Hakihea 20, 2024, kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) tētahi Tono Rongoā Hou (NDA) o te DOVBLERON ® (taletrectinib adipate capsule), he aukati ROS1 tyrosine kinase (TKI) o te whakatupuranga e whai ake nei, hei rongoā i ngā tūroro pakeke e pangia ana e te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua horapa ki te rohe, kua horapa rānei, kua rongoatia i mua ki ngā ROS1 TKI.
Ko te whakaaetanga i ahu mai i ngā hua pai mai i te whakamātautau TRUST-I Wāhanga 2 (NCT04395677), he whakamātautau maha-pokapū, tuwhera-tapanga, kotahi-ringa i arotake i te taletrectinib i roto i ngā tūroro Hainamana me te NSCLC ROS1-pai matatau. Ko ngā kitenga, i whakaaturia i te Hui-ā-Tau a te American Society of Clinical Oncology (ASCO) 2024, ā, i whakaputaina ki te Journal of Clinical Oncology (JCO), i whakaatu i te kaha o DOVBLERON® ki te aro ki ngā hiahia kāore anō kia tutuki, inā koa i roto i ngā tūroro he iti noa ngā kōwhiringa rongoā i muri i te maimoatanga me ngā maimoatanga ROS1-whaiaro o mua.
I te 29 o Noema, 2023, 173 ngā tūroro Hainamana (106 kāore anō kia whiwhi i te TKI; 67 i mua i te maimoatanga i te crizotinib) i whiwhi i te taletrectinib. I roto i ngā tūroro 106 kāore anō kia whiwhi i te TKI, ko te cORR i aromatawaitia e te IRC he 90.6% (95% CI, 83.33 ki te 95.38) me te whā (3.8%) tūroro i whiwhi i te CR me te 92 (86.8%) i whiwhi i te PR. Ko te DCR he 95.3% (95% CI, 89.33 ki te 98.45), ā, ko te TTR toharite he 1.4 marama (95% CI, 1.38 ki te 1.41). Me te aroturukitanga toharite o te 22.1 marama me te 23.5 marama, kāore i eke ki te DOR toharite, ki te PFS toharite rānei; ko te DOR me te PFS 24-marama he 78.6% (95% CI, 66.86 ki te 86.56) me te 70.5% (95% CI, 59.17 ki te 79.16), ia.
I roto i ngā tūroro 66 i mua i te maimoatanga o te crizotinib, ko te cORR i aromatawaihia e te IRC he 51.5% (95% CI, 38.88 ki te 64.01) me te 34 (51.5%) tūroro i tutuki te PR. Ko te DCR he 83.3% (95% CI, 72.13 ki te 91.38), ā, ko te TTR toharite he 1.4 marama (95% CI, 1.38 ki te 1.41). Me te 8.4 marama me te 9.7 marama o te aroturukitanga, ko te DOR toharite he 10.6 marama (95% CI, 6.31 ki te kore i tae ki [NR]), ā, ko te PFS toharite he 7.6 marama (95% CI, 5.52 ki te 11.96). Ko ngā reiti DOR me PFS 9-marama he 69.8% (95% CI, 47.94 ki te 83.84) me te 47.4% (95% CI, 33.50 ki te 60.02), ia. I kitea ngā hua ōrite i te aromatawai a ngā kairangahau.
Mo DOVBLERON ® (Taletrectinib Adipate Capsule)
He rongoā ā-waha, he kaha, he kaha ki te pūnaha io matua, he whiriwhiri, he ROS1 o te whakatupuranga hou, a DOVBLERON ®.
he aukati i hangaia mō te rongoā i ngā tūroro he NSCLC ROS1-pai kua matatau. Kei te arotakehia te Taletrectinib, te matū hohe i roto i te DOVBLERON ®, mō te rongoā i ngā tūroro he NSCLC ROS1-pai kua matatau i roto i ngā rangahau matua e rua o te Wāhanga 2: TRUST-I (NCT04395677) i Haina, me TRUST-II (NCT04919811), he rangahau ā-ao.
Ko te mate pukupuku pūkahukahu tētahi o ngā mea tino nui rawa atu o te ao, ā, ko te NSCLC te 85% o ngā take katoa. I Haina, e kiia ana ko te 2.6% o ngā tūroro e ora ana me te NSCLC he ROS1-pai. Hei tāpiri, he wero noa te horapa o te mate ki roto i te roro, e pā ana ki te 35% o ngā tūroro kua kitea houtia he ROS1-pai te horapa o te mate NSCLC, ā, e piki haere ana ki te 55% o ngā tūroro kua whanake haere te mate pukupuku i muri i te maimoatanga tuatahi. Hei tāpiri, he maha ngā wā ka puta he ātete ki ngā rongoā i roto i ngā tūroro e rongoatia ana ki ngā ROS1 TKI kua whakaaetia, he herenga nui tēnei mō ngā tūroro e pā ana ki te roa o te urupare. Mā te whakaaetanga o DOVBLERON® ka whakaratohia he kōwhiringa maimoatanga hou, whai hua hoki mō ngā tūroro kāore e aro ana ki ngā rongoā kua whakaaetia i mua.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Ngā Tohutoro
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Pānui Pāpāho (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
Wā tuku: Hakihea-27-2024