Inshinge za Relmacabtagene Autoleucel

Ku ya 6 Nzeri 2021, JW Therapeutics yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) mu Bushinwa cyemeje Porogaramu Nshya y’Imiti (NDA) ku gikoresho cyayo cyo kurwanya CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (relma-cel) yo kuvura abarwayi bakuru bafite lymphoma ya B-cell lymphoma (r/r LBCL) yasubiwemo cyangwa itarakira nyuma y’imirongo ibiri cyangwa irenga yo kuvura, kandi yasohoye icyemezo cyo kwiyandikisha ku miti. Relma-cel ni yo gikoresho cya mbere cya CAR-T cyemewe nk'igicuruzwa cya mbere cya biologics mu Bushinwa, ikaba n'igikoresho cya gatandatu cya CAR-T cyemewe ku isi.

Ku bijyanye na Relmacabtagene Autoleucel Injection (izina ry'ubucuruzi: Carteyva®)

Inshinge ya Relmacabtagene autoleucel (ihinnye nka relma-cel, izina ry'ubucuruzi: Carteyva) ni umuti wo kuvura ubudahangarwa bw'uturemangingo twa CD19 CAR-T wakozwe ku giti cyawo na JW Therapeutics hashingiwe ku buryo bwa CAR-T bwa Juno Therapeutics (isosiyete ya Bristol Myers Squibb).

Ubu bwemere bushingiye ku byavuye mu bushakashatsi bwakozwe ku ruhande rumwe, mu nzego nyinshi, mu buryo bw’ingenzi (inyigo ya RELIANCE) kugira ngo harebwe akamaro n’umutekano wa relma-cel ku barwayi bafite r/r LBCL mu Bushinwa. Ibisubizo by’ubushakashatsi bwa RELIANCE bigaragaza ko relma-cel yagaragaje igipimo cyo hejuru cyo guhangana n’indwara zirambye n’igipimo gito cy’uburozi buterwa na CAR-T, kandi ishobora gutanga imiterere myiza y’ubuvuzi bwa CAR-T.

Mu nama ngarukamwaka ya 24 y’Umuryango w’Abashinwa wita ku ndwara za kanseri (CSCO), JW Therapeutics yatangaje ibyavuye mu ikurikirana ry’umwaka umwe ryakozwe n’umuti wa relmacabtagene autoleucel inshinge (relma-cel) mu kuvura r/r LBCL. Ibisubizo birimo:

Relma-cel yagaragaje ibisubizo birambye n'inyungu z'igihe kirekire zo kubaho; Igipimo cyiza cy'ingaruka rusange (ORR) cyari 77.6%, Igipimo cyiza cy'ingaruka rusange (CRR) cyari 51.7% naho Ubusugire rusange bw'umwaka umwe (OS) bwari 76.8%, hakaba harakurikiranywe amezi 17.9;

Muri rusange, Relma-cel yihanganirwaga neza hamwe n’ubwiza bw’umutekano burimo indwara yoroshye cyane ya Cytokine Release Syndrome (≥icyiciro cya 3) ya 5.1% n’igipimo gito cy’uburozi bw’ubwonko (≥icyiciro cya 3) cya 3.4%, kandi nta bimenyetso bishya by’umutekano bifite igipimo cy’amezi 17.9 yo gukurikiranwa;

Gukurikirana igihe kirekire ubushakashatsi bwa RELIANCE bwemeje ko uburyo bwo gusubiza ibintu mu buryo burambye n’uburyo bwo gukoresha relma-cel mu gihe kirekire, ibyo bikaba byaranajyanye n’igipimo gito cy’uburozi buterwa na CAR-T.

LBCL ni yo ndwara ikunze kugaragara cyane kandi ikomeye ya lymphoma itari Hodgkin, kandi abarwayi benshi bongera gusubira inyuma nyuma yo kuvurwa bwa mbere hamwe n’uburyo buke bwo kuvura hakoreshejwe uburyo busanzwe bwo kuvura ndetse n’igihe cy’amezi agera kuri 6. Aya makuru y’ikurikirana ry’igihe kirekire yatangajwe n’ubushakashatsi bwa RELIANCE yemeje ko ibisubizo biramba nyuma yo kuvurwa na relma-cel, bikaba ari uburyo bw’ingenzi bwo kuvura kuri abo barwayi busa n’aho butanga icyizere cyo kuramba.

Kuri ubu, hari andi magerageza menshi ya CAR-T mu Bushinwa, kandi barimo gushaka abarwayi. Kugira ngo ubone inama ku miti mishya n'ikoranabuhanga, ushobora kuvugana n'Ishami Mpuzamahanga ry'Ibitaro bya Oncology bya Beijing Region South.

Nimero ya Terefone: 4008803716

Email：myimmnet@163.com

Amareferensi

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/