Kua Whakaaetia e te NMPA te Tohu Tuaiwa o Anlotinib: Te Rongoā Tuatahi mō te Sarcoma Tissue Ngāwari Matatau

I te 30 o Hune, i panuitia e te paetukutuku mana o te National Medical Products Administration (NMPA) kua whakaaetia a Anlotinib, he rongoā hou Akomanga 1 i whakawhanakehia e Chia Tai Tianqing, mō tētahi tohu hou i Haina: te whakakotahitanga o te rongoā me te chemotherapy mō te maimoatanga raina-tuatahi o ngā tūroro he mate pukupuku uaua kua horapa, kua horapa rānei (STS) kāore anō kia whiwhi i te rongoā pūnaha i mua. Koinei te tohu tuaiwa kua whakaaetia mō Anlotinib i Haina, ā, e tohu ana i te whakaae mana o te whakakotahitanga o te rongoā chemotherapy tuatahi o te ao mō te maimoatanga raina-tuatahi o ngā STS kua horapa, kua horapa rānei.

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Ko te Anlotinib (AL3818, Anlotinib Hydrochloride) he aukati tyrosine kinase maha-whāinga (TKI) ngota iti hou e aukati ana i ngā kinase pēnei i te VEGFR, PDGFR, FGFR, me te c-Kit, e whakaatu ana i ngā pānga ārai-angiogenesis pukupuku me te aukati i te tipu pukupuku.

Ko te sarcoma kiko ngohengohe (STS) he momo pukupuku kino e ahu mai ana i ngā kiko kore-epithelial extraskeletal, me te reiti tau o te mate tata ki te 2.91 mō ia 100,000 taupori i Haina, e whakaatu ana i te pikinga ake i ia tau [1-3]. Kei roto i te STS te 19 ngā momo histological me te neke atu i te 50 ngā momo pathological motuhake. Mō ngā tekau tau, ko te chemotherapy e hangai ana ki te anthracycline te tūāpapa o te maimoatanga raina tuatahi mō te STS.

I te Hui-ā-Tau a te American Society of Clinical Oncology (ASCO) i te tau 2025, i whakaatuhia e te kamupene ngā hua hou o te rangahau haumanu Wāhanga III o ngā Kāpū Anlotinib Hydrochloride me te chemotherapy mō te maimoatanga tuatahi o ngā STS matatau, kua horapa rānei, kāore e taea te tango.

 

Ngā Tikanga: Ko ngā tāngata whai mana kua whiwhi i ngā STS kua horapa ā-rohe, kua whakaūngia e te mate, kāore i taea te tango, kua horapa rānei. I matapōkeretia ngā tāngata i roto i te ōwehenga 1:1 kia whiwhi i te ALTN (12mg) ā-waha kotahi i te rā (2-wiki i te wā e rongoa ana/1-wiki whakatā) me te EH (90 mg/m2) mā te uaua kotahi i te 3 wiki tae atu ki te 6 huringa, ā, whai muri ko te ALTN pupuri (12mg) ā-waha kotahi i te rā (2-wiki i te wā e rongoa ana/1-wiki whakatā) me te PBO (0mg) ā-waha kotahi i te rā (2-wiki i te wā e rongoa ana/1-wiki whakatā) me te EH (90 mg/m2) mā te uaua kotahi i te 3 wiki tae atu ki te 6 huringa, ā, whai muri ko te PBO pupuri (0mg) ā-waha kotahi i te rā (2-wiki i te wā e rongoa ana/1-wiki whakatā). Ko te pito whakamutunga tuatahi i aromatawaitia e te komiti arotake motuhake matapo e ai ki te RECIST 1.1. Ko te pito whakamutunga tuarua ko te OS, te Whāinga Urupare Whāinga (ORR), te tere whakahaere mate (DCR) me te haumaru.

Ngā Hua: E 272 ngā tohu i matapōkeretia: 135 ki te ringa ALTN + EH, 137 ki te ringa PBO + EH. I te 15 o Pēpuere, 2024, whai muri i te aroturukitanga toharite o te 7.16 marama, i tino whakapai ake te ringa ALTN + EH i te PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; toharite 8.57 vs 3.02 marama), me te ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) ki te ringa PBO + EH. Kāore i eke ki te OS toharite i roto i tētahi o ngā ringa (HR = 0.78 [95% CI: 0.49-1.25]). I kitea te painga o te ringa ALTN + EH puta noa i te nuinga o ngā rōpū iti i whakamatautauria, tae atu ki te leiomyosarcoma, te synovial sarcoma me ētahi atu momo mate. He rite tonu te auau o ngā pānga kino (AE) o te Reanga ≥3 (69.6% vs 59.1%), ngā AE e arahi ana ki te whakamutua o te maimoatanga (3.7% vs 4.4%), me ngā AE whakamate (3.7% vs 3.6%) i waenga i ngā ringa e rua.

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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Te wā tuku: Hōngongoi-01-2025