Satumba 2022: Hukumar Tarayyar Turai (EC) ta ba da izinin Kite's CAR T-cell far Tecartus® (brexucabtagene autoleucel) don kula da manya marasa lafiya shekaru 26 da haihuwa tare da koma baya ko refractory (r/r) B-cell precursor m lymphoblastic cutar sankarar bargo. Kite Kamfanin Gileyad ne (Nasdaq: GILD) (DUK).
A cewar Christi Shaw, Shugaba na Kite, "Tare da wannan amincewa, Tecartus ya zama na farko kuma kawai CAR T-cell far da aka ba da shawarar ga wannan yawan majiyyaci, yana magance babban buƙatun likita." Wannan kuma shine karo na huɗu da aka amince da amfani da Kite cell therapy a Turai, yana mai nuna fa'idar da suke samarwa ga marasa lafiya, musamman waɗanda ke da ƴan sauran hanyoyin warkewa.
Mafi yaɗuwar nau'in ALL, wanda shine m jini malignancy, shi ne B-cell precursor ALL. A kowace shekara, ALL ana bincikar su a cikin kusan mutane 64,000 a duk duniya. Tare da magungunan kulawa na yau da kullun, matsakaiciyar rayuwa ta gaba ɗaya (OS) ga daidaikun mutane tare da DUK kusan watanni takwas ne.
A cewar Max S. Topp, MD, farfesa kuma darektan ilimin jini a Asibitin Jami'ar Wuerzburg a Jamus, "manyan da ke fama da koma baya ko rashin jin daɗi ALL akai-akai suna shan jiyya da yawa, ciki har da chemotherapy, farfesa da aka yi niyya, da dashen kwayar halitta, yana haifar da babban nauyi. akan ingancin rayuwar marar lafiya." Marasa lafiya a Turai a yau suna amfana daga gagarumin ci gaba a cikin kulawa. Amsoshi masu ɗorewa daga Tecartus suna nuna yuwuwar gafara na dogon lokaci da dabarun jiyya.
ZUMA-3 na kasa da kasa multicenter, guda-hannu, bude-lakabin, rajista Phase 1/2 nazarin manya marasa lafiya (shekaru 18) tare da koma baya ko refractory DUK bayar da sakamakon da goyon bayan yarda. Tare da bin tsaka-tsaki na watanni 26.8, wannan binciken ya nuna cewa 71% na marasa lafiya masu kimantawa (n=55) sun sami cikakkiyar gafara (CR) ko CR tare da farfadowa na hematological (CRi). A cikin saitin bayanai mafi girma, matsakaiciyar rayuwa gaba ɗaya ga duk marasa lafiya waɗanda suka karɓi maɓalli masu mahimmanci (n = 78) sun fi shekaru biyu (watanni 25.4), kuma ga masu amsawa, kusan shekaru huɗu ne (watanni 47) (marasa lafiya waɗanda suka sami CR). ya da CR). Matsakaicin lokacin gafara (DOR) tsakanin marasa lafiya waɗanda za a iya kimanta ingancin su shine watanni 18.6.
The safety outcomes among the patients given Tecartus at the target dose (n=100) were consistent with the drug’s known safety profile. 25% and 32% of patients, respectively, experienced grade 3 or higher cytokine saki ciwo (CRS) and neurologic adverse events, which were typically adequately controlled.
