Werohanga Relmacabtagene Autoleucel

I te 6 o Hepetema, 2021, i panuitia e JW Therapeutics kua whakaaetia e te National Medical Products Administration (NMPA) o Haina te New Drug Application (NDA) mō tana hua immunotherapy pūtau anti-CD19 autologous chimeric antigen receptor T (CAR-T) relmacabtagene autoloucel injection (relma-cel) hei rongoā i ngā tūroro pakeke me te lymphoma pūtau-B nui kua hoki mai, kua ātete rānei ki te mate (r/r LBCL) i muri i te rua, neke atu rānei o ngā raina rongoā pūnaha, ā, kua tukuna te tiwhikete rēhitatanga rongoā. Ko Relma-cel te hua CAR-T tuatahi kua whakaaetia hei hua koiora Kāwai 1 i Haina, me te tuaono o ngā hua CAR-T kua whakaaetia puta noa i te ao.

Mō te Werohanga Relmacabtagene Autoleucel (ingoa hokohoko: Carteyva®)

Ko te werohanga Relmacabtagene autoleucel (whakarāpopototanga ko relma-cel, ingoa hokohoko: Carteyva) he hua ārai mate pūtau CAR-T anti-CD19 autologous i whakawhanakehia motuhaketia e JW Therapeutics i runga i te tūāpapa tukanga pūtau CAR-T a Juno Therapeutics (he kamupene Bristol Myers Squibb).

Ko tēnei whakaaetanga i ahu mai i ngā hua o tētahi rangahau kotahi-ringa, maha-pokapū, matua (rangahau RELIANCE) hei aromatawai i te whai huatanga me te haumaru o te relma-cel i roto i ngā tūroro he r/r LBCL i Haina. E whakaatu ana ngā hua o te rangahau RELIANCE i whakaatu a relma-cel i ngā reiti teitei o te urupare mate roa me ngā reiti iti o ngā paitini e pā ana ki te CAR-T, ā, tera pea ka whakaratohia he kōtaha rongoā CAR-T pai rawa atu.

I te Hui-ā-Tau 24 o te Rōpū Hainamana mō te Mate Pūkahukahu Hauora (CSCO), i pānuitia e JW Therapeutics te hua arotakenga kotahi-tau kua whakahoutia mō te werohanga relmacabtagene autoleucel (relma-cel) mō te rongoā i te r/r LBCL. Ko ngā hua ko:

I whakaatuhia e Relma-cel ngā urupare roa me te painga oranga mō te wā roa; ko te Auau Urupare Whānui Pai rawa atu (ORR) he 77.6%, ko te Auau Urupare Katoa Pai rawa atu (CRR) he 51.7% me te Ora Whānui 1-tau (OS) he 76.8% me te aroturukitanga toharite o te 17.9 marama;

I te nuinga o te wā, i tino pai te manawanui ki a Relma-cel, ā, he iti te kino o te Cytokine Release Syndrome (≥grade 3) o te 5.1% me te iti te kino o te neurotoxicity (≥grade 3) o te 3.4%, ā, kāore he tohu haumaru hou me te toharite o te 17.9 marama o te whai i te maimoatanga;

Kua whakaūtia e te whai-ake roa o te rangahau RELIANCE te roa o te urupare me te OS roa me te maimoatanga relma-cel, i honoa hoki ki te iti o ngā reiti paitini e pā ana ki te CAR-T.

Ko te LBCL te momo lymphoma kore-Hodgkin tino noa, tino pukuriri hoki, ā, ko te nuinga o ngā tūroro ka hoki anō ki te mate i muri i ngā maimoatanga tuatahi me ngā kōwhiringa maimoatanga iti me ngā maimoatanga paerewa, me te oranga toharite tata ki te 6 marama. Kua whakaūhia e ēnei raraunga whai muri i te rangahau RELIANCE te roa o ngā urupare i muri i te maimoatanga relma-cel, he kōwhiringa maimoatanga nui pea mō ēnei tūroro e whakaatu ana i te tumanako mārama mō te oranga roa.

I tēnei wā, he maha atu ngā whakamātautau haumanu CAR-T i Haina, ā, kei te rapu tūroro rātou. Mō te kōrerorero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

Tau Waea：4008803716

Email：myimmnet@163.com

Ngā Tohutoro

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/