Yuli 2023:
Cibiyar Abinci da Drug ta ba da izini ga glofitamab-gxbm (Columvi, Genentech, Inc.) don sake dawowa ko refractory yaduwa babban lymphoma B-cell, ba a kayyade ba (DLBCL, NOS) ko babban lymphoma B-cell (LBCL) wanda ya taso daga follicular lymphoma, bayan biyu ko fiye da layi na tsarin tsarin.
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 linzoma. 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.
Yin amfani da ka'idojin Lugano na 2014, Kwamitin Bincike mai zaman kansa ya kalli ƙimar amsawar haƙiƙa (ORR) da tsawon lokacin amsawa (DOR) don gano yadda aikin ya yi aiki sosai. ORR ya kasance 56% (95% CI: 47-65), kuma 43% na mutane sun ba da cikakkun amsoshi. An bi diddigin masu amsawa na matsakaicin watanni na 11.6, don haka ana hasashen matsakaicin DOR zai zama watanni 18.4 (95% CI: 11.4, ba ƙima ba). Kiyasin Kaplan-Meier na DOR bayan watanni 9 shine 68.5% (95% CI: 56.7, 80.3). Matsakaicin adadin lokacin jin baya shine kwanaki 42.
There is a Boxed Warning about cytokine saki ciwo (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.
Baya ga kalmomin dakin gwaje-gwaje, illolin da aka fi sani sune CRS, zafi a cikin tsokoki da haɗin gwiwa, rashes, da gajiya. Yawancin binciken bincike na Grade 3 zuwa 4 (kimanin kashi 20%) sun ragu a cikin ƙididdigar lymphocyte, phosphate, neutrophil Counts, da fibrinogen, kuma yana tashi a cikin uric acid.
Bayan guda 1,000 MG na obinutuzumab a ranar 1 na Cycle 1 don rage rarrabawar ƙwayoyin cuta da ƙwayoyin lymphoid B, ana ba da glofitamab-gxbm ta hanyar jiko na ciki bisa ga tsarin ƙaddamarwa na mataki: 2.5 MG a ranar 8 na Cycle 1 da 10 MG a rana ta 15 na Cycle 1 da 30 MG a kan Rana 1 na Cycle 12 MG. matsakaicin zagayowar 21. Tsawon zagayowar shine kwanaki XNUMX. Don cikakken bayanin kashi, duba bayanin da ya zo tare da takardar sayan magani.
Glofitamab-gxbm ya kamata ma'aikacin likita ne kawai ya ba da kayan aikin da suka dace don magance mummunan halayen, kamar CRS. Saboda hadarin CRS, marasa lafiya ya kamata su kasance a asibiti a lokacin da kuma na tsawon sa'o'i 24 bayan matakin farko na farko (2.5 MG a ranar 8 na Cycle 1) kuma don kashi na biyu na mataki na biyu (10 MG a ranar 15 na Cycle 1) idan kowane CRS ya faru tare da kashi na 2.5 MG. Marasa lafiya waɗanda ke da CRS na Grade 2 ko mafi girma tare da jiko na ƙarshe yakamata su kasance a asibiti yayin jiko na gaba kuma na awanni 24 bayan an gama.
Cibiyar Nazarin Oncology ta FDA ta kafa Orbis Project, wanda aka yi amfani da shi don yin wannan binciken. Project Orbis yana ba abokan hulɗar ƙasashen waje hanya don ƙaddamarwa da sake nazarin magungunan oncology a lokaci guda. Don wannan bita, FDA ta yi aiki tare da Swissmedic, wanda shine inda ake duba aikace-aikacen.
View full prescribing information for Columvi.
