Cilta-Cel far don maganin myeloma da yawa

saboda an halicce shi daga fararen jinin ku waɗanda aka canza (gyara ta hanyar gado) don ganewa da lalata ƙwayoyin myeloma da yawa, Cilta-Cel CAR T-Cell far (ciltacabtagene autoleucel) ya bambanta da sauran magungunan ciwon daji da ake yawan amfani da su (kamar chemotherapy). 

Kamfanin Legend Biotech ya ce FDA ta amince da ciltacabtagene autoleucel (cilta-cel; Carvykti) a matsayin jiyya ga manya waɗanda ke fama da koma baya ko ɓarnawar myeloma da yawa waɗanda suka riga sun sami layin jiyya huɗu ko fiye, kamar mai hana proteasome, wakili na rigakafi, da anti-CD38 monoclonal antibody.

FDA ta tsawaita lokacin bita don cilta-cel, mai karɓar maganin antigen mai karɓa (CAR) T-cell tare da ƙwayoyin rigakafi guda biyu waɗanda ke nufin BCMA, daga 2021 zuwa 2023 don samun isasshen lokaci don bincika bayanan da aka ƙaddamar game da ingantaccen nazari. Hanyar da aka yi don amsa buƙatun bayanan FDA.

Yawan amsa gabaɗaya (ORR) na 98% (95% CI, 92.7%-99.7%) da stringent cikakken ƙimar amsawa (SCR) na 78% (95% CI, 68.8%-86.1%) an samu ta cilta-cel ana gudanar da shi azaman jiko ɗaya a kewayon kashi na 0.5 zuwa 1.0 x 106 CAR-tabbatacce T Kwayoyin T a kowace kilogiram na nauyin jiki a cikin gwaji na asibiti na 1/2 CARITUDE (NCT035 Kwayoyin CAR T sun haifar da ƙarfi da zurfin halayen. Tsawon tsaka-tsakin amsawar shine watanni 21.8 (95% CI, 21.8 don ba za a iya ƙididdige shi ba) a cikin tsaka-tsakin watanni na 18. 

Sundar Jagannath, MD, MBBS, farfesa a fannin likitanci, ilimin jini, da kuma ilimin likitanci a Dutsen Sinai, ya kasance babban mai binciken binciken. "Tafiya na jiyya ga yawancin marasa lafiya da ke zaune tare da myeloma mai yawa shine sake dawowa da sake dawowa tare da ƙananan marasa lafiya da ke samun amsa mai zurfi yayin da suke ci gaba ta hanyar layi na gaba," in ji shi a cikin wata sanarwa.

1) Sakamakon binciken CARTITUDE-1, wanda ya nuna cewa cilta-cel na iya haifar da amsa mai zurfi da dorewa da kuma dogon lokaci mara magani, har ma a cikin wannan yawan yawan marasa lafiya na myeloma da aka riga aka rigaya, sun burge ni saboda wannan. Yarda da Carvykti a yau ya cika buƙatu mai mahimmanci ga waɗannan marasa lafiya.

Mutanen 97 tare da sake dawowa / refractory mahara myeloma sune batun buɗaɗɗen lakabin, hannu-ɗaya, binciken CARITUDE da yawa. Adadin marasa lafiya waɗanda suka fuskanci abubuwan da ba su da kyau (AEs) da kuma yawan waɗanda suka sami AEs mai tsanani sun yi aiki a matsayin maki na ƙarshen lokaci na 1. ORR yayi aiki azaman babban matakin ƙarshe na lokaci 2. Masu binciken sunyi nazarin rayuwa ba tare da ci gaba ba (PFS), rayuwa gaba ɗaya (OS), lokaci don amsawa, matakan CAR-T sel, matakan BCMA-bayyana sel, matakan BCMA mai narkewa, ƙididdigar cytokine na tsarin, matakan BCMA, lafiya- ingancin rayuwa mai alaƙa, da canji daga asali mai alaƙa da ingancin rayuwa a matsayin maki na ƙarshe na biyu.

Kwanan nan an ba da rahoton sakamakon binciken na tsawon shekaru biyu a taron shekara-shekara na Ƙungiyar Ciwon Jiki ta Amirka. Dangane da bayanan, dangane da tasiri, lokacin tsaka-tsaki don amsawar farko shine wata 1, kuma lokacin matsakaici don kammala amsa ko mafi kyau shine watanni 2 (kewaye, 1-15). Lokacin da aka tantance kasancewar mafi ƙarancin ƙwayar cuta (MRD) a cikin marasa lafiya 57, 91.8% daga cikinsu sun gwada mara kyau. Adadin PFS shine 66.0% (95% CI, 54.9% -75.0%) kuma ƙimar OS shine 80.9% (95% CI, 71.4% -87.6%) a lokacin watanni 18. Adadin PFS shine 96.3% kuma ƙimar OS shine 100% a cikin rukunin marasa lafiya waɗanda suka ci gaba da MRD sama da watanni 6 da fiye da watanni 12. Ba a sami matsakaicin PFS ba.

2) Neutropenia (94.8%), anemia (68.0%), leukopenia (60.8%), thrombocytopenia (59.8%), da lymphopenia (49.5%) sun kasance daga cikin matakan 3/4 na hematologic m abubuwan da aka gani. 94.8% na marasa lafiya suna da ciwon saki na cytokine, wanda galibi ya faru a cikin maki 1 da 2.

Alamar da FDA ta amince da ita don cilta-cel ya ba da jerin sunayen cututtukan Guillain-Barré, ciwon neuropathy na gefe, ciwon jijiyar cranial, da lymphohistiocytosis na hemophagocytic ban da 3/4 AEs akai-akai.

FDA ta ba da ci gaba na cilta-cel da sunayen magungunan marayu kafin amincewa da shi don kula da marasa lafiya tare da relapsed ko refractory mahara myeloma wanda ya karbi hudu ko fiye kafin Lines na far. An kuma ƙaddamar da Cilta-cel don amincewa a ƙarƙashin wannan alamar a Turai.

Ta yaya Cilta-Cel CAR T-Cell far ke aiki?

Cilta-Cel therapy CAR T-cell far, ko chimeric antigen receptor magani, wani sabon nau'i ne na immunotherapy wanda ke amfani da ƙwararrun ƙwayoyin T na musamman don ƙaddamar da ƙwayoyin cutar kansa daidai. Tsarin garkuwar jiki ya ƙunshi sel da gabobin da ke aiki tare don kiyaye jiki daga kamuwa da cutar kansa. Kwayoyin T sune nau'in tantanin halitta guda ɗaya waɗanda ke farauta da kashe ƙwayoyin cuta, gami da ƙwayoyin kansa. Domin wasu lokuta ƙwayoyin kansa na iya guje wa tsarin rigakafi, ya zama dole a sake horar da tsarin rigakafi don ganewa da yaki da kwayoyin cutar kansa. CAR T-cell far wata sabuwar hanya ce ta horar da tsarin rigakafi don yaƙar kansa.

Bayan an ɗauki samfurin ƙwayoyin T marasa lafiya daga cikin jini, ana sake kera ƙwayoyin don samun takamaiman tsari akan farfajiyarsu da ake kira masu karɓar ragin antigen (CARs). Masu karɓa a kan waɗannan ƙwayoyin CAR T na iya taimakawa ƙwayoyin T don ganowa da kai hari ga ƙwayoyin cutar kansa a ko'ina cikin jiki lokacin da aka sake shigar da su cikin mai haƙuri.

CAR T-cell far yanzu an ba da lasisi ta FDA a matsayin ma'aunin kulawa na wasu nau'ikan da suka sake dawowa ko rashin ƙarfi. Lymphoma ba Hodgkin, Multi myeloma, da yara sun sake dawowa m lymphoblastic leukemia (ALL), kuma ana gwada su a cikin ƙarin nau'in ciwon daji na jini.

CAR T-Cell far shine nau'in immunotherapy wanda ke amfani da T-sel na musamman wanda aka gyara wanda ke cikin tsarin garkuwar jikin mu don yin yaƙi ciwon daji. Ana tattara samfurin kwayoyin T marasa lafiya daga jini, sannan an gyara shi don samar da sifofi na musamman da ake kira chimeric antigen receptors (CAR) a saman su. Lokacin da aka sake dawo da waɗannan ƙwayoyin CAR da aka gyara a cikin majiyyaci, waɗannan sabbin ƙwayoyin suna kai hari kan takamaiman antigen kuma suna kashe ƙwayoyin ƙari.

Menene farashin Cilta-Cel CAR T-Cell far?

A halin yanzu, Cilta-Cel CAR T-Cell far yana kusan $225,000 USD a China da $425,000 a Amurka. A halin yanzu, ana samunsa a zaɓaɓɓun cibiyoyi a cikin Amurka. Koyaya, ana gudanar da gwaje-gwaje na asibiti da yawa a China, kuma ana sa ran farashin su zai ragu sosai da zarar an amince da waɗannan sabbin gwaje-gwajen.

Abubuwan da ke haifar da Cilta-Cell CAR T-Cell far

Cilta-Cel (ciltacabtagene autoleucel) na iya haifar da lahani masu tsanani ko masu barazana ga rayuwa kuma suna iya kaiwa ga mutuwa. Kira mai ba da lafiyar ku ko samun taimakon gaggawa nan da nan idan kun sami ɗayan waɗannan masu zuwa:

• zazzabi (100.4°F/38°C ko sama)
• sanyi ko girgiza sanyi
• azumi ko rashin biyan bukatun zuciya
• wahalar numfashi
• raguwar jini sosai
• dizziness / haske kai
• illolin da ke kan tsarin jin daɗin ku, wasu daga cikinsu na iya faruwa kwanaki ko makonni bayan kun karɓi jiko kuma suna iya zama da dabara da farko, kamar:
  • jin ruɗewa, rashin faɗakarwa ko rashin fahimta, wahalar magana ko ɓacin rai, wahalar karatu, rubutu da fahimtar kalmomi, asarar ƙwaƙwalwa
  • asarar haɗin kai da ke shafar motsi da daidaituwa, ƙananan motsi, canje-canje a rubutun hannu
  • canjin hali, gami da rage ikon bayyana motsin rai, rashin yawan magana, rashin sha'awar ayyuka, da rage yanayin fuska.
  • tingling, numbness da zafi a hannaye da ƙafafu, wahalar tafiya, ƙafa da / ko rauni na hannu, da wahalar numfashi
  • kumburin fuska, wahalar motsa tsokar fuska da idanu

Cilta-Cel CAR T-Cell far a China

Mahukuntan kasar Sin sun ba da matsayin ci gaba na farfadowa ga Legend Biotech da Janssen na binciken CAR T-cell therapy, ciltacabtagene autoleucel (cilta-cel), a matsayin yuwuwar jiyya don sake dawowa ko ɓarna mahara myeloma.

Cilta-cel yana nufin duka JNJ-4528, wanda shine sunan da ake gane maganin a wajen kasar Sin, da LCAR-B38M, wanda shine sunan da aka san shi a kasar Sin.

Shawarar Cibiyar Nazarin Magunguna ta kasar Sin (CDE) ta Hukumar Kula da Kayayyakin Kiwon Lafiyar Jama'a (NMPA) an yi niyya ne don hanzarta ci gaba da nazarin jiyya tare da shaidar farko ta asibiti na alƙawarin girma fiye da jiyya na yau da kullun na cututtukan cututtuka.

A cewar sanarwar manema labarai daga Legend, Shugaba Frank Zhang, PhD, "Nasarar da aka ba da shawarar da CDE ta kasar Sin ta NMPA ta nuna yana nuna muhimmin ci gaba mai mahimmanci a ci gaban ci gaban cilta-cel a cikin marasa lafiya na myeloma da yawa."

Ya ci gaba da cewa, "Legend za ta ci gaba da yin nazarin wannan magani na bincike a kasar Sin da kasashen waje tare da Janssen.

Maganin a baya yana riƙe da takardar shedar PRIME (Maganin Farko) daga Hukumar Kula da Magunguna ta Turai don nuni iri ɗaya da naɗin jiyya daga Hukumar Abinci da Magunguna ta Amurka. Hukumomin gudanarwa a cikin Amurka, EU, Japan, da Koriya suma sun sanya shi azaman maganin marayu.