Zvita 20, 2024, National Medical Products Administration (NMPA) yeChina yakabvumidza New Drug Application (NDA) yeDOVBLERON ® (taletrectinib adipate capsule), mushonga unodzivirira chirwere cheROS1 tyrosine kinase (TKI) wechizvarwa chinotevera, wekurapa varwere vakuru vane kenza yemapapu yemhando yepamusoro kana kuti yakapararira yeROS1-positive non-small cell cancer (NSCLC) avo vakamborapwa neROS1 TKIs.
Kubvumidzwa uku kwakavakirwa pamhedzisiro yakanaka kubva mukuyedzwa kwakakosha kwePhase 2 TRUST-I (NCT04395677), bvunzo yenzvimbo dzakawanda, yakavhurika, ine ruoko rumwe chete yakaongorora taletrectinib muvarwere vekuChina vane ROS1-positive NSCLC yepamusoro. Zvakawanikwa, zvakapihwa paMusangano weGore negore we2024 American Society of Clinical Oncology (ASCO) uye zvakaburitswa muJournal of Clinical Oncology (JCO), zvakaratidza kugona kweDOVBLERON® kugadzirisa zvinodiwa zvisina kuzadzikiswa, kunyanya muvarwere vane nzira shoma dzekurapa mushure mekurapwa nemishonga yakambotarirwa neROS1.
Kubva musi wa29 Mbudzi, 2023, varwere vekuChina 173 (106 TKI naїve; 67 crizotinib-pretreated) vakagamuchira taletrectinib. Pakati pevarwere 106 TKI-naїve, IRC-assessed cORR yaive 90.6% (95% CI, 83.33 kusvika 95.38) nevarwere vana (3.8%) vakawana CR uye 92 (86.8%) vakawana PR. DCR yaive 95.3% (95% CI, 89.33 kusvika 98.45), uye avhareji TTR yaive mwedzi 1.4 (95% CI, 1.38 kusvika 1.41). Nekuteverwa kwepakati kwemwedzi 22.1 nemwedzi 23.5, hapana avhareji DOR kana avhareji PFS yakawanikwa; DOR nePFS zvemwedzi makumi maviri nemana zvaive 78.6% (95% CI, 66.86 kusvika 86.56) uye 70.5% (95% CI, 59.17 kusvika 79.16), zvichiteerana.
Pakati pevarwere makumi matanhatu nematanhatu vakarapwa crizotinib vasati vawana mushonga, IRC-assessed cORR yaive 51.5% (95% CI, 38.88 kusvika 64.01) nevarwere makumi matatu nemana (51.5%) vakawana PR . DCR yaive 83.3% (95% CI, 72.13 kusvika 91.38), uye avhareji yeTTR yaive 1.4 mwedzi (95% CI, 1.38 kusvika 1.41). Nemwedzi 8.4 nemwedzi 9.7 yekutevera, avhareji yeDOR yaive 10.6 mwedzi (95% CI, 6.31 kusvika isina kusvika [NR]), uye avhareji yePFS yaive 7.6 mwedzi (95% CI, 5.52 kusvika 11.96). Mwero wemwedzi mipfumbamwe weDOR nePFS waive 69.8% (95% CI, 47.94 kusvika 83.84) uye 47.4% (95% CI, 33.50 kusvika 60.02), zvichiteerana. Mhedzisiro yakafanana yakaonekwa pakaongororwa nevaongorori.
About DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® mushonga wemuromo, une simba, unoshanda mutsinga dzemukati, unosarudza, uye wechizvarwa chinotevera cheROS1
inhibitor yakagadzirirwa kurapa varwere vane ROS1-positive NSCLC yepamusoro. Taletrectinib, chinhu chinoshanda muDOVBLERON ® chiri kuongororwa kurapa varwere vane ROS1-positive NSCLC yepamusoro muzvidzidzo zviviri zvePhase 2 single-arm pivotal: TRUST-I (NCT04395677) muChina, uye TRUST-II (NCT04919811), chidzidzo chepasi rose.
Kenza yemapapu ichiri kuramba iine huwandu hwakanyanya hwezvirwere pasi rose uye huwandu hwerufu, NSCLC ichiverengera 85% yezvirwere zvese. MuChina, zvinofungidzirwa kuti vanenge 2.6% yevarwere vanorarama neNSCLC vane ROS1-positive. Uyezve, metastases yeuropi idambudziko rakajairika, richibata kusvika ku35% yevarwere vachangoonekwa vaine ROS1-positive NSCLC, uye rinowedzera kusvika ku55% yevarwere vane kenza yakawedzera mushure mekurapwa kwekutanga. Pamusoro pezvo, varwere vanorapwa neROS1 TKIs dzakatenderwa vanowanzo gadzira shanduko dzekudzivirira kurapwa uku, zvichimiririra muganho mukuru kune varwere maererano nenguva yekupindura. Kubvumidzwa kweDOVBLERON® kunopa sarudzo itsva uye inoshanda yekurapa kune varwere vasingachapinduri kurapwa kwakatenderwa kare.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Imeyili：myimmnet@163.com
Mareferensi
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Chiziviso cheVatori Venhau (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
Nguva yekutumira: Zvita-27-2024