July 2023:
Food and Drug Administration yakapa kukurumidza kubvumidza glofitamab-gxbm (Columvi, Genentech, Inc.) yekudzokororwa kana refractory diffuse hombe B-cell lymphoma, isina kutaurwa neimwe nzira (DLBCL, NOS) kana hombe B-cell lymphoma (LBCL) ichibva kufollicular lymphoma, mushure memitsara miviri kana kupfuura yesystemic therapy.
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 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.
Ichishandisa zviyero zveLugano zve2014, Komiti Yakazvimirira Yokuongorora yakatarisa chiyero chekupindura chinangwa (ORR) uye nguva yekupindura (DOR) kuti ione kuti kurapwa kwakashanda sei. ORR yaive 56% (95% CI: 47–65), uye 43% yevanhu vakapa mhinduro dzakakwana. Vakapindura vakateverwa kune avhareji yemwedzi ye11.6, saka yepakati DOR yakafanotaurwa kuva 18.4 mwedzi (95% CI: 11.4, isingafungidzirwe). Kaplan-Meier's estimate yeDOR mushure memwedzi ye9 yaive 68.5% (95% CI: 56.7, 80.3). Avhareji yenguva yekunzwa mhinduro yaive mazuva makumi mana nemaviri.
There is a Boxed Warning about 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.
Kunze kwemazwi erabhu, iwo ainyanyozivikanwa mhedzisiro yaive CRS, kurwadziwa mumamhasuru nemajoini, mapundu, uye kuneta. Zvizhinji zveGrade 3 kusvika 4 lab zvakawanikwa (zvinenge 20%) zvaive madonhwe e lymphocyte count, phosphate, neutrophil counts, uye fibrinogen, uye inokwira muuric acid.
Mushure meimwe 1,000 mg dose ye obinutuzumab paZuva 1 reCycle 1 kuti ipedze kutenderera uye lymphoid tissue B masero, glofitamab-gxbm inopiwa ne intravenous infusion maererano nedanho-up dosing purogiramu: 2.5 mg paZuva 8 reCycle 1 uye 10 mg Cycle 15 yeZuva 1 MG paZuva 30 rimwe nerimwe zuva 1 huwandu hwe12 cycles. Kureba kwekutenderera mazuva makumi maviri nerimwe. Kuti uwane ruzivo rwakazara rwedosi, tarisa ruzivo rwunouya nemishonga.
Glofitamab-gxbm inofanirwa kupihwa chete nemushandi wekurapa ane maturusi akakodzera ekubata maitiro akanyanya, seCRS. Nekuda kwenjodzi yeCRS, varwere vanofanirwa kugara muchipatara panguva uye kwemaawa makumi maviri nemana mushure mekutanga nhanho-up dose (24 mg paZuva 2.5 reCycle 8) uye yechipiri nhanho-up dose (1 mg paZuva 10 reCycle 15) kana chero giredhi CRS ikaitika neiyo 1 mg dose. Varwere vaive neCRS yeGiredhi 2.5 kana yepamusoro neiyo yavo yekupedzisira infusion vanofanirwa kugara muchipatara panguva inotevera infusion uye kwemaawa makumi maviri nemana mushure mekunge yaitwa.
Iyo FDA Oncology Center of Excellence yakamisa Project Orbis, iyo yakashandiswa kuita chidzidzo ichi. Project Orbis inopa vadyidzani vekune dzimwe nyika nzira yekuendesa uye kuongorora oncology mishonga panguva imwe chete. Kune ongororo iyi, iyo FDA yakashanda neSwissmedic, kunova ndiko kuri kutariswa chikumbiro.
View full prescribing information for Columvi.
