Maererano nenhamba, varwere vane gomarara remudumbu vanorapwa muUnited States, Europe, neJapan vanowanzokurudzirwa kushandisa ramucirumab pamwe chete nemimwe mishonga kurapa gomarara remudumbu.
Iyo US Food and Drug Administration (FDA) yakazivisa muna Kubvumbi 21, 2014 kuti yakabvumidza Ramelicirumab (Ramucirumab), zita rerudzi rweCyramza, kurapwa kwevarwere vane gomarara remudumbu repamusoro kana adenocarcinoma ye gastroesophageal junction. . Ramolizumab is humanized monoclonal inotarisa antibody iyo inovhara zvakanyanya vascular endothelial kukura factor receptor 2 (VEGFR2) uye yakadzika angiogenesis-inoenderana nzira.
Mutungamiriri weFDA's Hematology and Oncology Products Division akati: “Kunyange zvazvo nhamba yegomarara remudumbu yakaderera muUnited States mumakore makumi mana adarika, varwere vanoda nzira itsva dzokurapa, kunyanya kana dzisingashandi pakurapa kwazvino,” "Remo Ludan Resistance isarudzo nyowani kune varwere vane gomarara remudumbu, iyo yakaratidza kunonoka kukura kwebundu uye kurebesa hupenyu hwemurwere. “
Anti-cancer nheyo yeramucirumab: Nekudzivisa kuwanda uye kutama kwemasero endothelial anopindirana neVEGF, inogona kutamba anti-tumor effect.
Mishonga yemakiriniki yakaratidza kuti ramucirumab inogona kuvandudza zvakanyanya kupona (mwedzi 5.2 vs. 3.8 mwedzi) uye kuwedzera kufambira mberi-kusununguka kwekusununguka (mwedzi 2.1 vs. 1.3 mwedzi) kana ichienzaniswa ne placebo.
Muedzo weRAINBOW phase III wakaratidza kuti ramoluzumab yakasanganiswa ne paclitaxel yakavandudza zvakanyanya median OS (9.6 mwedzi vs. 7.4 mwedzi), PFS (4.4 mwedzi vs. 2.8 mwedzi), uye ORR (28% vs 16%) kana ichienzaniswa ne placebo.
Kusanganiswa kwemishonga inorwisa-angiogenic ramucirumab uye docetaxel mumutsara wechipiri kurapwa kwepamusoro kana metastatic urothelial carcinoma kwakaunza mhedzisiro inovimbisa. Combination chemotherapy ne cisplatin ndiyo yakajairwa kurapwa kwegomarara redundiro, uye dzimwe nzira dzekurapa dzinogumira mushure mekunge kurapwa kwekutanga kwaenderera. Kuongororwa kwepakati pechikamu ichi 2 randomized muedzo wakaratidza kuti kurapa kwekubatanidza kwakawedzera zvakanyanya kufambira mberi-kusina kupona kusvika kumavhiki e22, nepo docetaxel chete yaingova mavhiki e10.4 chete.
Kuenzaniswa ne-single-agent docetaxel, docetaxel 75mg / m2 yakasanganiswa neramucirumab 10mg / Kg sechirongwa chechipiri chekurapa mushure meplatinum-based chemotherapy for stage IV isiri-diki kenza yemapapu inogona kuvandudza zvakanyanya varwere 'ORR, PFS uye OS. Mukana mukuru ndewekuti chirongwa chine mhedzisiro yakafanana pa squamous cell carcinoma uye isiri-squamous cell carcinoma, uye hapana maitiro asina kufungidzira akashata.
Migumisiro yekuedzwa yakaratidza kuti chiyero chekupindura chedocetaxel chakasanganiswa neboka reramucirumab chaive chakakwirira kudarika cheboka rimwe chete docetaxel (22.9% v vs. 13.6%); nepo maererano nekufambira mberi-kusina kupona, boka rekurapa uye boka rekutonga (Kune mwedzi 4.5, VS3 mwedzi); nguva yekupona kwepakati iboka rekurapa uye boka rekutonga (mwedzi 10.5 VS 9.1 mwedzi). Kupona kwese kwemamwe mapoka muboka rekutonga kunogona kureba (kusanganisira squamous cell carcinoma uye isiri-squamous cell carcinoma).
Iyo US FDA yakatendera mushonga mumwechete weRamucirumab (Ramucirumab, Cyramza, Eli Lilly neKambani) wepamusoro kana metastatic gastric uye esophagogastric adenocarcinoma inofambira mberi kuburikidza neplatinamu-based uye fluorouracil-based chemotherapy. Mvumo inobva paI4T-IE-JVBD, yemarudzi akawanda, yakawanda, isina kurongeka (2: 1), kaviri-mapofu akadzivirirwa kudzidza kwevarwere ve355 vakanyoresa. Chidzidzo chacho chakaratidza kuti kurarama kwepakati kwepakati kweboka rakanakisisa rekurapa rinotsigira ramolizumab chete raiva mwedzi 5.2: mwedzi 3.8 (P = 0.004). Kushandiswa kweramoluzumab ndeye 8 mg / kg intravenous infusion kwemaminitsi makumi matanhatu q60w. LANCET o nCOLGY 2 yakaburitsa mhedzisiro yeREGARD Phase III yekiriniki yekudzidza online. Mune metastatic gastric kana gastroesophageal junction (GEJ) adenocarcinoma iyo yakafambira mberi mushure mekutanga kurapwa, Ramucirumab (RAM, IMC-20131011B) iripo kana ichienzaniswa ne placebo. Kune zviverengero zvakakosha OS uye PFS mabhenefiti, uye chengetedzo inogamuchirwa.
Ramolizumab inonyanya kurapa zvirwere
Metastatic urethral epithelial cancer, cancer yemapapu, advanced or metastatic adenocarcinoma yemudumbu uye esophagogastric junction.
Zvinowanzoitika mhedzisiro yeRamucumab
Izvo zvinowanzoitika zvakashata ndezvekuti: hypertension, anemia, kurwadziwa mudumbu, ascites, kuneta, kurasikirwa kwechido uye hyponatremia.
Ramolizumab inogadzirwa naEli Lilly neKambani yekuUnited States, uye mushonga uyu uchatengeswa pasi pezita rechiratidzo Cyramza. Eli Lilly ane muzinda muIndianapolis, Indiana, USA.
Muna 2014, US FDA yakabvumira CYRAMZA (ramucirumab) jekiseni rekurapa zvirwere pamwe chete nemimwe mishonga. Cyramza mushonga mutsva wakaratidza kurebesa hupenyu hwemurwere uye kunonoka kukura kwebundu. Inopa sarudzo nyowani dzevarwere vegomarara nevarapi. Zvisinei, maererano nemaitiro apfuura, mushonga uyu haugone kutengeswa munyika yeChina munguva pfupi. Zvinoenderana nehuwandu hwazvino, hapana mushonga wakatengeswa muChina mukati memakore manomwe emvumo yeFDA. Imwezve data ine hutsinye ndeyekuti varwere vegomarara vakakura kusvika pakati pepamusoro nekukurumidza pavanowanikwa. Kurarama kwemakore mashanu kwevarwere vane gomarara remudumbu repamusoro kunongova 5% -40%, uye makore mashanu ekupona kwepakati-yepamusoro cancer cancer i50% chete. Iyo 5-gore yekupona nguva zvakare iri pasi pe44%. Izvi zvinoreva kuti ruzhinji rwevarwere havagone kumirira Ramucirumab Cyramza.