Luulyo 2023:
Maamulka Cuntada iyo Dawooyinka ayaa siisay ogolaansho degdeg ah glofitamab-gxbm (Columvi, Genentech, Inc.) dib u soo noqoshada ama dib u soo celinta lymphoma weyn ee B-cell, aan si kale loo cayimin (DLBCL, NOS) ama B-cell lymphoma (LBCL) weyn oo ka soo jeeda follicular lymphoma, ka dib laba ama in ka badan oo daawaynta habdhiska.
Glofitamab-gxbm, which is a bispecific CD20-directed CD3 T-cell engager, was studied in study NP30179 (NCT03075696), which was an open-label, single-arm, multicenter trial with 132 patients to test its effectiveness. Eighty percent of the patients had DLBCL, NOS that had come back or didn’t respond to treatment, and 20% had LBCL that came from follicular qanjiro. At least two lines of systemic treatment had been used before (median 3, range 2–7). Patients with current or past diseases or lymphomas of the central nervous system were not allowed to take part in the trial.
Iyadoo la adeegsanayo heerarka Lugano 2014, Guddiga Dib u Eegista Madaxbanaan waxay eegay heerka jawaabta ujeedada (ORR) iyo muddada jawaabta (DOR) si ay u ogaadaan sida wanaagsan ee daaweyntu u shaqeyso. ORR wuxuu ahaa 56% (95% CI: 47-65), iyo 43% dadku waxay bixiyeen jawaabo buuxa. Jawaab bixiyaasha ayaa la raacay celcelis ahaan bilaha 11.6, markaa dhexdhexaadka DOR ayaa la saadaaliyay inuu yahay bilaha 18.4 (95% CI: 11.4, lama qiyaasi karo). Qiyaasta Kaplan-Meier ee DOR 9 bilood ka dib waxay ahayd 68.5% (95% CI: 56.7, 80.3). Celceliska wakhtiga dib loo maqlo waxay ahayd 42 maalmood.
There is a Boxed Warning about cytokine sii daayo syndrome (CRS), which can be very dangerous or even kill you. Other Warnings and Precautions include neurotoxicity, such as Immune Effector Cell-Associated Neurotoxicity (ICANS), major infections, and tumour flare. When the safety of 145 people with relapsed or refractory LBCL was looked at, 70% had CRS (Grade 3 or higher CRS, 4.1%), 4.8% had ICANS, 16% had major infections, and 12% had their tumours get worse.
Marka laga reebo ereyada shaybaadhka, dhibaatooyinka ugu badan ee soo raaca waxay ahaayeen CRS, xanuun muruqyada iyo kala-goysyada, finan, iyo daal. Inta badan natiijooyinka 3 ilaa 4 ee shaybaadhka (qiyaastii 20%) ayaa hoos u dhacay tirooyinka lymphocyte, fosfat, tirinta neutrophils, iyo fibrinogen, oo waxay ku kacdaa uric acid.
Ka dib hal 1,000 mg dose of obinutuzumab maalinta 1 ee wareegga 1 si ay u baabi'iso wareegga wareegga iyo unugyada lymphoid B unugyada, glofitamab-gxbm waxaa la siiyaa faleebo xididka iyada oo loo eegayo jadwalka qiyaasta kor u qaadista: 2.5 mg maalinta 8 ee wareegga 1 iyo 10 mg maalintii wareegga 15 ee maalin kasta ee Cycle 1. ugu badnaan 30 wareeg. Dhererka wareeggu waa 1 maalmood. Si aad u hesho xog buuxda, eeg macluumaadka la socda rijeetada.
Glofitamab-gxbm waa in uu bixiyaa kaliya shaqaale caafimaad kaas oo haysta qalabka saxda ah si uu wax uga qabto falcelinta daran, sida CRS. Khatarta CRS awgeed, bukaanadu waa inay joogaan cusbitaalka inta lagu jiro iyo saacadaha 24 ka dib qiyaasta kor u qaadista koowaad (2.5 mg maalinta 8 ee wareegga 1) iyo qiyaasta labaad ee kor u qaadista (10 mg maalinta 15 ee wareegga 1) haddii darajo kasta CRS ay ku dhacdo qiyaasta 2.5 mg. Bukaannada qabay CRS ee Fasalka 2 ama ka sare ee faleebooyinkoodii ugu dambeeyay waa inay joogaan cusbitaalka inta lagu jiro faleebada soo socota iyo 24 saacadood ka dib marka la sameeyo.
Xarunta Sare ee Oncology ee FDA waxay dejisay Project Orbis, kaas oo loo isticmaalay in lagu sameeyo daraasaddan. Mashruuca Orbis wuxuu siinayaa la-hawlgalayaasha ajnabiga ah hab ay ku soo gudbiyaan oo ay dib u eegaan daawooyinka kansarka isla waqti isku mid ah. Dib u eegistaan, FDA waxay la shaqeysay Swissmedic, taas oo ah meesha codsiga laga eegayo.
View full prescribing information for Columvi.
