Cstone Cov Tshuaj Muaj Tshuaj hauv ib txoj kev txhim kho, tau npaj siab kom tau txais kev pom zoo los ntawm CHMP

Blueprint Tshuaj, tus khub ntawm CStone Pharmaceuticals, tau tshaj tawm tsis ntev los no hais tias European European Medicines Agency' s Pawg Neeg Saib Xyuas Cov Khoom Siv Tshuaj rau Cov Neeg Siv (CHMP) tau tshaj tawm cov lus pom zoo hais txog kev pom zoo los ntawm kev teev npe ntawm avapritinib ntsiav tshuaj (avapritinib) raws li tshuaj mob hlwb. Txog kev kho mob ntawm qhov tsis muaj kev tiv thaiv lossis metastatic gastrointestinal stromal hlav (GIST) cov neeg laus cov neeg mob platelet-derived loj hlob receptor alpha (PDGFRA) gene exon 18 D842V hloov pauv. Cov European Commission yuav ua rau kev pom zoo zaum kawg uantej lub Cuaj Hlis xyoo no.

Apotinib yog lub zog muaj zog thiab meej meej tshwj xeeb cov KIT thiab PDGFRA mutant kinase inhibitor tsim los ntawm Blueprint Tshuaj. CStone Cov Tshuaj muaj kev tsim kho tshwj xeeb thiab kev tso cai ua lag luam yeeb tshuaj nyob rau hauv Suav Tuam Tshoj. Thaum xyoo 2020, apotinib tau pom zoo los ntawm Asmeskas FDA rau kev kho mob tsis muaj kev tiv thaiv lossis metastatic GIST cov neeg laus cov neeg mob uas muaj kev hloov pauv hauv exon 18 ntawm PDGFRA noob (suav nrog PDGFRA D842V hloov). Nws yog thawj thawj cov GIST raug tsom ntsoov rau kev lag luam hauv Tebchaws Meskas Txog Tshuaj.

CHMP' s kev soj ntsuam zoo ntawm apotinib raws li kev ua tau zoo thiab kev nyab xeeb cov ntaub ntawv ntawm NAVIGATOR Theem 1 kev sim tshuaj, thiab cov txiaj ntsig kev nyab xeeb ntawm VOYAGER Theem 3 soj ntsuam sim. Cov ntaub ntawv qhia tau hais tias apotinib tau qhia cov kev sib sib zog nqus thiab ntev ntev hauv kev kho mob hauv kev kho PDGFRA exon 18 D842V mutant GIST cov neeg mob, thiab nws tau zoo mob siab rau. Cov ntaub ntawv tshawb fawb tshawb fawb muaj feem tau tshaj tawm nyob rau hauv phau ntawv Journal The Lancet Oncology thaum Lub Rau Hli 29, 2020.

Cov lus tshuaj xyuas ntawm CHMP yuav muab xa mus rau European Commission (EC) lub luag haujlwm rau kev pom zoo kev lag luam tso cai rau cov khoom lag luam tshuaj rau kev tshuaj xyuas ntxiv. Hais txog daim ntawv thov cov npe apotinib, European Commission yuav tsum ua tiav kev pom zoo ua ntej kawg ntawm lub Cuaj Hli xyoo no. Yog tias tau txais kev pom zoo, apotinib yuav dhau los ua thawj lub hom phiaj kho tshuaj rau cov neeg mob GIST uas nqa D842V hloov pauv hauv exon 18 ntawm PDGFRA noob rau kev ua lag luam hauv European Union. Cov tshuaj muaj muag nyob hauv kev lag luam npe AYVAKYT.

Hauv Suav teb, CStone Pharmaceuticals xa cov ntawv thov tshuaj tshiab rau apotinib rau National Food thiab Drug Administration (NMPA) ntawm Tuam Tshoj lub Plaub Hlis xyoo no, hais txog ob qhov taw qhia: ① Rau kev kho mob platelet-derived kev loj hlob factor receptor alpha (PDGFRA) Exon 18 kev hloov pauv (suav nrog PDGFRA D842V kev hloov pauv) hauv cov neeg mob cov neeg laus uas tsis tuaj yeem tiv thaiv lossis mob kis GIST, thiab patients cov neeg mob laus uas muaj plaub-kab tsis paub txog lossis metastatic GIST.