2021 Agustus: Administrasi Pangan sareng Narkoba disatujuan idecabtagene vicleucel (Abecma, Bristol Myers Squibb) pikeun pengobatan pasien dewasa sareng sababaraha myeloma kambuh atanapi refractory saatos opat atanapi langkung jalur terapi sateuacana, kalebet agén immunomodulatory, inhibitor proteasome, sareng anti CD38. antibodi monoklonal. Ieu mangrupikeun terapi gén dumasar sél munggaran pikeun sababaraha myeloma anu parantos disatujuan ku FDA.
Idecabtagene vicleucel nyaéta rékayasa genetik autologous chimeric antigen reséptor (CAR) perlakuan T-sél nu nargétkeun B-sél maturation antigen (BCMA). Masing-masing dosis disaluyukeun kana sél-T pasien sorangan, anu dipanén, dirobih sacara genetik, teras diwanohkeun deui ka pasien.
In a multicenter research, 127 patients with relapsed and refractory sababaraha myeloma who had undergone at least three prior lines of antimyeloma therapy were evaluated for safety and efficacy; 88 percent had received four or more prior lines of therapies. The efficacy of idecabtagene vicleucel at doses ranging from 300 to 460 x 106 CAR-positive T cells was studied in 100 individuals. The overall response rate (ORR), complete response (CR) rate, and duration of response (DOR) were calculated using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma by an independent response committee.
ORR éta 72 persén (95 persén CI: 62 persén, 81 persén), kalayan tingkat CR 28 persén (95 persén CI 19 persén, 38 persén). Sajumlah 65 persén pasien anu ngahontal CR cicing di jerona sahenteuna sataun.
A warning boxed pikeun Sindrom pelepasan sitokin (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and persistent cytopenias is included on the idecabtagene vicleucel label. CRS, infections, exhaustion, musculoskeletal pain, and hypogammaglobulinemia are the most prevalent side effects of idecabtagene vicleucel.
Idecabtagene vicleucel has a risk evaluation and mitigation plan that requires healthcare facilities dispensing the medicine to be specially certified in recognising and managing CRS and nervous system toxicities. The FDA is ordering the company to conduct a post-marketing observational study involving patients treated with idecabtagene vicleucel in order to assess long-term safety.
300 dugi 460 106 sél T positip-CAR nyaéta kisaran dosis anu disarankeun pikeun idecabtagene vicleucel.
Rujukan: https://www.fda.gov/
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