Iyul: 2023:
Oziq-ovqat va farmatsevtika ma'muriyati glofitamab-gxbm (Columvi, Genentech, Inc.) ga ikki yoki undan ortiq follikulyar tizimlardan keyin paydo bo'ladigan, boshqacha ko'rsatilmagan (DLBCL, NOS) yoki katta B hujayrali limfoma (LBCL) relapsli yoki refrakter diffuz katta B hujayrali limfoma uchun tezlashtirilgan ruxsat berdi.
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 limfoma. 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.
2014 yilgi Lugano standartlaridan foydalangan holda, Mustaqil Ko'rib chiqish qo'mitasi davolanish qanchalik yaxshi ishlaganligini aniqlash uchun ob'ektiv javob tezligi (ORR) va javob davomiyligini (DOR) ko'rib chiqdi. ORR 56% (95% CI: 47-65) ni tashkil etdi va 43% odamlar to'liq javob berdi. Respondentlar o'rtacha 11.6 oy davomida kuzatilgan, shuning uchun o'rtacha DOR 18.4 oy bo'lishi bashorat qilingan (95% CI: 11.4, baholanmaydi). Kaplan-Meyerning 9 oydan keyin DOR uchun taxmini 68.5% (95% CI: 56.7, 80.3) edi. Eshitish uchun o'rtacha vaqt 42 kun edi.
There is a Boxed Warning about sitokinlarni chiqarish sindromi (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.
Laboratoriya so'zlaridan tashqari, eng ko'p uchraydigan yon ta'sirlar CRS, mushaklar va bo'g'imlardagi og'riqlar, toshmalar va charchoq edi. 3-4-darajali laboratoriya natijalarining aksariyati (taxminan 20%) limfotsitlar, fosfatlar, neytrofillar va fibrinogen miqdorining pasayishi va siydik kislotasining ko'tarilishi edi.
Aylanma va limfoid to'qimalarning B hujayralarini yo'q qilish uchun 1,000-siklning 1-kunida obinutuzumabning bir martalik 1 mg dozasidan so'ng, glofitamab-gxbm vena ichiga infuzion dozani oshiruvchi sxema bo'yicha yuboriladi: siklning 2.5-kuni 8 mg va 1-kuni 10 mg, so'ngra har 15-kuni 1 mg C30 maksimal 1 tsikl uchun ent tsikli. Tsiklning davomiyligi 12 kun. To'liq doza haqida ma'lumot olish uchun retsept bilan birga keladigan ma'lumotga qarang.
Glofitamab-gxbm faqat CRS kabi og'ir reaktsiyalar bilan kurashish uchun kerakli vositalarga ega bo'lgan tibbiyot xodimi tomonidan berilishi kerak. CRS xavfi tufayli bemorlar birinchi dozani oshirgandan keyin (24-siklning 2.5-kunida 8 mg) va agar 1 mg dozada CRS darajasi yuzaga kelsa, ikkinchi oshirilgan dozada (10-siklning 15-kunida 1 mg) bemorlar shifoxonada qolishlari kerak. Oxirgi infuzionda CRS 2.5 yoki undan yuqori darajaga ega bo'lgan bemorlar keyingi infuziya paytida va u tugaganidan keyin 2 soat davomida kasalxonada qolishlari kerak.
FDA Onkologiya Mukammallik Markazi ushbu tadqiqot uchun foydalanilgan Project Orbisni yaratdi. Orbis loyihasi xorijiy hamkorlarga bir vaqtning o'zida onkologik dori-darmonlarni topshirish va ko'rib chiqish yo'lini beradi. Ushbu ko'rib chiqish uchun FDA Swissmedic bilan ishladi, bu erda ariza ko'rib chiqilmoqda.
View full prescribing information for Columvi.
