Mushonga mutsva wekushandisa kurapwa kwegomarara rethyroid

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rakanyorwa Linda Hohnholz

CSstone Pharmaceuticals nhasi yazivisa kuti National Medical Products Administration (NMPA) yekuChina yabvumidza imwe yekuwedzera mushonga mutsva (sNDA) yekusarudza RET inhibitor GAVRETO® (pralsetinib) yekurapa RET-mutant medullary thyroid cancer (MTC) uye RET fusion. -positive thyroid cancer (TC). Mvumo iyi yakawedzera zviratidzo zvakanyorwa zveGAVRETO kuChina kuti zvibatanidze varwere vakuru nevana vane makore gumi nemaviri zvichikwira vane advanced or metastatic RET-mutant MTC inoda systemic therapy, uye varwere vevakuru nevana vane makore gumi nemaviri zvichikwira vane metastatic kana metastatic. RET fusion-positive TC inoda systemic therapy uye radioactive iodine-refractory (kana radioactive iodine kurapwa kwakakodzera).

Yakawanikwa nemumwe weCSstone Blueprint Medicines, GAVRETO ine simba uye inosarudza RET inhibitor. Cstone ine chibvumirano chakasarudzika uye rezinesi chibvumirano neBlueprint Mishonga yekusimudzira uye kutengeserana kweGAVRETO muGreater China, iyo inosanganisira Mainland China, Hong Kong, Macau neTaiwan.

Dr. Frank Jiang, Sachigaro uye CEO weCSstone, vakati, "Tinofara zvikuru nemvumo yeSNDA yeGAVRETO, iyo ichapa nzira itsva yekurapa kuvarwere vekuChina vane chirwere chepamusoro cheRET-mutant medullary thyroid cancer uye RET fusion-positive thyroid cancer. . Tinodawo kupa kutenda kwedu kuNMPA nekuongorora kwakakosha. CSstone inogara yakazvipira kugadzira marapirwo matsva ekugadzirisa izvo zvisingaite zvinodiwa zvekurapa zvevarwere vegomarara. Ticharamba tichiwedzera kukosha kwekiriniki uye kugona kwepombi yedu, uye kuwedzera nhamburiko dzekupa varwere pasi rese mishonga yemhando yepamusoro, yemhando yepamusoro. "

Muzvinafundo Ming Gao, Muongorori Mukuru weArROW kudzidza uye Mutungamiriri weTianjin Union Medical Center, akati, "Huwandu hwekenza yegomarara huri kuwedzera mumakore achangopfuura. Kune nzira shoma dzekurapa dzekiriniki dzekurapwa kweMTC, uye panodiwa nekukurumidza marapirwo echokwadi, kunyanya kuvarwere vane RET-mutant MTC. GAVRETO yakaratidza kuita kwakasimba uye kwakasimba kwekurwisa bundu muvarwere vekuChina vane advanced kana metastatic RET-mutant MTC, ine kuchengetedzeka kwese kunofambirana nemhedzisiro yakaonekwa muchidzidzo chepasi rose ARROW. Nekuwedzera uku kwezviratidzo zvakanyorwa zveGAVRETO, tinotarisira kugadzirisa zvisingaite zvinodiwa nevarwere vegomarara rethyroid.

Dr. Jason Yang, Chief Medical Officer weCSstone, vakati, “Kubvumidzwa kweNMPA kwesNDA ndechimwe chiitiko chakakosha kwatiri mushure mekunge GAVRETO yatenderwa kurapwa kwevarwere vemunharaunda yepamusoro kana metastatic RET fusion-positive isiri diki cell cancer cancer. . Tinoda kutenda varwere vese nevaongorori vakaita muongororo yekiriniki yeGAVRETO muzviratidzo zvakawedzerwa. Ticharamba tichisimudzira tsvakiridzo yekiriniki yeGAVRETO yekurapa marudzi akawanda egomarara kuitira kuti tikurumidze kuunza mushonga uyu unobatsira kubatsira varwere vakawanda. "

Mvumo yeSNDA yakavakirwa pamhedzisiro kubva muyedzo yepasi rose 1/2 ARROW, yakagadzirirwa kuongorora kuchengetedzeka, kushivirira uye kushanda kweGAVRETO muvarwere vane RET fusion-positive NSCLC, RET-mutant MTC, uye mamwe mapundu akasimba akasimba ane RET fusions. . Kubva musi waKubvumbi 12, 2021, varwere makumi maviri nevasere vane RET-mutant MTC yepamusoro vakanyoreswa muChina MTC yekunyoresa bhiridha cohort yechidzidzo chepasi rose ARROW, uye vakagamuchira yekutanga GAVRETO dose ye28mg kamwe chete pazuva. Mhedzisiro yeongororo yakaratidza kuti iyo yakasimbiswa chinangwa chekupindura mwero (ORR) ye400 RET-mutant MTC varwere vane chirwere chinoyerwa pakutanga yaive 26%, kusanganisira 73.1 nemhinduro yakakwana (CR) uye 3 ine chikamu chemhinduro (PR). Chirwere chekudzivirira chirwere (DCR) chaiva 16%, uye mhinduro dzakaonekwa pasinei neRET mutation genotype. Pakati pevarwere ve84.6 vane mhinduro yakasimbiswa, nguva yepakati yekupindura (DOR) haina kusvika, uye 19-mwedzi DOR chiyero chaiva 9%. Calcitonin uye carcinoembryonic antigen (CEA) mazinga akaderedzwa zvakanyanya. GAVRETO yaiwanzotenderwa zvakanaka, pasina masaini matsva ekuchengetedza akaonekwa. Mhedzisiro yeChina yekunyoresa bridging cohort yakaunzwa panguva yekunonoka kutyora yemuromo abstract session pa100th Annual Meeting yeAmerican Thyroid Association (ATA) 90.

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Linda Hohnholz

Editor mukuru we eTurboNews yakavakirwa muTN HQ.

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