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¨ç FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma (FDA, 2021.03.27.)
¨è Package Insert – Abecma
¨é ClinicalTrials.gov (NCT03361748)
Á¦Ç°¸í (¼ººÐ¸í) | Abecma (idecabtagene vicleucel) |
Çã°¡±ÇÀÚ | Celgene Corporation (Bristol Myers Squibb company) |
Çã°¡ÀÏ | 2021.3.26. (FDA) |
ÀûÀÀÁõ | • ÃÖ¼ÒÇÑ 4ȸ¿¡ °ÉÃÄ ´Ù¸¥ À¯Çü(immunomodulatory agent, proteasome inhibitor, anti-CD38 monoclonal antibody Æ÷ÇÔ)ÀÇ Ä¡·áÁ¦¿¡ ¹ÝÀÀÇÏÁö ¾Ê¾Ò°Å³ª Àç¹ßÇÑ ¼ºÀÎ ´Ù¹ß¼º °ñ¼öÁ¾ ȯÀÚÀÇ Ä¡·á |
´ë»ó ÀûÀÀÁõ Áúȯ Ư¼º | • ´Ù¹ß¼º °ñ¼öÁ¾(multiple myeloma)Àº ºñÁ¤»óÀûÀÎ ÇüÁú ¼¼Æ÷°¡ °ñ¼ö¿¡ ÃàÀûµÇ¾î »À¿¡ Á¾¾çÀ» Çü¼ºÇÏ´Â Èñ±Í À¯ÇüÀÇ Ç÷¾×¾ÏÀ¸·Î, ¿øÀÎ ºÒ¸íÀÓ - °Ç°ÇÑ Ç÷¾×¼¼Æ÷¸¦ ÃæºÐÈ÷ »ý¼ºÇÏÁö ¸øÇØ Ç÷±¸ ¼ö°¡ ³·¾ÆÁú ¼ö ÀÖÀ¸¸ç »À¿Í ½ÅÀåÀÇ ¼Õ»ó, ¸é¿ª½Ã½ºÅÛ ¾àÈ µÉ ¼ö ÀÖÀ½ • ¹Ì±¹ ±¹¸³¾Ï¿¬±¸¼Ò(National Cancer Institute)¿¡ ÀÇÇϸé, ¡®20³â ¹Ì±¹¿¡¼ ¹ß»ýÇÑ ½Å±Ô ¾Ï Áø´Ü »ç·ÊÀÇ ¾à 1.8%°¡ °ñ¼öÁ¾ÀÓ |
ÀÛ¿ë ±âÀü | • ¡®Abecma¡¯´Â ȯÀÚ ÀÚ½ÅÀÇ T¼¼Æ÷(¹éÇ÷±¸ÀÇ ÀÏÁ¾)¸¦ »ç¿ëÇÏ¿© ¸¸µç ¸ÂÃã Ä¡·á¹ýÀÓ (BCMA1)-Ÿ±ê À¯ÀüÀÚ º¯Çü Å°¸Þ¸¯ Ç׿ø ¼ö¿ëü(CAR2)) T¼¼Æ÷ Ä¡·áÁ¦) 1) BCMA (B-cell maturation antigen) 2) CAR (Chimeric Antigen Receptor) • ȯÀÚ¿¡°Ô¼ È®º¸µÈ T¼¼Æ÷¸¦ ¸²ÇÁÁ¾ Ç¥ÀûÈ ¹× »ç¸êÀ» ÃËÁøÇÏ´Â »õ·Î¿î À¯ÀüÀÚ°¡ Æ÷ÇԵǵµ·Ï À¯ÀüÀÚ º¯ÇüÇÏ¿© ȯÀÚ¿¡°Ô Åõ¿©ÇÔ |
ÀÓ»ó½ÃÇè Á¤º¸ | • Àç¹ß¼º(Ä¡·á ¿Ï·á ÀÌÈÄ Àç¹ß) ¶Ç´Â ºÒÀÀ¼º(ÃÖ¼Ò ¼¼ °¡Áö ÀÌ»óÀÇ Ä¡·á¿¡ ¹ÝÀÀÇÏÁö ¾ÊÀ½) °ñ¼öÁ¾ ȯÀÚ 127¸í ´ë»ó ´Ù±â°ü ÀÓ»ó½ÃÇè °á°ú, 72%ÀÇ È¯ÀÚ¿¡¼ ºÎºÐÀûÀ¸·Î (partially) ¶Ç´Â ¿ÏÀüÈ÷(completely) ¹ÝÀÀÇÔ - ¡®Abecma¡¯ Ä¡·á ÈÄ 28% ȯÀÚ°¡ ¿ÏÀü ¹ÝÀÀ(complete response)(¶Ç´Â ´Ù¹ß¼º °ñ¼öÁ¾ÀÇ ¸ðµç ¡ÈÄ »ç¶óÁü)À» º¸¿´À¸¸ç, ÀÌ Áß 65%¿¡¼ Ä¡·á ÈÄ ÃÖ¼Ò 12°³¿ù µ¿¾È ¿ÏÀü ¹ÝÀÀÀÌ À¯ÁöµÊ * ÀÓ»ó½ÃÇè ¼³°è ¼¼ºÎ Á¤º¸´Â ¡°KarMMa (NCT03361748) (¢ºClinicalTrials.gov¿¡¼ »ó¼¼º¸±â)¡±¿¡¼ È®ÀÎ °¡´É * ÀÓ»ó½ÃÇè °á°ú´Â "Package Insert - Abecma" '14. Clinical Studies'¿¡¼ È®ÀÎ °¡´É |
ºÎÀÛ¿ë µî | • ¡®Abecma¡¯´Â ´ÙÀ½°ú °°Àº »ý¸íÀ» À§ÇùÇÏ´Â ½É°¢ÇÑ ºÎÀÛ¿ëÀ» À¯¹ßÇÒ °¡´É¼ºÀÌ ÀÖÀ½ - CAR-T ¼¼Æ÷ÀÇ È°¼ºÈ ¹× Áõ½Ä¿¡ ´ëÇÑ Àü½Å¹ÝÀÀÀ¸·Î °í¿°ú µ¶°¨ °°Àº Áõ»ó À¯¹ßÇÏ´Â »çÀÌÅäÄ«ÀÎ ¹æÃ⠽ŵå·Ò(CRS3)), Ç÷±¸Æ÷½Ä ¸²ÇÁÁ¶Á÷±¸Áõ½ÄÁõ(HLH/MAS4)) 3) CRS (cytokine release syndrome) 4) HLH/MAS (hemophagocytic lymphohistiocytosis/ macrophage activation syndrome) - ½Å°æ µ¶¼º, Àå±âÀûÀÎ Ç÷±¸°¨¼ÒÁõ - Á¦Á¶¾÷ÀÚ´Â ¡¯Abecma¡¯ Åõ¿©¹ÞÀº ȯÀÚ ´ë»ó ½ÃÆÇ ÈÄ °üÂû¿¬±¸¸¦ ¼öÇàÇØ¾ß ÇÔ • °¡Àå ÈçÇÑ ºÎÀÛ¿ëÀ¸·Î CRS, °¨¿°, ÇÇ·Î, ±Ù°ñ°Ý¼º ÅëÁõ, ¸é¿ª½Ã½ºÅÛ ¾àÈ µî |
±âŸ | • Èñ±ÍÀǾàÇ° ÁöÁ¤ (Orphan Drug Designation) • Çõ½ÅÀǾàÇ° ÁöÁ¤ (Breakthrough Therapy) • ´Ù¹ß¼º °ñ¼öÁ¾ Ä¡·á¸¦ À§ÇØ FDA ÃÖÃÊ ½ÂÀÎµÈ ¼¼Æ÷ ±â¹Ý À¯ÀüÀÚÄ¡·áÁ¦ |