Pa Disembala 04, 2024, New Drug Application (NDA) yophatikiza TYVYT® (jakisoni wa sintilimab) ndi ELUNATE® (fruquintinib) yavomerezedwa ku China kuti ichite chithandizo cha odwala omwe ali ndi khansa ya endometrial yapamwamba omwe ali ndi zotupa za Mismatch Repair proficient (pMMR) zomwe sizinachite bwino kale ndipo sizili zoyenera kuchitidwa opaleshoni yochiritsa kapena radiation. Chivomerezochi chikutsatira momwe zinthu zilili komanso kusankhidwa kwa chithandizo chotsogola ndi National Medical Products Administration (NMPA) ya ku China ndipo chikuwonetsa chizindikiro chachisanu ndi chitatu chovomerezeka cha TYVYT® (jakisoni wa sintilimab).
Kuvomerezedwa kokhazikika ndi NMPA kunathandizidwa ndi deta yolembetsa kuchokera ku FRUSICA-1, gulu lolembetsa khansa ya endometrial la kafukufuku wa Gawo 2 wokhala ndi malo ambiri, wotseguka wofufuza sintilimab pamodzi ndi fruquintinib mwa odwala khansa ya endometrial omwe adakumana ndi kubwereranso kwa matendawa, kupita patsogolo kwa matendawa kapena poizoni wosapiririka ndi chithandizo cha platinum-based doublet chemotherapy. Zotsatira za FRUSICA-1 zidaperekedwa pamsonkhano wapachaka wa American Society of Clinical Oncology mu June 2024.
AChiwerengero cha ma pMMR 98 omwe ali ndi vuto la pMMR adalembedwa ndipo adalandira chithandizo chophatikizana. Ma pts onse adalandira kale chithandizo chamankhwala cha platinamu chokhazikika, ndipo ma pts 22.4% adalandira chithandizo cha bevacizumab. Mbiri yatsatanetsatane ya matenda yafotokozedwa mwachidule mu tebulo. Ndi nthawi yotsatila yapakati (95% CI) ya 15.7m (14.6, 17.7), ma pts 87/98 anali ndi zotsatira zosachepera chimodzi pambuyo pa kuyesa kwa chotupa (ma pts oyesedwa), pakati pawo, ORR ndi DCR zoyesedwa ndi IRC zinali 35.6% (CR: 2/87 ndi PR: 29/87) ndi 88.5% motsatana; DoR sinafike ndipo chiŵerengero cha 9m-DoR chinali 80.7%. Pakati pa mapointi 98, apakati (95% CI) PFS ndi OS anali 9.5m (5.6, -) ndi 21.3m (17.3, -) motsatana. Kutengera ndi chithandizo cha bevacizumab chakale, ORR inali 40.9% poyerekeza ndi 30.3%, ndipo apakati (95% CI) PFS anali 13.8m (4.1, -) poyerekeza ndi 9.5m (5.5, -).
Zochitika zoyipa zimagwirizana ndi zomwe zanenedwa pa chithandizo chofanana cha immunotherapy ndi mankhwala oletsa angiogenic.
About Sintilimab
Sintilimab, yomwe imagulitsidwa ngati TYVYT (jakisoni wa sintilimab) ku China, ndi antibody ya PD-1 immunoglobulin G4 monoclonal yomwe idapangidwa ndi Innovent ndi Eli Lilly and Company. Sintilimab ndi mtundu wa antibody ya immunoglobulin G4 monoclonal, yomwe imamangirira ku mamolekyu a PD-1 pamwamba pa maselo a T, imatseka njira ya PD-1 / PD-Ligand 1 (PD-L1), ndikuyambitsanso maselo a T kuti aphe maselo a khansa. Ku China, sintilimab yavomerezedwa ndipo yaphatikizidwa mu NRDL yosinthidwa kwa zizindikiro zisanu ndi ziwiri. Chiwerengero chosinthidwa cha NRDL chobwezera TYVYT (jakisoni wa sintilimab) chikuphatikizapo:
Pochiza matenda a Hodgkin's lymphoma omwe abwereranso kapena osachiritsika pambuyo pa chithandizo cha mankhwala a chemotherapy amitundu iwiri kapena kupitilira apo;
Pa chithandizo choyamba cha khansa ya m'mapapo ya non-squamous non-small cell yomwe singathe kuchiritsidwa yomwe ilibe EGFR kapena ALK driver gene mutations;
Kuchiza odwala omwe ali ndi khansa ya m'mapapo ya EGFR yomwe yasinthidwa m'deralo kapena yofalikira kwambiri yomwe si ya squamous non-small cell yomwe idakula pambuyo pa chithandizo cha EGFR-TKI;
Kuchiza khansa ya m'mapapo ya squamous non-small cell yomwe singathe kuchiritsidwa m'deralo kapena yofalikira m'thupi;
Pa chithandizo choyamba cha khansa ya chiwindi yosachira kapena yofalikira popanda chithandizo chamankhwala chokhazikika;
Pa chithandizo choyamba cha khansa ya squamous cell carcinoma yomwe singathe kuchiritsidwa m'deralo, yobwerezabwereza kapena yofalikira m'thupi;
Pa chithandizo choyamba cha adenocarcinoma ya m'mimba yosachira, yobwerezabwereza kapena yofalikira m'mimba kapena m'mimba.
Kuphatikiza apo, chizindikiro chachisanu ndi chitatu cha sintilimab, pamodzi ndi fruquintinib pochiza odwala omwe ali ndi khansa ya endometrial yapamwamba omwe ali ndi zotupa za pMMR zomwe sizinagwire ntchito kale ndipo sizili zoyenera kuchitidwa opaleshoni yochiritsa kapena radiation, zidavomerezedwa ndi NMPA mu Disembala 2024.
Kuphatikiza apo, maphunziro awiri azachipatala a sintilimab akwaniritsa zolinga zawo zazikulu:
Kuphunzira kwa gawo lachiwiri la sintilimab monotherapy ngati chithandizo chachiwiri cha khansa ya esophageal squamous cell carcinoma;
Kafukufuku wa Gawo 3 wa sintilimab monotherapy ngati chithandizo chachiwiri cha khansa ya m'mapapo ya squamous non-small cell yokhala ndi matenda opitilira pambuyo pa chemotherapy yochokera ku platinum.
About Fruquintinib
Fruquintinib ndi mankhwala oletsa kumwa osankhidwa a ma receptor onse atatu a vascular endothelial growth factor (“VEGF”) (VEGFR-1, -2 ndi -3). Ma VEGFR inhibitors amachita gawo lofunikira kwambiri poletsa angiogenesis ya chotupa. Fruquintinib idapangidwa kuti ikhale ndi kusankha bwino komwe kumaletsa ntchito ya kinase yomwe siili yolunjika, zomwe zimapangitsa kuti munthu azitha kugwiritsa ntchito mankhwala omwe amalepheretsa komanso kusinthasintha kuti agwiritsidwe ntchito ngati gawo la mankhwala ophatikizana.
Fruquintinib yavomerezedwa kuti igulitsidwe pochiza odwala omwe ali ndi khansa ya m'matumbo yomwe idafalikira omwe adalandira kale fluoropyrimidine, oxaliplatin ndi chemotherapy yochokera ku irinotecan, komanso omwe adalandira kale kapena omwe sali oyenera kulandira mankhwala oletsa VEGF kapena mankhwala oletsa kukula kwa epidermal factor receptor ("EGFR") (RAS wild-type) ku China, komwe imapangidwa ndi HUTCHMED ndi Eli Lilly and Company pansi pa dzina la ELUNATE. Idaphatikizidwa mu China National Reimbursement Drug List ("NRDL") mu Januwale 2020. Kuyambira pomwe idayambitsidwa ku China, odwala opitilira 100,000 omwe ali ndi khansa ya m'matumbo adachiritsidwa ndi fruquintinib.
Mu Disembala 2024, fruquintinib idavomerezedwa ndi NMPA pamodzi ndi sintilimab pochiza odwala omwe ali ndi khansa ya endometrial yapamwamba omwe ali ndi zotupa za pMMR zomwe sizinagwire ntchito kale ndipo sizili zoyenera opaleshoni yochiritsa kapena radiation.
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.
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Imelo：myimmnet@163.com
Zolemba
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241203153537120.html
2.https://cn.innoventbio.com/#/news/592
3.https://meetings.asco.org/abstracts-presentations/234546
4. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
5.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
Nthawi yotumizira: Disembala-16-2024