Disembala 20, 2024, Bungwe Loona za Mankhwala ku China (NMPA) lavomereza Pulogalamu Yatsopano ya Mankhwala (NDA) ya DOVBLERON ® (taletrectinib adipate capsule), choletsa cha ROS1 tyrosine kinase (TKI) cha m'badwo wotsatira, chochizira odwala akuluakulu omwe ali ndi khansa ya m'mapapo ya ROS1-positive non-small cell (NSCLC) yomwe yakula kwambiri kapena yofalikira kwambiri omwe adachiritsidwa kale ndi ROS1 TKIs.
Kuvomerezedwa kumeneku kumachokera ku zotsatira zabwino kuchokera ku mayeso ofunikira a Gawo 2 TRUST-I (NCT04395677), mayeso otseguka, a mkono umodzi omwe adayesa taletrectinib mwa odwala aku China omwe ali ndi NSCLC yapamwamba ya ROS1. Zomwe zapezeka, zomwe zidaperekedwa pa Msonkhano Wapachaka wa 2024 wa American Society of Clinical Oncology (ASCO) ndipo zidasindikizidwa mu Journal of Clinical Oncology (JCO), zawonetsa kuthekera kwa DOVBLERON® kuthana ndi zosowa zosakwaniritsidwa, makamaka kwa odwala omwe ali ndi njira zochepa zochiritsira atalandira chithandizo ndi mankhwala omwe adayang'aniridwa kale ndi ROS1.
Pofika pa Novembala 29, 2023, odwala 173 aku China (106 TKI naїve; 67 crizotinib-pretreated) adalandira taletrectinib. Pakati pa odwala 106 a TKI-naїve, cORR yoyesedwa ndi IRC inali 90.6% (95% CI, 83.33 mpaka 95.38) ndi odwala anayi (3.8%) omwe adakwanitsa CR ndi 92 (86.8%) omwe adakwanitsa PR. DCR inali 95.3% (95% CI, 89.33 mpaka 98.45), ndipo TTR yapakati inali miyezi 1.4 (95% CI, 1.38 mpaka 1.41). Ndi kutsatiridwa kwapakati kwa miyezi 22.1 ndi miyezi 23.5, palibe DOR yapakati kapena PFS yapakati yomwe idafikiridwa; DOR ndi PFS ya miyezi 24 zinali 78.6% (95% CI, 66.86 mpaka 86.56) ndi 70.5% (95% CI, 59.17 mpaka 79.16), motsatana.
Pakati pa odwala 66 omwe adalandira crizotinib asanalandire chithandizo, cORR yoyesedwa ndi IRC inali 51.5% (95% CI, 38.88 mpaka 64.01) ndipo odwala 34 (51.5%) adapeza PR. DCR inali 83.3% (95% CI, 72.13 mpaka 91.38), ndipo TTR yapakati inali miyezi 1.4 (95% CI, 1.38 mpaka 1.41). Ndi miyezi 8.4 ndi miyezi 9.7 yotsatiridwa, DOR yapakati inali miyezi 10.6 (95% CI, 6.31 mpaka sinafike [NR]), ndipo PFS yapakati inali miyezi 7.6 (95% CI, 5.52 mpaka 11.96). Miyezo ya DOR ndi PFS ya miyezi 9 inali 69.8% (95% CI, 47.94 mpaka 83.84) ndi 47.4% (95% CI, 33.50 mpaka 60.02), motsatana. Zotsatira zofananazo zinawonedwa pamene ofufuza anawunika.
About DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® ndi mankhwala opangidwa ndi mkamwa, amphamvu, ogwirira ntchito m'mitsempha yapakati, osankha, komanso a m'badwo wotsatira a ROS1
inhibitor yopangidwira makamaka kuchiza odwala omwe ali ndi ROS1-positive NSCLC yapamwamba. Taletrectinib, mankhwala ogwiritsira ntchito mu DOVBLERON ® akuyesedwa kuti athandize odwala omwe ali ndi ROS1-positive NSCLC yapamwamba m'maphunziro awiri a Phase 2 single-arm pivotal: TRUST-I (NCT04395677) ku China, ndi TRUST-II (NCT04919811), kafukufuku wapadziko lonse lapansi.
Khansa ya m'mapapo ikupitirirabe kukhala ndi chiwerengero chachikulu kwambiri cha anthu padziko lonse lapansi komanso chiwerengero cha imfa, ndipo NSCLC ikuwerengera pafupifupi 85% ya milandu yonse. Ku China, akuti pafupifupi 2.6% ya odwala omwe ali ndi NSCLC ali ndi ROS1-positive. Kuphatikiza apo, metastases ya ubongo ndi vuto lofala, lomwe limakhudza mpaka 35% ya odwala omwe angopezeka ndi NSCLC ya ROS1-positive, ndipo likuwonjezeka kufika pa 55% ya odwala omwe khansa yawo yapita patsogolo atalandira chithandizo choyamba. Kuphatikiza apo, odwala omwe amalandira chithandizo cha ROS1 TKIs chovomerezeka nthawi zambiri amakhala ndi kusintha kwa kukana mankhwala awa, zomwe zimapangitsa kuti odwala asamayankhe nthawi yayitali. Kuvomerezedwa kwa DOVBLERON® kumapereka njira yatsopano komanso yothandiza yothandizira odwala omwe sakuyankhanso mankhwala omwe adavomerezedwa kale.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Imelo：myimmnet@163.com
Zolemba
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Kulengeza kwa atolankhani (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
Nthawi yotumizira: Disembala-27-2024