Ukusetyenziswa kwechiza esitsha kunyango lomhlaza wegilo

I-CSstone Pharmaceuticals namhlanje ibhengeze ukuba i-National Medical Products Administration (NMPA) yaseTshayina ivume isicelo esitsha seyeza (sNDA) esikhethiweyo se-RET inhibitor GAVRETO® (pralsetinib) yonyango lwe-RET-mutant medullary thyroid cancer (MTC) kunye ne-RET fusion. -umhlaza we-thyroid (TC). Ulwamkelo lwandise imiqondiso ebhalwe nge-GAVRETO e-China ukubandakanya abantu abadala kunye nabaguli abangabantwana abaneminyaka eli-12 ubudala nangaphezulu abane-RET-mutant MTC ephezulu okanye enemetastatic efuna unyango olucwangcisiweyo, kunye nezigulana zabantu abadala kunye nabantwana abaneminyaka eyi-12 ubudala nangaphezulu abane-metastatic okanye i-metastatic. I-RET fusion-positive TC efuna unyango lwenkqubo kunye ne-radioactive iodine-refractory (ukuba unyango lwe-iodine ye-radioactive lufanelekile).

Ifunyanwe liqabane le-CStone i-Blueprint Medicines, i-GAVRETO yi-RET inhibitor enamandla kwaye ekhethiweyo. I-CStone inentsebenziswano ekhethekileyo kunye nemvumelwano yelayisensi kunye ne-Blueprint Medicines yophuhliso kunye nokuthengiswa kwe-GAVRETO e-Greater China, equka i-Mainland China, i-Hong Kong, i-Macau ne-Taiwan.

UDkt Frank Jiang, uSihlalo kunye ne-CEO ye-CSstone, uthe, "Siyavuya kakhulu malunga nokuvunywa kwe-sNDA ye-GAVRETO, eya kubonelela ngokhetho olutsha lonyango lwezigulane zaseTshayina ezinomdlavuza we-RET-mutant medullary thyroid kunye ne-RET fusion-positive thyroid cancer. . Sikwafuna ukudlulisa imibulelo yethu eyodwa kwi-NMPA ngophononongo oluphambili. I-CStone isoloko izibophelele ekuphuhliseni iindlela zonyango ezitsha zokujongana nezidingo zonyango ezingafezekanga zabaguli abanomhlaza. Siza kuqhubeka nokuphucula ixabiso leklinikhi kunye nokubanakho kombhobho wethu, kwaye sinyuse iinzame zokubonelela izigulana kwihlabathi jikelele ngomgangatho ophezulu, amayeza amatsha. "

Unjingalwazi uMing Gao, uMphandi oPhambili we-ARROW kunye noMongameli weZiko lezoNyango le-Tianjin Union, uthe, "Izinga leziganeko zomhlaza we-thyroid liye lakhula kwiminyaka yamuva. Kukho iindlela zonyango ezilinganiselweyo zonyango lwe-MTC, kwaye kukho imfuno engxamisekileyo yonyango oluchanekileyo, ngakumbi kwizigulane ezine-RET-mutant MTC. I-GAVRETO ibonise umsebenzi oqinileyo kunye nexesha elide lokulwa ne-tumor kwizigulana zaseTshayina ezine-MTC ephuculweyo okanye ye-metastatic ye-RET, kunye nokhuseleko olupheleleyo oluhambelana neziphumo ezibonwe kuphononongo lwe-ARROW yehlabathi. Ngolu lwandiso lwezalathisi ezibhalwe nguGAVRETO, sijonge phambili ekujonganeni neemfuno zeklinikhi ezingafezekanga zabaguli abanomhlaza wethyroid.

UGqr. Jason Yang, iGosa eliyiNtloko lezoNyango lwe-CSstone, uthe, "Ukuvunywa kwe-NMPA ye-sNDA sesinye isiganeko esibalulekileyo kuthi emva kokuba i-GAVRETO ivunyiwe kunyango lwezigulane ezinomdlavuza we-RET ophucukileyo okanye we-metastatic we-fusion-positive non-small cell lung cancer. . Sithanda ukubulela zonke izigulana kunye nabaphandi abathe banegalelo kuphononongo lwezonyango lwe-GAVRETO kwizalathisi ezandisiweyo. Siza kuqhubeka nokuqhubela phambili uphando lwezonyango lwe-GAVRETO kunyango lweentlobo ezininzi zomhlaza ukuze sikhawuleze ukuzisa olu nyango lunolutsha ukunceda izigulana ezininzi. ”

Ukuvunywa kwe-sNDA kusekelwe kwiziphumo ezivela kwisigaba sehlabathi se-1/2 yolingo lwe-ARROW, eyenzelwe ukuhlola ukhuseleko, ukunyamezela kunye nokusebenza kakuhle kwe-GAVRETO kwizigulane ezine-RET fusion-positive NSCLC, i-RET-mutant MTC, kunye nezinye iithumba eziqinileyo eziqhubela phambili ezine-RET fusions. . Ukusukela ngomhla we-12 ka-Epreli, ngo-2021, iyonke yezigulana ezingama-28 ezine-RET-mutant MTC ephucukileyo zabhaliswa kwiqela lobhaliso lobhaliso lwaseTshayina MTC kuphononongo lwe-ARROW yehlabathi, kwaye bafumana idosi yokuqala ye-GAVRETO ye-400mg kanye yonke imihla. Iziphumo zophando zibonise ukuba izinga lempendulo yenjongo eqinisekisiweyo (ORR) yezigulane ze-26 RET-mutant MTC ezinezifo ezinokulinganiswa kwisiseko yi-73.1%, kubandakanywa ne-3 eneempendulo ezipheleleyo (CR) kunye ne-16 ngeempendulo eziyingxenye (PR). Izinga lokulawula isifo (i-DCR) laliyi-84.6%, kwaye iimpendulo zabonwa kungakhathaliseki ukuba i-RET mutation genotype. Phakathi kwezigulane ze-19 ezinempendulo eqinisekisiweyo, ixesha eliphakathi lokuphendula (i-DOR) alizange lifikelelwe, kwaye izinga le-DOR lenyanga ye-9 laliyi-100%. Amanqanaba eCalcitonin kunye ne-carcinoembryonic antigen (CEA) aye ancitshiswa kakhulu. I-GAVRETO yayinyamezeleke kakuhle, kungekho zimpawu zintsha zokhuseleko zifunyenweyo. Iziphumo zeqela laseTshayina lokubhalisa ibridging zithiwe thaca ngexesha lokwaphulwa kade kweseshini yomlomo kwiNtlanganiso yoNyaka yama-90 yeAmerican Thyroid Association (ATA) 2021.