A ranar 6 ga Satumba, 2021, JW Therapeutics ta sanar da cewa Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta kasar Sin ta amince da amfani da Sabon Maganin Magani (NDA) don maganin rigakafin CD19 autologous chimeric antigen receptor T (CAR-T) na allurar rigakafi ta sel relmacabtagene autoleucel (relma-cel) don maganin manya marasa lafiya da suka sake kamuwa ko suka yi rashin lafiya bayan layuka biyu ko fiye na maganin tsari, kuma ta fitar da takardar shaidar yin rijistar magani. Relma-cel ita ce samfurin CAR-T na farko da aka amince da shi a matsayin samfurin halittu na Rukuni na 1 a kasar Sin, kuma samfurin CAR-T na shida da aka amince da shi a duk duniya.
Game da Allurar Relmacabtagene Autoleucel (sunan kasuwanci: Carteyva®)
Allurar Relmacabtagene autoleucel (wanda aka takaita a matsayin relma-cel, sunan kasuwanci: Carteyva) wani samfurin rigakafi ne na ƙwayoyin CAR-T masu hana CD19 wanda JW Therapeutics suka haɓaka shi daban-daban bisa ga dandamalin tsarin ƙwayoyin CAR-T na Juno Therapeutics (kamfanin Bristol Myers Squibb).
Wannan amincewar ta dogara ne akan sakamakon wani bincike mai hannu ɗaya, mai cibiya da yawa, mai mahimmanci (nazarin RELIANCE) don kimanta inganci da amincin relma-cel a cikin marasa lafiya da ke fama da r/r LBCL a China. Sakamakon binciken RELIANCE ya nuna cewa relma-cel ya nuna yawan amsawar cututtuka masu ɗorewa da ƙarancin guba da ke da alaƙa da CAR-T, kuma yana iya samar da mafi kyawun bayanin maganin CAR-T.
A taron shekara-shekara na 24 na ƙungiyar kula da cututtukan daji ta ƙasar Sin (CSCO), JW Therapeutics ta sanar da sabunta sakamakon shekara 1 na allurar relmacabtagene autoleucel (relma-cel) don maganin r/r LBCL. Sakamakon ya haɗa da:
Relma-cel ta nuna amsoshi masu ɗorewa da fa'idar rayuwa ta dogon lokaci; Mafi kyawun Matsakaicin Amsawa (ORR) shine 77.6%, Mafi kyawun Matsakaicin Amsawa (CRR) shine 51.7% kuma Jimlar Rayuwa ta Shekara 1 (OS) shine 76.8% tare da matsakaicin bin diddigin watanni 17.9;
An jure wa Relma-cel sosai tare da yanayin tsaro wanda ya haɗa da ƙarancin cutar Cytokine Release Syndrome (≥grade 3) na 5.1% da ƙarancin mummunan ƙimar cutar neurotoxicity (≥grade 3) na 3.4%, kuma babu sabbin siginar aminci tare da matsakaicin watanni 17.9 na bin diddigin cutar;
Binciken dogon lokaci na binciken RELIANCE ya tabbatar da dorewar amsawar da kuma tsarin aiki na dogon lokaci tare da maganin relma-cel, wanda kuma yana da alaƙa da ƙarancin guba da ke da alaƙa da CAR-T.
LBCL ita ce nau'in lymphoma wanda ba Hodgkin ba ne ya fi yawa kuma mai tsanani kuma yawancin marasa lafiya suna komawa bayan jiyya ta farko tare da ƙarancin zaɓuɓɓukan magani tare da hanyoyin magani na yau da kullun da matsakaicin rayuwa na kimanin watanni 6. Waɗannan bayanan bibiya na dogon lokaci da aka ruwaito daga binciken RELIANCE sun tabbatar da dorewar martani bayan maganin relma-cel, suna wakiltar wani zaɓi mai mahimmanci na magani ga waɗannan marasa lafiya wanda da alama yana ba da kyakkyawan fata na tsawon rai.
A halin yanzu, akwai wasu gwaje-gwajen asibiti da yawa na CAR-T a China, kuma suna neman marasa lafiya. Don neman shawara kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Kasa da Kasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Nassoshi
2.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20210903084004127.html
3.https://www.sciencedirect.com/science/article/pii/S0006497118704138
4.https://www.jwtherapeutics.com/en/media/press-release/jw-therapeutics-announces-updated-1-year-follow-up-result-of-relmacabtagene-autoleucel-injection-at-the-24th-annual-meeting-of-the-chinese-society-of-clinical-oncology-csco-1/
Lokacin Saƙo: Nuwamba-15-2024