Ngo-Ephreli 25, 2025, i-InnoCare Pharma yamemezela ukuthi isizukulwane sayo esisha se-pan-TRK inhibitor zurletrectinib (ICP-723) sinikezwe ukubuyekezwa okubalulekile yi-Center for Drug Evaluation (CDE) ye-China National Medical Products Administration (NMPA), eyamukela i-New Drug Application (NDA) ye-zurletrectinib yokwelapha iziguli ezinezimila eziqinile ezithuthukile eziqukethe ukuhlanganiswa kwezakhi zofuzo ze-NTRK muva nje. Ukubuyekezwa okubalulekile kungenye yezinqubomgomo ezibalulekile ezethulwe yi-CDE ukusheshisa ukuvunyelwa kwemithi.
Esivivinyweni sokubhalisa seziguli ezine-NTRK fusion-positive solid tumors, i-zurletrectinib ibonise ukusebenza kahle okuvelele ngephrofayili enhle yokuphepha.
UDkt. Jasmine Cui, umsunguli, usihlalo kanye ne-CEO ye-InnoCare, uthe, “Siyajabula ukuthi i-zurletrectinib inikezwe ukubuyekezwa okubalulekile. I-Zurletrectinib ibonise ukusebenza kahle okuvelele kanye nephrofayili yokuphepha enhle. Silindele ukuthi izohlinzeka ngezinketho zokwelapha ezingcono kakhulu ezigulini ezifanelekile ezinezimila eziqinile kusenesikhathi.”
I-Zurletrectinib iyi-pan-TRK inhibitor eyasungulwa yi-InnoCare. I-British Journal of Cancer, eyingxenye yephephabhuku lesayensi elihamba phambili i-Nature, ishicilele iphepha elinesihloko esithi “I-Zurletrectinib iyi-TRK inhibitor yesizukulwane esilandelayo enomsebenzi oqinile wangaphakathi kwekhanda ngokumelene nezimila ze-NTRK fusion ezinokumelana okuqondile nezidakamizwa zesizukulwane sokuqala”.
Leli phepha liveze ukuthi i-zurletrectinib ibonise amandla aqinile ngokumelene ne-TRKA, TRKB, kanye ne-TRKC WT kinases, kanye nokuguqulwa kokumelana okutholiwe kwe-TRKA G595R kanye ne-TRKA G667C. I-Zurletrectinib yayisebenza kakhulu kunezinye izizukulwane zokuqala ezivunyelwe yi-FDA noma ezihlolwe ngokwezokwelapha (i-larotrectinib) kanye nezizukulwane ezilandelayo (i-selitrectinib kanye ne-repotrectinib) TRK inhibitors ngokumelene nezinhlobo eziningi zokuguqulwa kokumelana kwe-TRK inhibitors. Ngokufanayo, i-zurletrectinib (1 mg/kg BID) yavimbela ukukhula kwesimila kumamodeli e-xenograft atholakala kumaseli e-NTRK fusion-positive ngesilinganiso esiphansi ngokuphindwe ka-30 uma kuqhathaniswa ne-selitrectinib.
Leli phepha liphinde labonisa ukuthi, ocwaningweni lwe-CNS penetrant pharmacokinetic kumagundane e-SD, i-zurletrectinib ibonise ikhono elithuthukisiwe lokungena emgodleni wegazi nobuchopho, ifinyelela ebuchosheni ngempumelelo kakhulu kune-selitrectinib kanye ne-repotrectinib. Ukungena kobuchopho okwandisiwe kwe-Zurletrectinib nakho kwahunyushwa kwaba umsebenzi othuthukisiwe wokulwa nomdlavuza. Kumodeli ye-xenograft yegundane le-orthotopic glioma ephethe ukuguqulwa kokumelana kwe-TRKA G598R/G670A, i-zurletrectinib (15 mg/kg) ithuthukise kakhulu ukusinda kwamagundane aphethe i-orthotopic NTRK fusion-positive, TRK-mutant gliomas (ukusinda okumaphakathi = izinsuku ezingu-41.5, 66.5, kanye nezinsuku ezingu-104 ze-selitrectinib, repotrectinib, kanye ne-zurletrectinib ngokulandelana; P < 0.05), okubonisa ukusebenza kahle okuphezulu uma kuqhathaniswa ne-repotrectinib (15 mg/kg) kanye ne-selitrectinib (30 mg/kg) (P=0.0384 kanye no-0.0022, ngokulandelana), enephrofayili yokuphepha enhle kakhulu.
Izakhi zofuzo ze-NTRK fusion zenzeka ezinhlotsheni ezahlukene zezimila zabantu abadala kanye nezingane. Kwezinye izimila ezingavamile, njenge-salivary gland carcinoma, umdlavuza webele oyimfihlo, kanye ne-infantile fibrosarcoma, izinga lokuhlanganiswa kwezakhi zofuzo ze-NTRK lidlula u-90%. Kulinganiselwa ukuthi kunezimo ezintsha ezingaba ngu-6,500 zezimila eziqinile ze-NTRK fusion-positive ezitholakala eShayina minyaka yonke. Kunezidingo ezibalulekile zezokwelapha ezingakahlangatshezwa kule ndawo ngenxa yokuntuleka kwezinketho zokwelapha ezisebenzayo.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Meyi-07-2025