ʻO ka inikini Relmacabtagene Autoleucel

Ma ka lā 6 o Kepakemapa, 2021, ua hoʻolaha ʻo JW Therapeutics ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i ka New Drug Application (NDA) no kāna huahana immunotherapy cell anti-CD19 autologous chimeric antigen receptor T (CAR-T) relmacabtagene autoloucel injection (relma-cel) no ka mālama ʻana i nā maʻi makua me ka relapsed a refractory paha large B-cell lymphoma (r/r LBCL) ma hope o ʻelua a ʻoi aku paha laina o ka systemic therapy, a ua hoʻokuʻu i ka palapala hōʻoia hoʻopaʻa inoa lāʻau. ʻO Relma-cel ka huahana CAR-T mua i ʻāpono ʻia ma ke ʻano he huahana biologics Category 1 ma Kina, a ʻo ke ono o ka huahana CAR-T i ʻāpono ʻia ma ka honua holoʻokoʻa.

E pili ana iā Relmacabtagene Autoleucel Injection (inoa kālepa: Carteyva®)

ʻO ka Relmacabtagene autoloucel injection (i hoʻopōkole ʻia e like me relma-cel, inoa kālepa: Carteyva) he huahana immunotherapy cell CAR-T autologous anti-CD19 i hoʻomohala kūʻokoʻa ʻia e JW Therapeutics ma muli o kahi kahua hana cell CAR-T o Juno Therapeutics (kahi hui ʻo Bristol Myers Squibb).

Hoʻokumu ʻia kēia ʻae ʻia ma nā hopena o kahi noiʻi hoʻokahi lima, multi-center, pivotal (RELIANCE study) e loiloi i ka pono a me ka palekana o relma-cel i nā poʻe maʻi me r/r LBCL ma Kina. Hōʻike nā hopena o ka noiʻi RELIANCE ua hōʻike ʻo relma-cel i nā helu kiʻekiʻe o ka pane maʻi paʻa a me nā helu haʻahaʻa o nā mea ʻawaʻawa e pili ana iā CAR-T, a hiki ke hāʻawi i kahi ʻano lapaʻau CAR-T maikaʻi loa.

Ma ka Hālāwai Makahiki 24 o ka Chinese Society of Clinical Oncology (CSCO), ua hoʻolaha ʻo JW Therapeutics i ka hopena o ka nānā hou ʻana i hoʻokahi makahiki o ka inikini relmacabtagene autoleucel (relma-cel) no ka mālama ʻana i ka r/r LBCL. ʻO nā hopena:

Ua hōʻike ʻo Relma-cel i nā pane paʻa a me ka pōmaikaʻi ola lōʻihi; ʻo ka Best Overall Response Rate (ORR) he 77.6%, ʻo ka Best Complete Response Rate (CRR) he 51.7% a ʻo 1-makahiki Overall Survival (OS) he 76.8% me ka awelika o 17.9 mahina;

Ua ʻae maikaʻi ʻia ʻo Relma-cel me kahi ʻano palekana e komo pū ana me ka Cytokine Release Syndrome haʻahaʻa koʻikoʻi (≥grade 3) o 5.1% a me ka helu neurotoxicity haʻahaʻa koʻikoʻi (≥grade 3) o 3.4%, a ʻaʻohe hōʻailona palekana hou me ka awelika o 17.9 mau mahina o ka hahai ʻana;

Ua hōʻoia ka hahai lōʻihi ʻana o ke aʻo ʻana ʻo RELIANCE i ka lōʻihi o ka pane a me ka OS lōʻihi me ka mālama ʻana o relma-cel, kahi i pili pū ʻia me nā helu haʻahaʻa o nā mea ʻawaʻawa e pili ana iā CAR-T.

ʻO LBCL ke ʻano maʻamau a me ka hoʻouka kaua o ka lymphoma non-Hodgkin a ʻo ka hapa nui o nā maʻi e hoʻi hou ma hope o nā hoʻōla mua me nā koho lapaʻau palena me nā hoʻōla maʻamau a me ke ola waena o kahi o 6 mau mahina. Ua hōʻoia kēia mau ʻikepili hahai lōʻihi i hōʻike ʻia mai ka noiʻi RELIANCE i ka lōʻihi o nā pane ma hope o ka mālama ʻana iā relma-cel, e hōʻike ana i kahi koho lapaʻau koʻikoʻi no kēia mau maʻi e hāʻawi ana i ka manaʻolana maopopo o ke ola lōʻihi.

I kēia manawa, nui nā hoʻokolohua lapaʻau CAR-T ʻē aʻe ma Kina, a ke ʻimi nei lākou i nā maʻi. No ke kūkākūkā ʻana i nā lāʻau lapaʻau hou a me nā ʻenehana, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

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Nā Kuhikuhi

1.https://www.jwtherapeutics.com/en/media/press-release/jw-therapeutics-announces-nmpa-approval-of-relmacabtagene-autoleucel-injection-in-china/

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/