CStone Cov Tshuaj Avapritinib tau suav nrog hauv kev tshuaj xyuas ua ntej los ntawm Lub Xeev Lub Chaw Tswj Khoom Noj thiab Tshuaj!

Tsis ntev los no, Lub Chaw Tshuaj Ntsuam Xyuas Tshuaj (CDE) ntawm National Medical Products Administration (NMPA) ntawm Tuam Tshoj suav nrog CStone' s anticancer tshuaj avapritinib tshuaj tshiab rau kev tshuaj xyuas ua ntej.

Avapritinib yog KIT / PDGFRA kinase inhibitor tsim los ntawm Blueprint Tshuaj. Nws tau pom zoo los ntawm Asmeskas FDA hauv Lub Ib Hlis xyoo no. Nws tau muag hauv lub lag luam npe Ayvakit rau kev kho mob platelet-derived kev loj hlob qhov teeb meem receptor alpha (PDGFRA) noob txiv neej.

Ayvakit yog thawj qhov kev npliag rau kev pom zoo rau kev kho mob ntawm cov neeg mob nrog GIST txhais los ntawm genome, thiab thawj qhov kev kho mob siab rau GIST nrog PDGFRA exon 18 hloov. Nws yog tsim nyog sau cia tias thaum Lub Tsib Hlis xyoo no, FDA tau muab tsab ntawv teb tiav (CRL) rau lwm daim ntawv thov tshuaj tshiab rau avapritinib, tsis kam lees pom txoj kev kho plaub rau GIST cov cim.

CStone Cov Lag Luam Nkag Mus Txog kev sib koom tes tshwj xeeb thiab kev pom zoo nrog Blueprint Tshuaj thaum Lub Rau Hli 2018, thiab tau txais kev txhim kho thiab kev ua lag luam ntawm peb tus neeg sib tw ua yeeb tshuaj suav nrog Ayvakit (avapritinib) hauv Greater China (Mainland, Hong Kong, Macau, Taiwan) txoj cai.

Tsuas yog peb lub hlis tom qab avapritinib tau pom zoo los ntawm Asmeskas FDA rau kev tshaj tawm, CStone Pharmaceuticals tau xa cov ntawv thov kev lag luam tshuaj tshiab rau avapritinib hauv Taiwan thiab Suav. Lub Plaub Hlis xyoo no, NMPA tau lees txais yuav ib daim ntawv thov tshuaj tshiab rau avapritinib, npog 2 qhov taw qhia, uas yog: (1) Rau kev kho mob ntawm cov neeg mob nqa platelet-derived kev loj hlob tau txais alpha (PDGFRA) exon 18 hloov pauv (suav nrog PDGFRA D842V kev hloov pauv) Neeg laus cov neeg mob nrog phais mob rov phais lossis metastatic GIST; (2) Cov neeg laus nrog cov plaub-kab tsis tuaj yeem pom lossis metastatic GIST.

Muaj kwv yees li 1-1.5 / 100,000 (14,000-21,000) tus neeg Gist mob tshiab hauv Suav teb txhua xyoo. Kwv yees 90% ntawm cov neeg mob GIST yog tshwm sim los ntawm KIT lossis PDGFRA noob hloov zuj zus. Kev tshawb fawb NAVIGATOR tshaj tawm pom tias avapritinib muaj qhov lus teb tag nrho (ORR) ntawm 86% hauv cov neeg mob uas muaj GIST siab heev nrog PDGFRA exon 18 hloov (suav nrog D842V kev hloov pauv), thiab ib qho ORR ntawm 22% hauv plaub-kab GIST cov neeg mob.

Hais txog GIST, nws tshwj xeeb tshaj yog tias hauv lub Tsib Hlis xyoo no, Zai Lab' tus khub Deciphera' s broad-spectrum KIT thiab PDGFRα kinase inhibitor Qinlock (ripretinib) tau pom zoo los ntawm Asmeskas FDA rau plaub-kab kev kho mob ntawm GIST siab heev. Cov. Thaum Lub Rau Hli 2019, Zai Lab thiab Deciphera tau kos npe pom zoo kom tau txais daim ntawv tso cai tshwj xeeb rau kev nthuav dav thiab Qinlock hauv Greater Tuam Tshoj (Mainland, Hong Kong, Macau, Taiwan).

Qinlock yog thawj lub tshuaj tshiab raug pom zoo rau kev kho plaub ntawm GIST. Tus qauv yog qhov tseem ceeb tshaj plaws. Cov tshuaj yog qhov tsim nyog rau: kev kho yav dhau los nrog 3 lossis ntau dua kinase inhibitors (suav nrog imatinib, sunitinib, regorafenib) Cov neeg laus uas muaj GIST.

Nyob rau hauv Suav teb, NMPA tau lees txais ib daim ntawv thov kev lag luam tshuaj tshiab rau ripretinib thaum Lub Xya Hli xyoo no rau kev kho mob rau txoj kev kho mob siab kawg uas tau kho nrog 3 lossis ntau dua kinase inhibitors suav nrog imatinib Cov neeg laus mob qog stromal hlav (GIST).

Cov ntaub ntawv los ntawm Theem III INVICTUS txoj kev sim tau pom tias piv nrog cov placebo pab pawg, qhov kev vam meej-tsis muaj sia nyob ntawm pawg neeg kho mob ripretinib tau siv sijhawm ntev (cov tshuaj nruab nrab PFS: 6.3 lub hlis piv rau. txo los ntawm 85% (HR=0.15, p< 0.0001).="" nyob="" rau="" hauv="" cov="" ntsiab="" lus="" ntawm="" cov="" theem="" ob="" kawg="" tag="" nrho="" cov="" muaj="" sia="" nyob="" (os),="" kev="" kho="" mob="" ripretinib="" pawg="" tau="" ntev="" dua="" cov="" pawg="" placebo="" (nruab="" nrab="" os:="" 15.1="" lub="" hlis="" vs="" 6.6="" lub="" hlis),="" thiab="" kev="" pheej="" hmoo="" ntawm="" kev="" tuag="" tau="" txo="" los="" ntawm="" 64%="" (hr="0.36," nominal="" p.="0.0004);" nws="" yog="" tsim="" nyog="" sau="" cia="" tias="" cov="" ntaub="" ntawv="" os="" hauv="" cov="" pawg="" placebo="" suav="" nrog="" cov="" ntaub="" ntawv="" ntawm="" cov="" neeg="" mob="" uas="" tau="" hloov="" mus="" rau="" ripretinib="" tom="" qab="" tau="" txais="" cov="" tshuaj="" placebo.="" nyob="" rau="" hauv="" cov="" nqe="" lus="" ntawm="" tag="" nrho="" cov="" lus="" teb="" feem="" ntau="" (orr)="" ntawm="" lwm="" theem="" nrab="" kawg,="" lub="" ripretinib="" kho="" pab="" pawg="" tau="" zoo="" dua="" piv="" nrog="" cov="" placebo="" pab="" pawg="" (orr:="" 9.4%="" vs="" 0%,="" p="">