Ọgwụ Relmacabtagene Autoleucel

Na Septemba 6, 2021, JW Therapeutics kwupụtara na National Medical Products Administration (NMPA) nke China akwadola Ngwa Ọgwụ Ọhụrụ (NDA) maka ọgwụ mgbochi-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (relma-cel) maka ọgwụgwọ nke ndị ọrịa toro eto nwere nnukwu B-cell lymphoma (r/r LBCL) nke laghachiri azụ ma ọ bụ nke na-adịghị ike mgbe usoro ọgwụgwọ sistemụ abụọ ma ọ bụ karịa gasịrị, ma wepụta asambodo ndebanye aha ọgwụ. Relma-cel bụ ngwaahịa CAR-T mbụ akwadoro dị ka ngwaahịa biologics nke Category 1 na China, yana ngwaahịa CAR-T nke isii akwadoro n'ụwa niile.

Banyere Ọgwụ Relmacabtagene Autoleucel (aha azụmaahịa: Carteyva®)

Ọgwụ Relmacabtagene autoleucel (nke a kpọrọ relma-cel, aha azụmaahịa: Carteyva) bụ ngwaahịa ọgwụ mgbochi mkpụrụ ndụ CAR-T nke na-egbochi CD19 nke JW Therapeutics mepụtara n'onwe ya dabere na ikpo okwu usoro mkpụrụ ndụ CAR-T nke Juno Therapeutics (ụlọ ọrụ Bristol Myers Squibb).

Nkwenye a dabere na nsonaazụ nke ọmụmụ otu aka, ọtụtụ etiti, dị mkpa (ọmụmụ RELIANCE) iji nyochaa irè na nchekwa nke relma-cel na ndị ọrịa nwere r/r LBCL na China. Nsonaazụ ọmụmụ RELIANCE na-egosi na relma-cel gosipụtara oke nzaghachi ọrịa na-adịgide adịgide na obere ọnụego nke nsí ndị metụtara CAR-T, ma nwee ike inye profaịlụ ọgwụgwọ CAR-T kacha mma na ọkwa.

Na Nzukọ Kwa Afọ nke 24 nke Chinese Society of Clinical Oncology (CSCO), JW Therapeutics kwupụtara nsonaazụ nyocha afọ 1 nke relmacabtagene autoleucel injection (relma-cel) maka ọgwụgwọ r/r LBCL. Nsonaazụ gụnyere:

Relma-cel gosipụtara mmeghachi omume siri ike na uru ndụ ogologo oge; Ọnụego Nzaghachi Kasị Mma (ORR) bụ 77.6%, Ọnụego Nzaghachi Kasị Mma (CRR) bụ 51.7% na Ọnụego Nzaghachi Kasị Mma (OS) nke afọ 1 bụ 76.8% yana nleba anya etiti nke ọnwa 17.9;

A na-anabata Relma-cel nke ọma site na nchekwa dịka obere Cytokine Release Syndrome (≥grade 3) nke 5.1% na obere oke neurotoxicity (≥grade 3) nke 3.4%, na enweghị akara nchekwa ọhụrụ nke dị n'etiti ọnwa 17.9 nke nleba anya;

Nnyocha ogologo oge nke ọmụmụ RELIANCE egosila na nzaghachi na-adịgide adịgide na ọgwụgwọ relma-cell ogologo oge, nke jikọtara ya na obere ọnụọgụ nke nsí ndị metụtara CAR-T.

LBCL bụ ụdị lymphoma na-abụghị Hodgkin kachasị na nke siri ike, ọtụtụ ndị ọrịa na-alaghachikwa mgbe ọgwụgwọ mbụ gasịrị, ha nwere obere ọgwụgwọ na ọgwụgwọ ọkọlọtọ, ha na-adịkwa ndụ ruo ihe dị ka ọnwa isii. Data ndị a na-esochi ogologo oge a kọrọ site na ọmụmụ RELIANCE egosila na nzaghachi ndị a na-adịgide adịgide mgbe ọgwụgwọ relma-cel gasịrị, na-anọchite anya nhọrọ ọgwụgwọ dị mkpa maka ndị ọrịa a nke yiri ka ọ na-enye olileanya doro anya maka ndụ ogologo oge.

Ugbu a, enwere ọtụtụ nnwale ụlọ ọgwụ CAR-T ndị ọzọ na China, ha na-achọkwa ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ ọhụrụ na teknụzụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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Ntụaka

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/