Relmacabtagene Autoleucel Injection

Musi wa6 Gunyana, 2021, JW Therapeutics yakazivisa kuti National Medical Products Administration (NMPA) yeChina yakabvumidza New Drug Application (NDA) ye anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (relma-cel) yekurapa varwere vakuru vane relapse or refractory large B-cell lymphoma (r/r LBCL) mushure memitsetse miviri kana kupfuura yesystemic therapy, uye yakaburitsa chitupa chekunyoresa mushonga. Relma-cel ndiyo yekutanga CAR-T product yakagamuchirwa seCategory 1 biologics product muChina, uye yechitanhatu CAR-T product yakagamuchirwa pasi rose.

Nezve Relmacabtagene Autoleucel Injection (zita rekutengeserana: Carteyva®)

Relmacabtagene autoleucel injection (yakapfupikiswa se relma-cel, zita rekutengeserana: Carteyva) chigadzirwa che autologous anti-CD19 CAR-T cell immunotherapy chakagadzirwa chakazvimiririra neJW Therapeutics zvichibva papuratifomu yeCAR-T cell process yeJuno Therapeutics (kambani yeBristol Myers Squibb).

Kubvumidzwa uku kwakavakirwa pamhedzisiro yechidzidzo chepfungwa cheruoko rumwe chete, chine nzvimbo dzakawanda, (chidzidzo cheRELIANCE) chekuongorora kushanda uye kuchengetedzeka kwerelma-cel muvarwere vane r/r LBCL muChina. Mhedzisiro yechidzidzo cheRELIANCE inoratidza kuti relma-cel yakaratidza huwandu hwakakura hwekupindura kwechirwere kwenguva refu uye huwandu hwakaderera hwechepfu hunokonzerwa neCAR-T, uye inogona kupa hunyanzvi hwepamusoro hwekurapa kweCAR-T.

PaMusangano weGore negore wechi24 weChinese Society of Clinical Oncology (CSCO), JW Therapeutics yakazivisa mhedzisiro yekutevera yakagadziridzwa yegore rimwe chete ye relmacabtagene autoleucel injection (relma-cel) yekurapa r/r LBCL. Mhedzisiro inosanganisira:

Relma-cel yakaratidza mhinduro dzinogara kwenguva refu uye purofiti yekurarama kwenguva refu; Best Overall Response Rate (ORR) yaive 77.6%, Best Complete Response Rate (CRR) yaive 51.7% uye 1-year Overall Survival (OS) yaive 76.8% neavhareji yekutevera kwemwedzi 17.9;

Relma-cel yaiwanzo bvumidzwa zvakanaka nekuchengetedzwa kwakabatana neCytokine Release Syndrome yakaderera (≥giredhi 3) ye5.1% uye mwero wakaderera wechepfu yetsinga (≥giredhi 3) we3.4%, uye pasina zviratidzo zvitsva zvekuchengetedza zvine avhareji yemwedzi 17.9 yekutevera;

Kutevera kwenguva refu kwechidzidzo cheRELIANCE kwakasimbisa kugara kwenguva refu kwemhinduro uye OS kwenguva refu nekurapwa kwerelma-cel, izvo zvakabatanawo nehuwandu hwakaderera hwehupfu hunokonzerwa neCAR-T.

LBCL ndiyo mhando ye non-Hodgkin lymphoma inonyanya kupararira uye ine hasha uye varwere vazhinji vanodzokera shure mushure mekurapwa kwekutanga nesarudzo shoma dzekurapa nekurapwa kwakajairika uye kurarama kwepakati kweinenge mwedzi mitanhatu. Ruzivo urwu rwekutevera kwenguva refu rwakaburitswa kubva kuongororo ye RELIANCE rwakasimbisa kugara kwenguva refu kwemhinduro mushure mekurapwa kwe relma-cel, zvichimiririra sarudzo yakakosha yekurapa kwevarwere ava inoita seinopa tariro yakajeka yekupona kwenguva refu.

Parizvino, kune mimwe miedzo yakawanda yeCAR-T muChina, uye vari kutsvaga varwere. Kuti muwane mazano pamusoro pemishonga mitsva netekinoroji, munogona kubata Beijing South Region Oncology Hospital International Department.

Nhamba yefoni: 4008803716

Email：myimmnet@163.com

Mareferensi

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/