اگست 2021: The Food and Drug Administration approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first cell-based gene therapy for multiple myeloma that has been approved by the FDA.
Idecabtagene vicleucel ایک جینیاتی طور پر انجینئرڈ آٹولوگس chimeric antigen receptor (CAR) T-cell ٹریٹمنٹ ہے جو B-cell maturation antigen (BCMA) کو نشانہ بناتا ہے۔ ہر خوراک مریض کے اپنے ٹی سیلز کے مطابق بنائی جاتی ہے ، جن کو کاٹا جاتا ہے ، جینیاتی طور پر تبدیل کیا جاتا ہے ، اور پھر مریض میں دوبارہ متعارف کرایا جاتا ہے۔
In a multicenter research, 127 patients with relapsed and refractory ایک سے زیادہ 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 72 فیصد (95 فیصد CI: 62 فیصد ، 81 فیصد) ، 28 فیصد CR شرح (95 فیصد CI 19 فیصد ، 38 فیصد) کے ساتھ تھا۔ کل 65 فیصد مریض جنہوں نے CR حاصل کیا کم از کم ایک سال تک اس میں رہے۔
کے لیے ایک باکسڈ وارننگ سائٹوکائن ریلیز سنڈروم (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 میں 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 سے 460 106 CAR- مثبت ٹی سیلز آئیڈیکابٹیجین ویکیول کے لیے تجویز کردہ خوراک کی حد ہے۔
حوالہ: https://www.fda.gov/
تفصیلات چیک کریں یہاں:
