Julayi 2023:
I-Food and Drug Administration inikeze imvume esheshayo ku-glofitamab-gxbm (Columvi, Genentech, Inc.) yokusabalalisa kabusha i-B-cell lymphoma enkulu, engashiwongo ngenye indlela (i-DLBCL, i-NOS) noma i-B-cell lymphoma (LBCL) enkulu evela ku-follicular lymphoma, ngemva kwemigqa emibili noma ngaphezulu ye-systemic yokwelapha.
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 i-lymphoma. 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.
Isebenzisa amazinga e-Lugano ka-2014, IKomidi Lokubuyekeza Elizimele libheke izinga lokuphendula lenhloso (ORR) kanye nobude besikhathi sokuphendula (DOR) ukuze lithole ukuthi ukwelashwa kusebenze kahle kangakanani. I-ORR yayingama-56% (95% CI: 47–65), kanti u-43% wabantu unikeze izimpendulo ezigcwele. Abaphendulile balandelelwa ngokwesilinganiso sezinyanga eziyi-11.6, ngakho-ke i-DOR emaphakathi yabikezelwa ukuthi iyizinyanga eziyi-18.4 (95% CI: 11.4, ayilinganiseki). Isilinganiso sika-Kaplan-Meier se-DOR ngemva kwezinyanga ezingu-9 sasingu-68.5% (95% CI: 56.7, 80.3). Isilinganiso senani lesikhathi sokulalela kwakuyizinsuku ezingama-42.
There is a Boxed Warning about i-cytokine release 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.
Ngaphandle kwamagama zelebhu, imiphumela emibi evame kakhulu kwakuyi-CRS, ubuhlungu emisipha nasemalungeni, ukuqubuka, nokukhathala. Okuningi okutholwe ilebhu yeBanga lesi-3 kuya kwelesi-4 (cishe amaphesenti angama-20) kwakuwukwehla kwezibalo ze-lymphocyte, i-phosphate, izibalo ze-neutrophil, ne-fibrinogen, nokukhuphuka kwe-uric acid.
Ngemuva komthamo owodwa we-1,000 mg we-obinutuzumab ngosuku loku-1 loMjikelezo 1 wokuqeda amaseli ezicubu ze-lymphoid B, i-glofitamab-gxbm inikezwa ngokufakwa emthanjeni ngokuya ngeshejuli yomthamo okhuphukayo: 2.5 mg ngosuku lwe-8 lomjikelezo woku-1 kanye no-10 mg we-Cycle 15 yomjikelezo woSuku 1 isiqephu ngasinye sosuku loku-30, bese kuba ngu-1. ubuningi bemijikelezo eyi-12. Ubude bomjikelezo yizinsuku ezingama-21. Ukuze uthole ulwazi olugcwele lwethamo, bheka ulwazi oluza nencwadi kadokotela.
I-Glofitamab-gxbm kufanele inikezwe kuphela umsebenzi wezokwelapha onamathuluzi afanele okusingatha ukusabela okunzima, njenge-CRS. Ngenxa yobungozi be-CRS, iziguli kufanele zihlale esibhedlela phakathi namahora angama-24 ngemuva komthamo wokuqala wokwenyusa (2.5 mg Ngosuku 8 Lomjikelezo 1) kanye nethamo lesibili lokukhuphuka (10 mg NgoSuku 15 Lomjikelezo Woku-1) uma kwenzeka noma iyiphi i-CRS yebanga ngomthamo ongu-2.5 mg. Iziguli ezazine-CRS yeBanga lesi-2 noma ngaphezulu ngokumnika kwazo okokugcina kufanele zihlale esibhedlela ngesikhathi sokumnika okulandelayo namahora angu-24 ngemva kwalokho.
I-FDA Oncology Centre of Excellence yasungula i-Project Orbis, eyasetshenziswa ukwenza lolu cwaningo. I-Project Orbis inikeza ozakwethu bakwamanye amazwe indlela yokuthumela nokubuyekeza izidakamizwa ze-oncology ngesikhathi esifanayo. Kulokhu kubuyekezwa, i-FDA isebenze ne-Swissmedic, yilapho isicelo sibhekwa khona.
View full prescribing information for Columvi.
