Ngokwezibalo, iziguli ezinomdlavuza wesisu ezelashwa e-United States, eYurophu naseJapane ngokuvamile zituswa ukuba zisebenzise i-ramucirumab kanye neminye imithi yokwelapha umdlavuza wesisu.
I-US Food and Drug Administration (FDA) yamemezela ngo-Ephreli 21, 2014 ukuthi igunyaze i-Ramelicirumab (Ramucirumab), igama lomkhiqizo we-Cyramza, yokwelapha iziguli ezinomdlavuza wesisu othuthukisiwe noma i-adenocarcinoma ye-gastroesophageal junction. . I-Ramolizumab iyi-antibody eqondiswe ngumuntu ye-monoclonal evimba ngokukhethekile i-vascular endothelial growth factor receptor 2 (VEGFR2) kanye nezindlela ezihlobene ne-angiogenesis ezansi nomfula.
Umqondisi we-FDA's Hematology and Oncology Products Division wathi: “Nakuba izinga lomdlavuza wesisu liye lehla e-United States phakathi neminyaka engamashumi amane edlule, iziguli zidinga izindlela ezintsha zokwelapha, ikakhulukazi lapho zingasebenzi ekwelashweni kwamanje,” “I-Remo Ludan Resistance iyindlela entsha ekhethwa ezigulini ezinomdlavuza wesisu, okukhonjiswe ukuthi ibambezela ukukhula kwesimila futhi yelule impilo yesiguli. “
Umgomo wokulwa nomdlavuza we-ramucirumab: Ngokuvimbela ukwanda nokufuduka kwamaseli e-endothelial alamula i-VEGF, ingadlala umphumela wokulwa nesimila.
Ukuhlolwa kwemitholampilo kubonise ukuthi i-ramucirumab ingathuthukisa kakhulu ukusinda (izinyanga ezingu-5.2 vs. 3.8 izinyanga) futhi yandise ukusinda kokungena okuqhubekayo (izinyanga ezingu-2.1 vs. 1.3 izinyanga) uma kuqhathaniswa ne-placebo.
Ukuhlolwa kwesigaba III se-RAINBOW kubonise ukuthi i-ramoluzumab ehlanganiswe ne-paclitaxel ithuthukise kakhulu i-OS ephakathi (izinyanga ezingu-9.6 vs. 7.4 izinyanga), i-PFS (izinyanga ezingu-4.4 vs. 2.8 izinyanga), kanye ne-ORR (28% vs 16%) uma kuqhathaniswa ne-placebo.
Inhlanganisela yomuthi olwa ne-angiogenic ramucirumab kanye ne-docetaxel ekwelashweni komugqa wesibili we-Advanced or Metastatic urothelial carcinoma iveze imiphumela ethembisa kakhulu. Inhlanganisela yokwelapha ngamakhemikhali ne-cisplatin iwukwelashwa okujwayelekile komdlavuza wesinye we-metastatic, futhi ezinye izinketho zokwelapha zinomkhawulo ngemva kokuqhubeka kokwelashwa komugqa wokuqala. Ukuhlaziywa kwamaphakathi kwethemu kwalesi sigaba sesi-2 sokuhlola okungahleliwe kubonise ukuthi ukwelashwa okuhlangene kwandise kakhulu ukusinda okungaqhubeki kwaba ngamaviki angu-22, kuyilapho i-docetaxel iyodwa yayingamaviki angu-10.4 kuphela.
Uma kuqhathaniswa ne-docetaxel ye-ejenti eyodwa, i-docetaxel 75mg / m2 ehlanganiswe ne-ramucirumab 10mg / Kg njengohlelo lokwelapha lomugqa wesibili ngemva kokwelashwa ngamakhemikhali okusekelwe ku-platinum yesigaba IV umdlavuza wamaphaphu ongewona omncane ungathuthukisa kakhulu i-ORR, PFS ne-OS yeziguli. Inzuzo enkulu ukuthi uhlelo lunomthelela ofanayo obalulekile ku-squamous cell carcinoma kanye ne-non-squamous cell carcinoma, futhi akukho ukusabela okubi okungalindelekile.
Imiphumela yocwaningo ibonise ukuthi izinga lokuphendula eliphelele le-docetaxel elihlanganiswe neqembu le-ramucirumab laliphezulu kakhulu kuneqembu le-docetaxel le-ejenti eyodwa (22.9% v vs. 13.6%); kuyilapho ngokuphathelene nokuphila kwamahhala kokuqhubekela phambili, iqembu lokwelapha kanye neqembu lokulawula (Kunezinyanga ezingu-4.5, izinyanga ze-VS3); isikhathi sokusinda esimaphakathi yiqembu lokwelapha kanye neqembu elilawulayo (izinyanga eziyi-10.5 VS izinyanga eziyi-9.1). Ukusinda sekukonke kwamanye amaqoqo amancane eqenjini lokulawula kungaba isikhathi eside (okuhlanganisa i-squamous cell carcinoma kanye ne-non-squamous cell carcinoma).
I-FDA yase-US igunyaze umuthi owodwa we-Ramucirumab (i-Ramucirumab, i-Cyramza, i-Eli Lilly neNkampani) ye-Advanced or metastatic gastric and esophagogastric adenocarcinoma eqhubeka nge-platinum-based and fluorouracil-based chemotherapy. Ukugunyazwa kusekelwe ku-I4T-IE-JVBD, i-multinational, multicenter, randomized (2: 1), isifundo esilawulwa kabili esiyimpumputhe seziguli ze-355 ezibhalisiwe. Ucwaningo lubonise ukuthi ukusinda okuphelele okumaphakathi kweqembu elingcono kakhulu lokwelapha elisekela nge-ramolizumab kuphela kwakuyizinyanga ezingu-5.2: izinyanga ezingu-3.8 (P = 0.004). Ukusetshenziswa kwe-ramoluzumab ngu-8 mg/kg ngokufakwa emthanjeni imizuzu engama-60 q2w. I-LANCET o nCOLGY 20131011 ishicilele imiphumela yocwaningo lomtholampilo lwe-REGARD Phase III ku-inthanethi. Ku-metastatic gastric or gastroesophageal junction (GEJ) i-adenocarcinoma eye yathuthuka ngemva kokwelashwa komugqa wokuqala, i-Ramucirumab (RAM, IMC-1121B) ikhona uma iqhathaniswa ne-placebo. Kunezinzuzo zezibalo ezibalulekile ze-OS ne-PFS, futhi ukuphepha kwamukelekile.
I-Ramolizumab yelapha izifo ikakhulukazi
Umdlavuza we-Metastatic urethral epithelial, umdlavuza wamaphaphu, i-adenocarcinoma ethuthukisiwe noma ye-metastatic yesisu kanye ne-esophagogastric junction.
Imiphumela emibi evamile ye-Ramucumab
Ukusabela okungekuhle okuvame kakhulu yilezi: umfutho wegazi ophakeme, i-anemia, ubuhlungu besisu, ama-ascites, ukukhathala, ukuphelelwa isifiso sokudla kanye ne-hyponatremia.
I-Ramolizumab ikhiqizwa ngu-Eli Lilly and Company yase-United States, kanti umuthi uzomakethwa ngaphansi kwegama lomkhiqizo i-Cyramza. U-Eli Lilly uyindlunkulu e-Indianapolis, e-Indiana, e-USA.
Ngo-2014, i-US FDA yagunyaza umjovo we-CYRAMZA (ramucirumab) womjovo wokwelapha izifo ngokuhlanganiswa nezinye izidakamizwa. I-Cyramza umuthi omusha okhonjiswe ukuthi welula impilo yesiguli futhi ubambezela ukukhula kwesimila. Inikeza izinketho ezintsha zeziguli ezinomdlavuza kanye nabelaphi. Kodwa-ke, ngokusho komkhuba odlule, lesi sidakamizwa asikwazi ukuthengiswa ezweni laseChina ngesikhathi esifushane. Ngokwezibalo zamanje, awukho umuthi osemakethe e-China phakathi neminyaka eyisikhombisa yokugunyazwa yi-FDA. Enye imininingwane enonya ukuthi iziguli ezinomdlavuza ziye zakhula zaba maphakathi ngokushesha lapho zitholwa. Ukusinda kweminyaka emi-5 kweziguli ezinomdlavuza wesisu osuthuthukile kungama-40% -50% kuphela, kanti izinga lokusinda leminyaka emihlanu lomdlavuza we-colorectal ophakathi nendawo lingama-5 kuphela%. Isikhathi sokuphila seminyaka emi-44 naso singaphansi kwama-5%. Lokhu kusho ukuthi iningi leziguli alikwazi ukulinda i-Ramucirumab Cyramza.
