Iulii 2023:
Cibus et Administration medicamento accelerato approbationem dederunt glofitamab-gxbm (Columvi, Genentech, Inc.) pro relapso vel refractorio diffusione magna lymphoma B-cellula, non aliter determinata (DLBCL, NOS) vel magna lymphoma B-cellula (LBCL) orta. lymphoma follicularis, post duas vel plures lineas therapiae systemicae.
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.
Utens 2014 Lugano signis, Independens Review Committee inspexit ratem obiectivam responsionis (ORR) et durationem responsionis (DOR) ut instaret quomodo tractatio bene laboraverit. ORR erat 56% (95% CI: 47-65), et 43% hominum plena responsa dabant. Conventi secuti sunt medium inter 11.6 menses, medianus DOR praedictus est 18.4 menses (95% CI: 11.4, non aestimabilis). Kaplan-Meier aestimatio pro DOR post 9 menses fuit 68.5% (95% CI: 56.7, 80.3). Mediocris temporis spatium audiendi erat 42 dierum.
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.
Praeter lab verba, frequentissima CRS effectus sunt, dolor in musculis, articulis, epinyctidas, languor. Maxime Gradus 3 ad 4 lab inventiones (circiter 20%) erant guttae in comitum lymphocytarum, phosphate, neutrophili comitum, et fibrinogenorum, et in acido uric oriuntur.
Post singula 1,000 mg dosis obinutuzumab die 1 cycli 1 ad deplendum telam lymphoideae et lymphoidei B cellularum circulationem, glofitamab-gxbm datur ab infusione intravenosa secundum schedulam dosing: 2.5 mg ad diem 8 Cycli 1 et 10 mg in diei 15 Cycli I, tum 1 mg in Dies I cuiusque cycli subsequentis ad maximum cyclorum 30 . Longitudo cycli est 1 dierum. Ad plenam dosis informationem, vide informationes quae cum praescriptione fiunt.
Glofitamab-gxbm tantum dari debet ab operario medico qui ius instrumenta habet ad motus graves tractandos, sicut CRS. Propter CRS periculum, aegroti in valetudinario manere debent et per 24 horas post primum gradum dosis (2.5 mg diei 8 Cycli) et pro secundo gressu dosis (1 mg ad diem 10 mensis). Cycle 15) si quis gradus CRS cum dosi 1 mg fit. Aegroti qui CRS Gradus 2.5 vel superiores cum ultima infusione habuerunt, manere debent in hospitali proxime infusione et per 2 horas post factum est.
FDA Oncology Centrum Excellentiae Project Orbis instauravit, quae ad hoc studium faciendum adhibita erat. Proiecti Orbis sociis peregrinis viam dat medicinae oncologiae subiciendi simulque. Pro hac recognitione, FDA cum Swissmedic laboravit, quae ubi applicatio spectatur.
View full prescribing information for Columvi.
