Tebchaws (NHS) hauv tebchaws Askiv, thiab yog li ntawd pom zoo kom siv emmetastuzumab.

Meindert Boysen, tus thawj coj saib xyuas haujlwm ntawm NICE thiab tus thawj coj ntawm Kev Tshawb Fawb Kev Noj Qab Haus Huv Technology Center, tau sau tseg:" Ntxiv kev xaiv kev kho mob. Yog li no, peb zoo siab yuav kom peb tuaj yeem pom zoo qhov kev kho kom zoo rau kev siv niaj hnub tom qab HER2-zoo thaum ntxov cov neeg mob cancer mis."

Hauv tebchaws Askiv, kwv yees li 7, 000 tus neeg mob qog noj ntshav mis thaum ntxov pom tias HER 2 zoo txhua xyoo. Raws li kev kwv yees kwv yees NICE, kwv yees txog 800 tib neeg tsim nyog tau txais txoj kev kho tshiab tshiab txhua xyoo.

Nws tau tshaj tawm tias emmetastuzumab yog suav nrog tus nqi tas nrho, thiab tus nqi nruab nrab ntawm ib chav kawm ntawm kev kho mob rau tus neeg mob yog 51, 000 phaus (txog 63, 100 Asmeskas las). Tab sis zoo ib yam li lwm lub tsev muag tshuaj uas tau pom zoo rau NHS kev tuav pov hwm kho mob, Roche kuj tseem yuav muab cov nqi txo kom tsis pub leej twg paub, uas yog raws daim ntawv teev nqi £ 51, 000.

Tom qab ntau tshaj plaub xyoos ntawm kev tsis pom zoo ntawm Roche thiab NICE, Kadcyla tau txais kev pom zoo rau txhua tus neeg mob HER2-zoo mob cancer mis uas tau txais kev kho mob thib ob nrog Herceptin thiab kev siv tshuaj kho mob. Lub Rau Hli 2017, NICE tau txhawb nqa Kadcyla kom npog los ntawm NHS cov pa kom tiv thaiv kom tsis txhob rov mob HER2-zoo mob cancer mis ntau dua tom qab kev kho mob tom qab. Qhov no txhais tau hais tias cov neeg mob cancer mis uas tseem muaj cov qog nyob hauv qog tom qab tau txais kev kho mob neoadjuvant nrog Roche Herceptin suav nrog kev siv tshuaj kho mob yuav siv tau Kadcyla los tiv thaiv kom tsis txhob mob ntxiv.

Thaum lub Tsib Hlis 2019, Kadcyla tau txais kev tso cai los ntawm Asmeskas FDA los nkag rau cov kev kho mob rau kev kho mob qog mis thaum ntxov, thiab tom qab ntawd tau pom zoo los ntawm European Union thiab Canada thaum kawg ntawm 2019. Cov kev pom zoo no raug txiav txim raws li kev soj ntsuam ntawm KATHERINE theem 3 kev sim tshuaj rau cov neeg mob uas muaj mob cancer mis thaum ntxov. Qhov kev sim no qhia tias Kadcyla tiv thaiv kom tsis txhob mob cancer mis hauv {{3}}. {3% ntawm cov neeg mob hauv peb lub xyoos, piv nrog rau 77% rau Herceptin%.

Roche muaj cov khoom lag luam 3 tsim tawm tshiab tsim kho rau HER 2 cov paib tseem ceeb, uas yog Herceptin, Perjeta thiab Kadcyla. Txij li cov xov xwm zoo siab" Herceptin poob tswv yim tiv thaiv" ;, Roche tau suav rau Perjeta thiab Kadcyla kom pab cov tuam txhab txuas ntxiv nws txoj kev lag luam.

Qhov kev cia siab no tau ua tiav nyob hauv thawj peb lub hlis xyoo no. Kev muag ntawm ob lub tshuaj tau mus txog 1. 01 billion Swiss francs (txog 1. 04 nphom US $) thiab 428 lab Swiss francs (txog { {5}} lab lab daus las), uas tshaj li Herceptin-Sales nyob rau thawj peb lub hlis yog CHF 1. 21 nphom (kwv yees USD {{0}. 25 nphom), a 1 2% tsawg dua los ntawm tib lub sijhawm ntawm xyoo tas los.

Tab sis tam sim no, Roche' s HER 2 ntawm cov tshuaj tseem tab tom ntsib cov kev tawm tsam tshiab muaj zog, uas yog, tshuaj tiv thaiv tshuaj tiv thaiv Enhertu ua ke tsim los ntawm AstraZeneca thiab Daiichi Sankyo. Txawm hais tias tam sim no Enhertu tsuas yog tso cai rau cov neeg mob cancer mis uas tsis ua tiav ob txoj hauv kev kho mob, cov kws tshawb nrhiav tau ua ib lub taub hau, ib qho kev tshawb nrhiav ncaj qha tshuaj thiab Kadcyla kho mob thib ob los sim ua pov thawj superiority ntawm Enhertu. Nws tau tshaj tawm tias Enhertu' kev muag khoom tau txog US $ 30 lab hauv thawj peb lub hlis xyoo no.