Diseembar 20, 2024, Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ansixiyay Codsiga Daawada Cusub (NDA) ee DOVBLERON® (taletrectinib adipate capsule), oo ah daawada jiilka xiga ee ROS1 tyrosine kinase inhibitor (TKI), si loogu daaweeyo bukaanada qaangaarka ah ee qaba kansarka sambabada ee unugyada yaryar ee aan ahayn unugyada yar ee ROS1-positive (NSCLC) ee maxalliga ah ama aan la saadaalin karin ee metastatic-ka ah kuwaas oo hore loogu daaweeyay ROS1 TKIs.
Ansixintu waxay ku salaysan tahay natiijooyin wanaagsan oo ka soo baxay tijaabada muhiimka ah ee Wejiga 2aad ee TRUST-I (NCT04395677), tijaabo hal-gacan ah oo xarun badan leh, oo furan, oo qiimaysay taletrectinib bukaanada Shiinaha ee qaba NSCLC-ga ROS1-positive ee horumarsan. Natiijooyinka, oo lagu soo bandhigay Shir-sannadeedka Ururka Mareykanka ee Kansarka Kiliinikada (ASCO) ee 2024 laguna daabacay Joornaalka Kansarka Kiliinikada (JCO), waxay muujiyeen awoodda DOVBLERON® si wax looga qabto baahiyaha aan la dabooli karin, gaar ahaan bukaanada leh ikhtiyaarro daaweyn oo xaddidan ka dib daaweynta daaweynta hore ee ROS1.
Laga bilaabo Noofambar 29, 2023, 173 bukaan oo Shiinees ah (106 TKI naїve; 67 crizotinib-pretreated) ayaa la siiyay taletrectinib. 106 bukaan oo TKI naїve ah, cORR-ka IRC-ga lagu qiimeeyay wuxuu ahaa 90.6% (95% CI, 83.33 ilaa 95.38) iyadoo afar (3.8%) bukaan ay gaareen CR iyo 92 (86.8%) ay gaareen PR. DCR wuxuu ahaa 95.3% (95% CI, 89.33 ilaa 98.45), TTR-ka dhexdhexaadka ahna wuxuu ahaa 1.4 bilood (95% CI, 1.38 ilaa 1.41). Iyadoo la raacayo dhexdhexaadka 22.1 bilood iyo 23.5 bilood, midkoodna DOR dhexdhexaad ah ama PFS dhexdhexaad ah lama gaarin; DOR iyo PFS oo 24-bilood jiray waxay ahaayeen 78.6% (95% CI, 66.86 ilaa 86.56) iyo 70.5% (95% CI, 59.17 ilaa 79.16), siday u kala horreeyaan.
66 bukaan oo lagu daaweeyay crizotinib, cORR-ka IRC-ga lagu qiimeeyay wuxuu ahaa 51.5% (95% CI, 38.88 ilaa 64.01) iyadoo 34 (51.5%) bukaan ay gaareen heerka PR. DCR wuxuu ahaa 83.3% (95% CI, 72.13 ilaa 91.38), TTR-ka dhexdhexaadka ahna wuxuu ahaa 1.4 bilood (95% CI, 1.38 ilaa 1.41). Iyadoo 8.4 bilood iyo 9.7 bilood la socday, DOR-ka dhexdhexaadka ah wuxuu ahaa 10.6 bilood (95% CI, 6.31 ilaa aan la gaarin [NR]), PFS-ka dhexdhexaadka ahna wuxuu ahaa 7.6 bilood (95% CI, 5.52 ilaa 11.96). Heerarka DOR iyo PFS ee 9-bilood jiray waxay ahaayeen 69.8% (95% CI, 47.94 ilaa 83.84) iyo 47.4% (95% CI, 33.50 ilaa 60.02), siday u kala horreeyaan. Natiijooyin la mid ah ayaa la arkay markii ay qiimeeyeen baarayaashu.
Ku saabsan DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® waa dawo afka laga qaato, awood leh, oo habdhiska neerfaha dhexe-firfircoon, xulasho leh, oo jiilka xiga ee ROS1 ah.
Dawada ka hortagga ee si gaar ah loogu talagalay daaweynta bukaanada qaba NSCLC-ga ROS1-positive ee horumarsan. Taletrectinib, oo ah walaxda firfircoon ee ku jirta DOVBLERON ®, ayaa lagu qiimeynayaa daaweynta bukaanada qaba NSCLC-ga ROS1-positive ee horumarsan laba daraasadood oo hal-gacan ah oo wejiga 2 ah: TRUST-I (NCT04395677) ee Shiinaha, iyo TRUST-II (NCT04919811), oo ah daraasad caalami ah.
Kansarka sambabada ayaa weli leh mid ka mid ah dhacdooyinka ugu badan adduunka iyo heerarka dhimashada, iyadoo NSCLC ay tahay qiyaastii 85% dhammaan kiisaska. Shiinaha, waxaa lagu qiyaasaa in qiyaastii 2.6% bukaannada la nool NSCLC ay yihiin kuwa qaba ROS1-positive. Intaa waxaa dheer, kansarka maskaxda ayaa ah caqabad caadi ah, taasoo saameysa ilaa 35% bukaannada cusub ee lagu ogaaday ROS1-positive NSCLC-ga, waxayna kor u kacaysaa ilaa 55% bukaannada kansarkoodu uu horumaray ka dib daaweynta bilowga ah. Intaa waxaa dheer, bukaanada lagu daaweeyay ROS1 TKIs-ka la ansixiyay waxay badanaa yeeshaan isbeddelo iska caabin ah oo ku yimaada daaweyntan, taasoo ka dhigan xaddidaad weyn oo bukaanada ah marka loo eego muddada jawaabta. Ansixinta DOVBLERON® waxay bixisaa ikhtiyaar daaweyn oo cusub oo wax ku ool ah bukaanada aan hadda ka jawaabin daaweynta hore loo ansixiyay.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
Lambarka Taleefanka: 4008803716
Iimayl:myimmnet@163.com
Tixraacyada
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.War-saxaafadeed (innoventbio.com)
3.https://ascopubs.org/doi/10.1200/JCO.24.00731?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Waqtiga boostada: Diseembar-27-2024