I-Relmacabtagene Autoleucel Injection

NgoSepthemba 6, 2021, i-JW Therapeutics yamemezela ukuthi i-National Medical Products Administration (NMPA) yaseShayina ivumile i-New Drug Application (NDA) yomkhiqizo wayo we-anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (relma-cel) yokwelapha iziguli ezindala ezine-relapse noma refractory large B-cell lymphoma (r/r LBCL) ngemuva kwemigqa emibili noma ngaphezulu yokwelashwa kwesistimu, futhi ikhiphe isitifiketi sokubhaliswa kwemithi. I-Relma-cel ingumkhiqizo wokuqala we-CAR-T ovunyelwe njengomkhiqizo we-biologics weSigaba 1 eShayina, kanye nomkhiqizo wesithupha ovunyelwe we-CAR-T emhlabeni jikelele.

Mayelana ne-Relmacabtagene Autoleucel Injection (igama lokuhweba: Carteyva®)

I-Relmacabtagene autoleucel injection (efushanisiwe ngokuthi i-relma-cel, igama lokuhweba: i-Carteyva) umkhiqizo we-autologous anti-CD19 CAR-T cell immunotherapy owakhiwe ngokuzimela yi-JW Therapeutics ngokusekelwe kupulatifomu yenqubo yamaseli e-CAR-T ye-Juno Therapeutics (inkampani yaseBristol Myers Squibb).

Lokhu kuvunyelwa kusekelwe emiphumeleni yocwaningo oluyingalo eyodwa, olunezikhungo eziningi, olubalulekile (isifundo se-RELIANCE) ukuhlola ukusebenza kahle nokuphepha kwe-relma-cel ezigulini ezine-r/r LBCL eShayina. Imiphumela yocwaningo lwe-RELIANCE ikhombisa ukuthi i-relma-cel ibonise amazinga aphezulu okusabela kwesifo okuhlala isikhathi eside kanye namazinga aphansi obuthi obuhambisana ne-CAR-T, futhi inganikeza iphrofayili yokwelapha ye-CAR-T engcono kakhulu.

Emhlanganweni Waminyaka Yonke wama-24 we-Chinese Society of Clinical Oncology (CSCO), i-JW Therapeutics imemezele imiphumela yokulandelela yonyaka owodwa ebuyekeziwe yomjovo we-relmacabtagene autoleucel (relma-cel) wokwelapha i-r/r LBCL. Imiphumela ihlanganisa:

I-Relma-cel ibonise izimpendulo ezihlala isikhathi eside kanye nenzuzo yokusinda isikhathi eside; Izinga Eliphezulu Lokuphendula Okuphelele (ORR) lalingu-77.6%, Izinga Eliphezulu Lokuphendula Okuphelele (CRR) lalingu-51.7% kanye ne-Overall Survival (OS) yonyaka owodwa yayingu-76.8% kanye nokulandelela okumaphakathi kwezinyanga ezingu-17.9;

I-Relma-cel ngokuvamile yayibekezelelwa kahle ngephrofayili yokuphepha ehlanganisa i-Cytokine Release Syndrome ephansi kakhulu (≥ibanga lesi-3) elingu-5.1% kanye nesilinganiso esiphansi sobuthi be-neurotoxicity (≥ibanga lesi-3) esingu-3.4%, futhi azikho izimpawu zokuphepha ezintsha ezinesilinganiso sezinyanga ezingu-17.9 zokulandelela;

Ukulandelwa kwesikhathi eside kocwaningo lwe-RELIANCE kuqinisekisile ukuqina kwempendulo kanye ne-OS yesikhathi eside ngokwelashwa kwe-relma-cel, okubuye kuhlotshaniswe namazinga aphansi obuthi obuhambisana ne-CAR-T.

I-LBCL uhlobo oluvame kakhulu nolunolaka lwe-non-Hodgkin lymphoma futhi iziguli eziningi ziyabuya emuva ngemva kokwelashwa kokuqala okunezinketho zokwelapha ezilinganiselwe ngemithi ejwayelekile kanye nokusinda okumaphakathi kwezinyanga ezingaba ngu-6. Le datha yokulandelela yesikhathi eside ebikwe ocwaningweni lwe-RELIANCE iqinisekisile ukuqina kwezimpendulo ngemuva kokwelashwa kwe-relma-cel, okumelela inketho yokwelapha engaba yinto ebalulekile kulezi ziguli ebonakala inikeza ithemba elicacile lokusinda isikhathi eside.

Njengamanje, kunezinye izivivinyo eziningi ze-CAR-T eShayina, futhi zifuna iziguli. Ukuze uthole ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

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/