AstraZeneca / Mercapto Lynparza tau txais kev pom zoo los ntawm EU: thawj txoj kab ke saib xyuas kev kho mob gBRCAm kab mob qog noj ntshav!

AstraZeneca thiab Merck& Co tsis ntev los no tshaj tawm tias European Commission (EC) tau pom zoo lub hom phiaj tshuaj anticancer Lynparza (cov npe nrov npe: olaparib) rau kev hloov pauv ntawm kev ua me nyuam BRCA kev hloov pauv (gBRCAm) Thawj kab kev saib xyuas kev kho mob ntawm cov neeg mob qog ntshav tua kabmob tshwj xeeb: cov neeg laus laus nrog metastatic mob qog noj ntshav uas tsis tau loj hlob tom qab tau txais cov tshuaj platinum-plob rau yam tsawg 16 lub lis piam ntawm thawj kev kho tshuaj tua kab mob thiab coj tus kab mob BRCA1 / 2 hloov.

Nws tsim nyog teev tias Lynparza yog tib tus PARP inhibitor pom zoo rau kev kho mob gBRCAm metastatic pancreatic cancer. Hauv Tebchaws Meskas, Lynparza tau txais kev pom zoo los ntawm FDA thaum lub Kaum Ob Hlis 2019 rau thawj kab kev saib xyuas kev kho mob rau cov neeg mob gBRCAm metastatic pancreatic cancer. Ntxiv rau Tebchaws Meskas, European Union thiab ntau lwm lub tebchaws, Lynparza' s txoj cai kev tshuaj xyuas nyob rau lwm txoj cai tseem niaj hnub ua ntxiv.

Lynparza yog lub ntiaj teb' s thawj PARP inhibitor uas tuaj yeem siv los kho plaub hom mob cancer, suav nrog: kheesxaws ntawm zes qe menyuam, mob cancer mis, mob qog ntshav, thiab mob qog nqaij hlav prostate. Cov tshuaj yog ib tug neeg xub thawj, qhov ncauj poly ADP ribose polymerase (PARP) inhibitor. Nws tau txais kev pom zoo rau 7 kev kho mob, ntawm cov 4 yog kev mob kheesxaws ntawm zes qe menyuam thiab 2 yog thawj cov kab kev saib xyuas kev kho mob rau poj niam zes qe menyuam. Tshwj xeeb: (1) thawj cov kab saib xyuas kev kho mob rau cov neeg laus cov neeg mob qog nqaij hlav cancer ntawm BRCAm; (2) ua ke nrog bevacizumab thawj-kab kev saib xyuas kev kho ntawm homologous recombination kho mob (HRD) zoo siab tshaj cov neeg mob qog nqaij hlav cancer neeg laus; (3) tswj kev kho mob rau kev mob kheesxaws ntawm zes qe menyuam Cov neeg laus coob; (4) Cov neeg mob loj hauv cov neeg muaj mob gBRCAm qog ntawm zes qe menyuam; (5) Kev kho mob rau cov neeg mob laus uas muaj gBRCAm thiab HER2-tsis zoo (HER2-) metastatic cancer mis; (6) Kho thawj txoj kab rau kev kho mob rau cov neeg laus uas muaj gBRCAm metastatic pancreatic cancer; (7) Kev Kho Mob Tom qab tau txais kev kho qog tshiab, tus neeg mob' s tus mob loj zuj zus, nqa homologous rov qab kho cov noob hloov pauv (HRRm), metastatic castration-resistant prostate cancer (mCRPC) cov neeg mob.

Qhov kev pom zoo kawg no tau ua raws li kev soj ntsuam ntawm Theem III POLO mus sib hais. Cov ntaub ntawv muaj feem xyuam tau tshaj tawm nyob rau hauv" New England Journal of Medicine" (NEJM). Qhov kev sim siab pom tias Lynparza, raws li thawj txoj kev saib xyuas kev kho mob, ze li ntawm ob zaug kev vam meej tsis muaj sia nyob ntawm gBRCAm metastatic pancreatic mob qog nqaij hlav (nruab nrab PFS: 7.4 lub hlis vs 3.8 lub hlis) piv nrog cov placebo. Los sis txoj kev pheej hmoo ntawm kev tuag tau txo qis txog 47%. Hauv qhov kev sim no, Lynparza' s kev nyab xeeb thiab thev taus nws tau ua raws li cov kev sim dhau los.

Hedy L. Kindler, tus thawj xib fwb soj ntsuam ntawm POLO kev tshawb fawb thiab tus xibfwb ntawm cov tshuaj hauv University of Chicago, hais tias:" Hnub no kev pom zoo qhib lub qhov rooj los muab kev saib xyuas biomarker rau cov neeg mob uas muaj mob qog nqaij hlav cancer rau hauv European Union, uas yog ntiaj teb mob qog nqaij hlav cancer Thaj chaw muaj qhov xwm txheej ntau tshaj plaws. Lynparza tam sim no muab cov kws kho mob nrog lub hom phiaj kev kho mob kom zoo rau kev kho mob ntawm cov leeg nqaij hlav nrog lub ntsws tawg BRCA."

Dave Fredrickson, tus lwm thawj coj ntawm AstraZeneca's oncology kev lag luam, tau hais tias: "Kev mob qog nqaij hlav yog mob txaus ntshai thiab tau kho tsis tau muaj tsawg xyoo dhau los nyob rau ntau xyoo. Hauv qhov kev sim POLO, cov neeg mob gBRCAm pancreatic mob cancer tom qab thawj cov tshuaj tua kab mob tau txais Lynparza Qhov nruab nrab tsis muaj kev muaj sia nyob (PFS) ntawm kev kho mob yuav luag ob npaug ntawm cov placebo. Kev pom zoo no qhia txog qhov tseem ceeb ntawm kev sim kab mob BRCAm ntawm txhua tus neeg mob thaum lub sijhawm kuaj mob, vim qhov no yuav pab cov tib neeg nrog cov neeg mob EU kev kho mob."

Pancreatic cancer yog mob cancer tuag nrog mob siab heev li tsis xav tau kev kho mob. Kev mob kheesxaws Pancreatic yog hom mob cancer 11 uas yog ntau tshaj thiab yog xya tus kabmob uas ua rau mob cancer tuag rau ntiaj teb. Tus muaj sia nyob feem ntau ntawm cov qog nqaij hlav feem ntau yog qhov phem tshaj. Hauv txhua lub tebchaws, 5-lub xyoo muaj sia nyob tom qab kev kuaj mob tsuas yog ib tus lej (2- 9%). Kev paub thaum ntxov ntawm kev mob kheesxaws pancreatic yog qhov nyuaj. Cov neeg mob feem ntau asymptomatic, thiab cov tsos mob tsis tshwm kom txog thaum tus kab mob mus txog rau theem kawg. Li ntawm 80% ntawm cov neeg mob tau kuaj mob hauv theem metastatic, thiab lub sijhawm nruab nrab ntawm cov neeg mob no tsawg dua li ib xyoos.

Hauv ob peb lub xyoos dhau los, muaj kev txhim kho me ntsis hauv kev kuaj mob thiab kho tus mob cancer pancreatic. Cov kev kho tam sim no feem ntau yog kev phais mob (tsuas yog rau 10-20% ntawm cov neeg mob), kev siv tshuaj kho mob thiab kho hluav taws xob, qhia lub ntsiab tsis tseem ceeb rau cov kev xaiv ua kom muaj txiaj ntsig zoo dua. Thoob plaws ntiaj teb, kwv yees li 460,000 tus neeg mob tshiab tau tshawb pom hauv xyoo 2018, thiab gBRCAm tus kabmob kheesxaws hauv lub cev yog 5-7% ntawm txhua kis.

Lynparza (Lipuzhuo): tau teev tseg rau hauv Suav Tebchaws, thiab tau suav nrog Daim Ntawv Pov Hwm Kev Pov Hwm Kev Lag Luam Hauv Tebchaws

Lynparza tau pom zoo los ntawm Asmeskas FDA rau thaum Lub Kaum Ob Hlis 2014 thiab tau dhau los ua tus thawj hauv ntiaj teb pom zoo PARP inhibitor. Lynparza yog qhov kev pib ua haujlwm, qhov ncauj PARP inhibitor uas siv cov tsis xws luag hauv DNA kho txoj hauv kev los nyiam qhov tua cov qog noj ntshav. Cov hom kev ua no muab Lynparza lub peev xwm kho tau ntau yam hlav uas muaj peev xwm tsis xws luag nyob rau hauv kev kho DNA. PARP muaj feem xyuam nrog ntau ntawm cov qog ntshav, tshwj xeeb yog mob cancer ntawm lub mis thiab zes qe menyuam.

Thaum Lub Xya Hli 2017, AstraZeneca thiab Merck tau mus txog thoob ntiaj teb kev koom tes hauv oncology los tsim kev lag luam thiab kev ua lag luam Lynparza thiab lwm qhov MEK inhibitor, selumetinib, los kho cov qog ntau, xws li mob cancer mis, mob qog nqaij hlav cancer, thiab mob qog nqaij hlav cancer.

Nyob rau hauv Suav lag luam, Lynparza tau pom zoo los ntawm Tuam Tshoj National Drug Administration (CNDA) rau Lub Yim Hli 23, 2018 rau kev saib xyuas kev kho mob ntawm platinum-rhiab kev mob kheesxaws ntawm zes qe menyuam. Qhov kev pom zoo no ua rau Lynparza yog thawj lub hom phiaj tshuaj pom zoo rau kev kho mob qog ntawm zes qe menyuam hauv Suav lag luam, kos cim nkag teb chaws Suav' s kev kho mob cancer ntawm zes qe menyuam mus rau lub sijhawm ntawm PARP inhibitors.

Thaum lub Kaum Ob Hlis 2019, Lynparza tau pom zoo dua thawj zaug kev kho mob thib ib ntawm cov neeg mob uas muaj tus mob BRCA-mutated paub ntau tshaj ntawm zes qe menyuam. Tau txais txiaj ntsig Suav Tuam Tshoj' s muaj zog ua haujlwm pab txhawb rau kev tsim kho tshuaj tshiab thiab ua kom muaj kev xav tau sai sai rau cov tshuaj pom zoo tshiab hauv kev sim tshuaj, Lynparza tau dhau los ua Tuam Tshoj' s thawj pom zoo PARP inhibitor rau thawj kab kev kho kev kho mob ntawm zes qe menyuam. Thaum Lub Kaum Ib Hlis 28, 2019, Lynparza tau muaj nyob hauv Phau Ntawv Qhia Nyiaj Pov Hwm Kev Mob Nkeeg Hauv Tebchaws.