ኦገስት 2021: የምግብ እና የመድሀኒት አስተዳደር አይዲካባታጂን ቪኪሉሴል (አቤክማ፣ ብሪስቶል ማየርስ ስኩዊብ) ከአራት ወይም ከዚያ በላይ ቀደም ባሉት የሕክምና መስመሮች ከበሽታው ያገረሸባቸው ወይም የሚከለክሉ ብዙ myeloma ላላቸው አዋቂ ታካሚዎች ሕክምና ለመስጠት አጽድቋል፣ ይህም የበሽታ መከላከያ ወኪልን፣ ፕሮቲሶም ተከላካይ እና ፀረ-CD38ን ጨምሮ። ሞኖክሎናል ፀረ እንግዳ አካላት. ይህ ለብዙ myeloma በኤፍዲኤ ተቀባይነት ያገኘ የመጀመሪያው ሕዋስ ላይ የተመሠረተ የጂን ሕክምና ነው።
Idecabtagene vicleucel የ B-cell maturation antigen (BCMA) ላይ ያነጣጠረ በዘረመል ምህንድስና አውቶሎጅ ቺሜሪክ አንቲጂን ተቀባይ (CAR) ቲ-ሴል ሕክምና ነው። እያንዳንዱ መጠን ለታካሚው ቲ-ሴሎች የተዘጋጀ ነው, እነሱም ተሰብስበዋል, በጄኔቲክ ተሻሽለው እና ከዚያም እንደገና ወደ በሽተኛው ይተዋወቃሉ.
In a multicenter research, 127 patients with relapsed and refractory በርካታ እቴሎማ 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.
ኦርአር 72 በመቶ (95 በመቶ CI - 62 በመቶ ፣ 81 በመቶ) ፣ በ 28 በመቶ CR (95 በመቶ CI 19 በመቶ ፣ 38 በመቶ) ነበር። CR ን ያገኙ ሕመምተኞች በአጠቃላይ 65 በመቶ የሚሆኑት ቢያንስ ለአንድ ዓመት ያህል ቆይተዋል።
የቦክስ ማስጠንቀቂያ ለ ሳይቶኪን መልቀቂያ ሲንድሮም (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.
ከ 300 እስከ 460 106 CAR- አዎንታዊ ቲ ሴሎች ለ idecabtagene vicleucel የተጠቆመው የመጠን ክልል ነው።
ማጣቀሻ https://www.fda.gov/
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