Musi wa4 Zvita 2024, New Drug Application (NDA) yemusanganiswa weTYVYT® (sintilimab injection) neELUNATE® (fruquintinib) yakapihwa mvumo muChina yekurapa varwere vane kenza yepamusoro ye endometrial vane Mismatch Repair proficient (pMMR) bundu dzakambotadza kurapwa uye dzisiri dzekurapa kana radiation. Mvumo iyi inotevera mamiriro ekuongorora kwekutanga uye kusarudzwa kwekurapa kwakabudirira neNational Medical Products Administration (NMPA) yeChina uye inoratidza chiratidzo chechisere chakabvumidzwa cheTYVYT® (sintilimab injection).
Kubvumidzwa kwakaitwa neNMPA kwakatsigirwa nedata rekunyoresa kubva kuFRUSICA-1, boka rekunyoresa kenza yemukati mechibereko reongororo yechikamu chechipiri chedzidzo ine nzvimbo dzakawanda, yakavhurika, yakaongorora sintilimab pamwe chete nefruquintinib muvarwere vane kenza yemukati mechibereko avo vakamborwarazve, vakaenderera mberi nechirwere kana kuti vakabatwa nechirwere ichi nekurapwa ne platinum-based doublet chemotherapy. Mhedzisiro kubva kuFRUSICA-1 yakapihwa pamusangano wepagore weAmerican Society of Clinical Oncology muna Chikumi 2024.
AHuwandu hwemapts 98 ane mamiriro e pMMR vakanyoreswa uye vakagamuchira mushonga wakabatana. Mapts ese akambogamuchira kanenge mushonga wekutanga we platinum une systemic therapy, uye 22.4% mapts akagamuchira bevacizumab therapy. Nhoroondo dzakadzama dzechirwere dzakapfupikiswa mutafura. Nenguva yekutevera yepakati (95% CI) ye15.7m (14.6, 17.7), 87/98 mapts aive nekanenge kamwe chete mushure mekutanga kwekuongorora bundu (pts dzinoongororwa kushanda), pakati padzo, IRC-assessed ORR neDCR zvaive 35.6% (CR: 2/87 uye PR: 29/87) uye 88.5% zvichiteerana; DoR haina kusvikwa uye chiyero che9m-DoR chaive 80.7%. Pakati pemapoinzi 98, avhareji (95% CI) PFS neOS yaive 9.5m (5.6, -) uye 21.3m (17.3, -) zvichiteerana. Zvichienderana nekurapwa kwebevacizumab, ORR yaive 40.9% vs 30.3%, uye avhareji (95% CI) PFS yaive 13.8m (4.1, -) vs 9.5m (5.5, -).
Zviitiko zvakaipa zvinoenderana nezvakataurwa nezvekurapa kwakafanana kwe immunotherapy uye mishonga ye antiangiogenic.
NezveSintilimab
Sintilimab, inotengeswa seTYVYT (sintilimab injection) muChina, iPD-1 immunoglobulin G4 monoclonal antibody yakagadzirwa pamwe chete naInnovent naEli Lilly and Company. Sintilimab imhando yeimmunoglobulin G4 monoclonal antibody, iyo inosunga kumamorekuru ePD-1 pamusoro peT-cells, inovhara nzira yePD-1 / PD-Ligand 1 (PD-L1), uye inomutsazve T-cells kuti iuraye masero egomarara. MuChina, sintilimab yakatenderwa uye yakabatanidzwa muNRDL yakagadziridzwa yezviratidzo zvinomwe. NRDL reimbursement scope yakagadziridzwa yeTYVYT (sintilimab injection) inosanganisira:
Kurapa Hodgkin's lymphoma yakadzoka kana kuti isingadzoreki mushure mekurapwa kwemishonga yekurapa inouraya utachiona hwemuviri kaviri kana kupfuura;
Kurapa kwekutanga kwekenza yemapapu isina kenza yemapapu inopararira munharaunda kana kuti isina masero madiki asina EGFR kana ALK driver gene mutations;
Kurapa varwere vane kenza yemapapu isina squamous non-small cell cancer yakachinja mamiriro emunzvimbo kana kuti yakapararira mushure mekurapwa neEGFR-TKI;
Kurapa kenza yemapapu isina kubatwa zvakanaka munharaunda kana kuti kenza yemapapu isina masero madiki inopararira;
Kurapa kwekutanga kwekenza yeropa isingabvisike kana kuti yakapararira mumuviri pasina kurapwa kwakarongeka;
Kurapa kwekutanga kwekenza ye squamous cell carcinoma isingarapwe munharaunda, inodzokororwa kana kuti inopararira mumuviri;
Kurapa kwekutanga kweadenocarcinoma yemudumbu isingabvisike, inodzokororwa kana inopararira munzvimbo iyoyo.
Uyezve, chiratidzo chechisere chesintilimab, pamwe chete nefruquintinib yekurapa varwere vane kenza ye endometrial yepamusoro vane mapundu e pMMR avo vakakundikana kurapwa kwemuviri kare uye vasiri vanokodzera kuvhiyiwa kwekurapa kana radiation, chakatenderwa neNMPA muna Zvita 2024.
Pamusoro pezvo, zvidzidzo zviviri zvekiriniki zve sintilimab zvakazadzisa mhedzisiro yazvo huru:
Chidzidzo chechikamu chechipiri chekurapa sintilimab monotherapy senzira yechipiri yekurapa esophageal squamous cell carcinoma;
Chidzidzo chechikamu chechitatu chekurapa kwe sintilimab monotherapy senzira yechipiri yekurapa kenza yemapapu isina squamous non-small cell ine kufambira mberi kwechirwere mushure me chemotherapy yakagadzirwa neplatinum.
Nezve Fruquintinib
Fruquintinib mushonga unodzivirira masero ese matatu eropa endothelial growth factor (“VEGF”) receptors (VEGFR-1, -2 uye -3). VEGFR inhibitors inoita basa guru mukudzivirira angiogenesis yegomarara. Fruquintinib yakagadzirwa kuti ive nesarudzo yakawedzerwa inoganhurira kushanda kwekinase isina chinangwa, zvichibvumira kushandiswa kwemishonga inoita kuti pave nekudzikamiswa kwenguva refu uye kuchinjika kwekushandiswa sechikamu chekurapa kwakabatana.
Fruquintinib inotenderwa kutengeswa kwemishonga yekurapa varwere vane kenza yemukati medumbu avo vakambopiwa fluoropyrimidine, oxaliplatin uye irinotecan-based chemotherapy, uye avo vakambopiwa kana kuti vasina kukodzera kugamuchira mushonga we anti-VEGF kana mushonga we anti-epidermal growth factor receptor (“EGFR”) (RAS wild-type) muChina, uko yakagadzirwa pamwe chete uye inotengeswa pamwe chete neHUTCHMED naEli Lilly and Company pasi pezita rekuti ELUNATE. Yakaiswa muChina National Reimbursement Drug List (“NRDL”) muna Ndira 2020. Kubva payakatanga kuChina, varwere vanopfuura 100,000 vane kenza yemukati medumbu vakarapwa nefruquintinib.
Muna Zvita 2024, fruquintinib yakatenderwa neNMPA pamwe chete ne sintilimab yekurapa varwere vane kenza ye endometrial yepamusoro vane mapundu e pMMR avo vakambotadza kurapwa zvakanaka uye vasiri vanokwanisa kuvhiyiwa kana kupiswa nemwaranzi.
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/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
Nguva yekutumira: Zvita-16-2024