Maris 2022: A cewar Johnson & Johnson, wani maganin da kamfanin da abokin aikin sa na kasar Sin suka samar Kudin hannun jari Legend Biotech Corp Hukumar Abinci da Magunguna ta Amurka ta amince da maganin wani nau'in ciwon daji na farin jini.
Shawarar da FDA ta yanke ya share hanyar da za a amince da samfurin farko na Legend a Amurka, a daidai lokacin da hukumar ta kara yawan binciken gwajin magunguna da aka yi a China. An fara gwada maganin Legend-J&J a China, sannan a Amurka da Japan.
Magani, Carvykti/Cilta-cel, na cikin nau'in magungunan da aka sani da CAR-T therapies, ko chimeric antigen receptor T-cell therapies. CAR-T medicines work by extracting and genetically modifying a patient’s own disease-fighting T-cells to target specific proteins on cancer cells, then replacing them to seek out and attack cancer.
Legend da J&J za su sayar da maganin a Greater China a 70-30 raba riba, kuma a duk sauran ƙasashe a cikin 50-50 raba riba.
Fabrairu 28, 2022-Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), wani kamfani na fasahar kere-kere na duniya da ke haɓakawa, kerawa da sayar da sabbin hanyoyin kwantar da hankali don magance cututtukan da ke barazanar rayuwa, a yau sun sanar da cewa Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da samfurin farko nata, CARVYKTI ™ (ciltacabtagene autoleucel; ciltacel), don maganin cutar manya tare da relapsed ko refractory mahara myeloma (RRMM) waɗanda suka sami hudu ko fiye da kafin layukan far, ciki har da proteasome inhibitor, immunomodulatory wakili, da anti-CD38 monoclonal antibody. Legend Biotech ya shiga keɓantaccen lasisi na duniya da yarjejeniyar haɗin gwiwa tare da Janssen Biotech, Inc. (Janssen) don haɓakawa da tallata ciltacel a cikin Disamba 2017.
CARVYKTITM shine chimeric antigen receptor T-cell (CAR-T) far tare da antigen B-cell maturation antigen (BCMA) guda biyu.
ƙwayoyin rigakafi kuma an ba su azaman jiko na lokaci ɗaya tare da shawarar adadin adadin 0.5 zuwa 1.0 x 106 CAR-tabbatacce T Kwayoyin T da kilogiram na nauyin jiki. A cikin binciken CARTITUDE-1 mai mahimmanci, an sami amsa mai zurfi da dorewa a cikin marasa lafiya tare da RRMM (n = 97), tare da babban adadin amsa gabaɗaya (ORR) na 98 bisa dari (95% tazarar amincewa [CI]: 92.7-99.7) ciki har da Kashi 78 cikin dari na marasa lafiya suna samun nasara sosai
cikakken amsa (sCR, 95 bisa dari CI: 68.8-86.1).
1 A matsakaicin watanni na watanni 18, tsawon lokaci na amsawa (DOR) shine watanni 21.8 (95 bisa dari CI 21.8-ba ƙididdiga ba).
1
CARVYKTI™ yana samuwa ne kawai ta hanyar ƙayyadaddun shirin a ƙarƙashin Ƙididdigar Haɗari da Dabarun Rage Hatsari (REMS) da ake kira CARVYKTI™
Shirin REMS.1 Bayanin Tsaro na CARVYKTI™ ya haɗa da Gargaɗi na Akwati game da Ciwon Sakin Cytokine (CRS), Immune
Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism da Guillain-Barré ciwo, hemophagocytic
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), da kuma tsawaitawa da/ko cytopenia mai maimaitawa.
1 Gargaɗi da Hattara
sun hada da cytopenia na tsawon lokaci da kuma maimaituwa, cututtuka, hypogammaglobulinemia, halayen rashin hankali, cututtuka na biyu da kuma
illolin iya tuƙi da amfani da inji.
1 Mafi yawan halayen rashin lafiya (≥20 bisa dari) sune pyrexia, CRS,
hypogammaglobulinemia, hypotension, musculoskeletal zafi, gajiya, cututtuka-pathogen unpecified, tari, sanyi, zawo, tashin zuciya, encephalopathy, rage ci, babba numfashi fili kamuwa da cuta, ciwon kai, tachycardia, dizziness, dyspnea, edema, hoto ko bidiyo mai zagaya yanar gizo da sauri cututtuka, coagulopathy, maƙarƙashiya, da kuma amai.
"Yawancin myeloma ya kasance cutar da ba za a iya warkewa ba tare da marasa lafiya da aka riga aka yi musu magani da yawa suna fuskantar rashin fahimta tare da iyakacin zaɓuɓɓukan magani," in ji Ying Huang, PhD, Shugaba da CFO na Legend Biotech. “Yau yarda da CARVYKTI lokaci ne mai mahimmanci ga Legend Biotech saboda shi
amincewar tallarmu ta farko ce, amma abin da ke burge mu da gaske shine yuwuwar maganin ta zama zaɓin jiyya mai tasiri ga marasa lafiya da ke buƙatar dogon lokaci mara magani. Wannan shi ne na farko daga cikin yawancin hanyoyin kwantar da tarzoma da muke shirin kawo wa marasa lafiya yayin da muke ci gaba da ciyar da bututunmu gaba a jihohin cututtuka.”
Multiple myeloma yana shafar wani nau'in farin jini mai suna plasma cells, wanda ake samu a cikin kasusuwa.2 Yawancin marasa lafiya.
koma bayan jiyya na farko da fuskantar rashin tabbas bayan jiyya tare da manyan nau'ikan magunguna guda uku, gami da
immunomodulatory wakili, mai hana proteasome da anti-CD38 monoclonal antibody.3,4,5
"Tafiya na jiyya ga mafi yawan marasa lafiya da ke zaune tare da myeloma mai yawa shine tsarin sake dawowa da sake dawowa tare da marasa lafiya marasa lafiya da ke samun amsa mai zurfi yayin da suke ci gaba ta hanyar layi na baya," in ji Dokta Sundar Jagannath, MBBS, Farfesa na Medicine, Hematology da Oncology na Likita a Dutsen Sinai, da babban mai binciken binciken. "Wannan shine dalilin da ya sa na yi matukar farin ciki game da sakamakon daga binciken CARTITUDE-1, wanda ya nuna cewa cilta-cel na iya ba da amsa mai zurfi da dorewa da kuma dogon lokaci.
tazara marasa magani, ko da a cikin wannan ɗimbin majinyata na myeloma da aka riga aka yi masa yawa. Amincewa da CARVYKTI na yau yana taimakawa wajen magance babban buƙatu ga waɗannan marasa lafiya. ”
A matsayin keɓaɓɓen magani, gwamnatin CARVYKTI™ na buƙatar horo mai yawa, shirye-shirye, da takaddun shaida don tabbatar da ƙwarewar marassa lafiya. Ta hanyar tsarin da aka tsara, Legend da Janssen za su kunna iyakataccen hanyar sadarwa na cibiyoyin jiyya kamar
suna aiki don haɓaka ƙarfin samarwa da haɓaka wadatar CARVYKTI ™ a ko'ina cikin Amurka a cikin 2022 da bayan haka, suna tabbatar da cewa za a iya ba da maganin CARVYKTI ™ ga likitocin oncologists da majiyyatan su a cikin abin dogaro da kan lokaci.
Game da CARVYKTI ™ (Ciltacabtagene autoleucel; cilta-cel) CARVYKTI ™ jagora ne na BCMA, ingantaccen tsarin rigakafi na T-cell mai sarrafa kansa, wanda ya haɗa da sake tsara sel T na majiyyaci tare da transgene mai ɓoye mai karɓar antigen na chimeric (CAR) wanda ke ganowa kuma yana kawar da shi. Kwayoyin da ke bayyana BCMA. An bayyana BCMA da farko a saman ƙwayoyin ƙwayoyin cuta na myeloma B, da kuma ƙwayoyin B-tsage-tsalle da ƙwayoyin plasma. Sunan furotin CARVYKTI™ CAR yana da ƙayyadaddun ƙwayoyin rigakafin yanki guda biyu masu niyya BCMA waɗanda aka tsara don ba da babbar fa'ida ga BCMA na ɗan adam. Bayan dauri zuwa
Kwayoyin bayyana BCMA, CAR tana haɓaka kunnawa T-cell, haɓakawa, da kawar da sel masu manufa.
A cikin Disamba 2017, Legend Biotech Corporation ya shiga cikin keɓantaccen lasisi na duniya da yarjejeniyar haɗin gwiwa tare da Janssen Biotech, Inc. don haɓakawa da tallata cilta-cel.
A cikin Afrilu 2021, Legend ya ba da sanarwar ƙaddamar da Aikace-aikacen Izinin Talla ga Hukumar Kula da Magunguna ta Turai don neman amincewar cilta-cel don kula da marasa lafiya tare da sake dawowa da/ko myeloma da yawa. Baya ga Zayyana Nazari na Farko na Amurka da aka bayar a cikin Disamba 2019, cilta-cel ta sami Nasarar Nazari na Farko a China a watan Agusta 2020. .
Game da Karatun CARTITUDE-1
CARTITUDE-1 (NCT03548207) wani mataki ne mai gudana na 1b/2, alamar buɗewa, hannu ɗaya, gwaji na tsakiya da yawa wanda ke kimanta cilta-cel don kula da marasa lafiya marasa lafiya tare da sake dawowa ko refractory mahara myeloma, wanda a baya ya karɓi aƙalla layi uku da suka gabata. na jiyya ciki har da proteasome inhibitor (PI), wani immunomodulatory wakili (IMiD) da kuma anti-CD38 monoclonal antibody. Daga cikin marasa lafiya 97 da suka yi rajista a cikin
gwaji, kashi 99 cikin 88 sun ƙi zuwa layin ƙarshe na jiyya kuma kashi 38 sun kasance masu jujjuya aji uku, ma'ana ciwon daji bai amsa ba, ko kuma ba ya amsawa, zuwa IMiD, PI da anti-CD1 monoclonal antibody.XNUMX
Ana kimanta inganci na tsawon lokaci da bayanin martaba na cilta-cel a cikin binciken CARTITUDE-1 mai gudana, tare da sakamakon biyo bayan shekaru biyu da aka gabatar kwanan nan a ASH 2021.6
Game da Myeloma da yawa
Multiple myeloma ciwon daji ne na jini wanda ba zai iya warkewa ba wanda ke farawa a cikin kasusuwan kasusuwa kuma yana da girma da yawa na ƙwayoyin plasma.
A cikin 2022, an kiyasta cewa fiye da mutane 34,000 za su kamu da cutar myeloma mai yawa, kuma fiye da mutane 12,000 za su kamu da cutar.
mutu daga cutar a Amurka
7 Yayin da wasu marasa lafiya tare da myeloma masu yawa ba su da alamun bayyanar cututtuka, yawancin marasa lafiya ana gano su saboda
alamomin da zasu iya haɗawa da matsalolin kashi, ƙarancin ƙididdiga na jini, hawan calcium, matsalolin koda ko cututtuka.
8 Ko da yake jiyya na iya
haifar da gafara, rashin alheri, majiyyata za su iya komawa baya.
3 Marasa lafiya waɗanda suka sake komawa bayan jiyya tare da daidaitattun hanyoyin kwantar da hankali, gami da masu hana protease, wakilai na immunomodulatory, da anti-CD38 monoclonal antibody, suna da ƙarancin tsinkaya da ƴan zaɓuɓɓukan magani da ake samu.
CARVYKTI™ Muhimman Bayanan Tsaro ALAMOMIN DA AMFANI
CARVYKTI ™ (ciltacabtagene autoleucel) shine antigen B-cell maturation antigen (BCMA) - wanda aka canza ta hanyar ƙwayoyin cuta ta T cell immunotherapy wanda aka nuna don kula da manya marasa lafiya tare da sake dawo da myeloma da yawa, bayan layin jiyya huɗu ko fiye da suka gabata, gami da proteasome mai hanawa, wakili na immunomodulatory, da anti-CD38 monoclonal antibody.
GARGAƊI: CUTAR SAUKI NA CYTOKINE, CUTAR CUTAR JINI, HLH/MAS, da Ɗaukaka da Maimaituwa.
CYTOPENIA
• Ciwon Saki na Cytokine (CRS), gami da halayen mutuwa ko barazanar rayuwa, sun faru a cikin marasa lafiya bayan jiyya tare da
CARVYKTI™. Kar a ba da CARVYKTI™ ga marasa lafiya da ke fama da kamuwa da cuta ko kumburi. Bi da CRS mai tsanani ko mai barazanar rai tare da tocilizumab ko tocilizumab da corticosteroids.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), wanda zai iya zama mai kisa ko barazanar rai, ya faru biyo baya.
jiyya tare da CARVYKTI™, gami da kafin fara CRS, tare da CRS, bayan ƙudurin CRS, ko kuma in babu CRS. Saka idanu don abubuwan da suka faru na neurologic bayan jiyya tare da CARVYKTI™. Bada kulawar tallafi da/ko corticosteroids kamar yadda ake buƙata.
• Cutar Parkinsonism da Guillain-Barré ciwo da rikice-rikicen da ke tattare da su wanda ke haifar da halayen mutuwa ko barazanar rai
ya faru biyo bayan jiyya tare da CARVYKTI™.
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), gami da halayen mutuwa da masu barazanar rai,
ya faru a cikin marasa lafiya bayan jiyya tare da CARVYKTI™. HLH/MAS na iya faruwa tare da CRS ko cututtukan neurologic.
• Tsawaitawa da/ko cytopenia mai maimaitawa tare da zub da jini da kamuwa da cuta da kuma buƙatu don dashen kwayar halitta don hematopoietic.
farfadowa ya faru bayan jiyya tare da CARVYKTI™.
• CARVYKTI™ yana samuwa ne kawai ta hanyar ƙayyadaddun shiri a ƙarƙashin Ƙididdigar Haɗari da Dabarun Rage Hatsari (REMS) da ake kira Shirin CARVYKTI™ REMS.
WARNINGS DA ZUWA
Ciwon Saki na Cytokine (CRS) wanda ya haɗa da halayen mutuwa ko masu barazanar rai, sun faru bayan jiyya tare da CARVYKTI™ a cikin 95% (92/97) na marasa lafiya da ke karɓar ciltacabtagene autoleucel. Mataki na 3 ko mafi girma CRS (2019 ASTCT grade)1 ya faru a cikin 5% (5/97) na marasa lafiya, tare da Grade 5 CRS da aka ruwaito a cikin majiyyaci 1. Tsakanin lokacin fara CRS shine kwanaki 7 (kewaye: kwanaki 1-12). Mafi yawan bayyanar cututtuka na CRS sun hada da pyrexia (100%), hypotension (43%), karuwar aspartate aminotransferase (AST) (22%), sanyi (15%), ƙarar alanine aminotransferase (14%) da sinus tachycardia (11%). . Matsayi na 3 ko mafi girma abubuwan da ke da alaƙa da CRS sun haɗa da ƙarar AST da ALT, hyperbilirubinemia, hypotension, pyrexia, hypoxia, gazawar numfashi, mummunan rauni na koda, yaduwa na intravascular.
coagulation, HLH/MAS, angina pectoris, supraventricular da ventricular tachycardia, malaise, myalgias, ƙara C-reactive protein, ferritin, jini alkaline phosphatase da gamma-glutamyl transferase.
Gano CRS dangane da gabatarwar asibiti. Yi la'akari da kuma magance wasu abubuwan da ke haifar da zazzabi, hypoxia, da hypotension. An ba da rahoton cewa CRS yana da alaƙa da binciken HLH/MAS, kuma ilimin ilimin halittar ɗan adam na iya haɗuwa. HLH/MAS abu ne mai yuwuwar barazanar rayuwa
yanayi. A cikin marasa lafiya tare da alamun ci gaba na CRS ko CRS mai juyayi duk da jiyya, kimantawa don shaidar HLH/MAS. Sittin da tara na 97 (71%) marasa lafiya sun karɓi tocilizumab da/ko corticosteroid don CRS bayan jiko na ciltacabtagene autoleucel. Arba'in da hudu
(45%) marasa lafiya sun karbi tocilizumab kawai, wanda 33 (34%) ya karbi kashi daya kuma 11 (11%) sun karbi fiye da kashi ɗaya; 24 marasa lafiya (25%) sun karbi tocilizumab da corticosteroid, kuma daya mai haƙuri (1%) ya karbi kawai corticosteroids. Tabbatar cewa ana samun mafi ƙarancin allurai biyu na tocilizumab kafin jiko na CARVYKTI™.
Kula da marasa lafiya aƙalla yau da kullun na kwanaki 10 bayan jiko na CARVYKTI™ a wurin kiwon lafiya da aka tabbatar da REMS don alamu da alamun CRS. Kula da marasa lafiya don alamun ko alamun CRS na akalla makonni 4 bayan jiko. A farkon alamar CRS, nan da nan kafa jiyya tare da kulawar tallafi, tocilizumab, ko tocilizumab da corticosteroids. Shawarci marasa lafiya da su nemi kulawar likita nan take ya kamata alamu ko alamun CRS su faru a kowane lokaci. Magungunan ƙwayoyin cuta, waɗanda ke iya zama mai tsanani, masu barazanar rai ko kuma mai kisa, sun faru ne bayan jiyya tare da CARVYKTI™. Abubuwan da ke haifar da cutar neurologic sun haɗa da ICANS, ƙwayar cuta ta neurologic tare da alamu da alamun cututtukan Parkinsonism, Guillain-Barré Syndrome, neuropathies na gefe, da ciwon jijiyoyi na cranial. Nasiha ga majiyyata akan alamomi da alamun waɗannan cututtukan cututtukan neurologic, da kuma jinkirin yanayin farawa.
wasu daga cikin wadannan guba. Umurci marasa lafiya da su nemi kulawar likita nan da nan don ƙarin ƙima da gudanarwa idan alamu ko alamun kowane ɗayan waɗannan cututtukan ƙwayoyin cuta sun faru a kowane lokaci.
Gabaɗaya, ɗaya ko fiye da nau'ikan cututtukan cututtukan ƙwayoyin cuta da aka bayyana a ƙasa sun faru bayan ciltacabtagene autoleucel a cikin 26% (25/97) na marasa lafiya, wanda 11% (11/97) na marasa lafiya sun sami digiri na 3 ko abubuwan da suka fi girma. An kuma lura da waɗannan nau'o'in nau'ikan cututtukan neurologic a cikin binciken guda biyu masu gudana.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): ICANS ya faru a cikin 23% (22/97) na marasa lafiya da ke karɓar ciltacabtagene autoleucel ciki har da Grade 3 ko 4 abubuwan da suka faru a cikin 3% (3/97) da Grade 5 (m) abubuwan da suka faru a cikin 2% (2/97). Matsakaicin lokacin fara ICANS shine kwanaki 8 (kewayon kwanaki 1-28). Duk marasa lafiya 22 da ke da ICANS suna da CRS. Mafi yawan bayyanar (≥5%) na bayyanar ICANS sun haɗa da ciwon hauka
(23%), aphasia (8%) da ciwon kai (6%). Kula da marasa lafiya aƙalla yau da kullun na kwanaki 10 bayan jiko na CARVYKTI™ a cibiyar kiwon lafiya ta REMS don alamu da alamun ICANS. Kashe wasu dalilai na alamun ICANS. Kula da marasa lafiya don alamun ko alamun ICANS na akalla makonni 4 bayan jiko kuma a yi magani da sauri. Ya kamata a gudanar da ƙwayar cutar ta jiki tare da kulawa mai tallafi da / ko corticosteroids kamar yadda ake bukata.
Parkinsonism: Daga cikin marasa lafiya na 25 a cikin binciken CARTITUDE-1 da ke fuskantar kowane nau'in neurotoxicity, marasa lafiya maza biyar suna da cututtukan neurologic tare da alamu da alamun bayyanar cututtuka na parkinsonism, daban-daban daga ciwon ƙwayar cutar neurotoxicity (ICANS). Kwayoyin cuta
An ba da rahoton guba tare da parkinsonism a cikin wasu gwaje-gwajen da ke gudana na ciltacabtagene autoleucel. Marasa lafiya suna da alamun Parkinsonian da marasa lafiya waɗanda suka haɗa da rawar jiki, bradykinesia, motsi na son rai, stereotypy, asarar motsi na kwatsam, abin rufe fuska, rashin tausayi, tasiri mai lebur, gajiya, tsauri, jinkirin psychomotor, micrographia, dysgraphia, apraxia, lethargy, rudani, somnolence.
asarar sani, jinkirin ra'ayi, hyperreflexia, asarar ƙwaƙwalwar ajiya, wahalar haɗiye, rashin daidaituwa na hanji, faduwa, matsananciyar matsayi, rawar jiki, rauni na tsoka da ɓata, rashin aikin motsa jiki, motar motsa jiki da hasara mai hankali, maye gurbi, da alamun sakin gaba na lobe.
Matsakaicin farawa na parkinsonism a cikin marasa lafiya 5 a cikin CARTITUDE-1 shine kwanaki 43 (kewayon 15-108) daga jiko na ciltacabtagene autoleucel.
Kula da marasa lafiya don alamun da alamun fakinsonism waɗanda ƙila a jinkirta farawa kuma ana sarrafa su tare da matakan kulawa.
Akwai taƙaitaccen bayanin inganci tare da magungunan da ake amfani da su don maganin cutar ta Parkinson, don haɓakawa ko ƙuduri
bayyanar cututtuka na parkinsonism bayan maganin CARVYKTI™.
Ciwon Guillain-Barré: Wani sakamako mai mutuwa bayan Guillain-Barré Syndrome (GBS) ya faru a wani binciken da ke gudana
ciltacabtagene autoleucel duk da jiyya tare da immunoglobulins na jijiya. Alamomin da aka ruwaito sun haɗa da waɗanda suka yi daidai da bambancin MillerFisher na GBS, ciwon hauka, raunin motsi, rikicewar magana da polyradiculoneuritis.
Saka idanu don GBS. Yi la'akari da marasa lafiya da ke nunawa tare da neuropathy na gefe don GBS. Yi la'akari da jiyya na GBS tare da matakan kulawa na tallafi da haɗin gwiwa tare da immunoglobulins da musayar jini, dangane da tsananin GBS.
Neuropathy na Peripheral: Marasa lafiya shida a cikin CARTITUDE-1 sun haɓaka neuropathy na gefe. Waɗannan cututtukan neuropathy waɗanda aka gabatar a matsayin masu jijiyoyi, motsa jiki ko na'urori masu jijiyoyi. Matsakaicin lokacin fara bayyanar cututtuka shine kwanaki 62 (kewayon kwanaki 4-136), tsawon lokaci na tsaka-tsakin neuropathy na gefe shine kwanaki 256 (kewayon 2-465 kwanaki) ciki har da waɗanda ke da neuropathy mai gudana. Marasa lafiya waɗanda suka ɗanɗana neuropathy na gefe suma sun sami ciwon jijiyoyi na cranial ko GBS a cikin wasu gwaje-gwajen da ke gudana na ciltacabtagene autoleucel.
Cranial Nerve Palsies: Marasa lafiya uku (3.1%) sun sami ciwon jijiyoyi a cikin CARTITUDE-1. Duk marasa lafiya uku suna da jijiyar cranial na 7
palsy; daya majiyyaci yana da ciwon cranial jijiyoyi na 5 kuma. Matsakaicin lokacin farawa shine kwanaki 26 (kewayon kwanaki 21-101) bayan jiko na
ciltacabtagene autoleucel. Halin na 3rd da 6th cranial palsy na jijiyoyi, biyu na 7th cranial jijiyar jijiyoyi, daɗaɗɗen jijiyar jijiyar cranial bayan ingantawa, da kuma abin da ya faru na neuropathy na gefe a cikin marasa lafiya da ciwon daji na cranial kuma an ruwaito su a cikin gwaje-gwaje masu gudana.
ciltacabtagene autoleucel. Kula da marasa lafiya don alamun da alamun cututtukan jijiyoyi na cranial. Yi la'akari da gudanarwa tare da tsarin corticosteroids, dangane da tsanani da ci gaban alamu da bayyanar cututtuka. Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS: Fatal HLH ya faru a cikin majiyyaci ɗaya (1%), 99
kwanaki bayan ciltacabtagene autoleucel. An gabatar da taron HLH da tsawaitawar CRS na kwanaki 97. Bayanin HLH/MAS
sun hada da hauhawar jini, hypoxia tare da lalata alveolar lalacewa, coagulopathy, cytopenia, da rashin aikin gabobin jiki da yawa, gami da rashin aikin koda. HLH yanayi ne mai barazanar rai tare da yawan mace-mace idan ba a gane shi ba kuma a yi masa magani da wuri. Ya kamata a gudanar da jiyya na HLH/MAS bisa ga ƙa'idodin hukumomi. CARVYKTI™ REMS: Saboda haɗarin CRS da cututtukan cututtukan ƙwayar cuta, CARVYKTI™ yana samuwa ne kawai ta hanyar ƙayyadaddun shirin a ƙarƙashin Tsarin Haɗari da Rage Hatsari (REMS) da ake kira CARVYKTI™ REMS.
Ana samun ƙarin bayani a www.CARVYKTIrems.com ko 1-844-672-0067.
Tsawaitawa da Maimaituwar Cytopenias: Marasa lafiya na iya nuna tsawaitawa da maimaita cytopenias biyo bayan chemotherapy lymphodepleting da CARVYKTI™ jiko. Ɗaya daga cikin majiyyaci ya yi maganin ƙwayar ƙwayar cuta ta autologous don gyaran hematopoietic saboda tsawan lokaci thrombocytopenia.
A cikin CARTITUDE-1, 30% (29/97) na marasa lafiya sun sami dogon lokaci na Grade 3 ko 4 neutropenia da 41% (40/97) na marasa lafiya sun sami tsawan Grade 3 ko 4 thrombocytopenia wanda ba a warware ta ranar 30 bayan cittacabtagene autoleucel jiko.
Matsayi na 3 ko 4 mai maimaitawa neutropenia, thrombocytopenia, lymphopenia da anemia an gani a cikin 63% (61/97), 18% (17/97), 60% (58/97),
da 37% (36/97) bayan murmurewa daga matakin farko na 3 ko 4 cytopenia bin jiko. Bayan Rana 60 bin ciltacabtagene autoleucel
jiko, 31%, 12% da 6% na marasa lafiya sun sake dawowa na Grade 3 ko mafi girma lymphopenia, neutropenia da thrombocytopenia, bi da bi, bayan da farko dawo da su Grade 3 ko 4 cytopenia. Kashi tamanin da bakwai (84/97) na marasa lafiya suna da ɗaya, biyu, ko uku ko fiye
sake dawowa na cytopenia na Grade 3 ko 4 bayan farkawa na cytopenia na Grade 3 ko 4. Marasa lafiya shida da 11 sun sami Grade 3 ko 4 neutropenia da thrombocytopenia, bi da bi, a lokacin mutuwa.
Kula da ƙididdigar jini kafin da bayan jiko na CARVYKTI™. Sarrafa cytopenia tare da abubuwan haɓakawa da tallafin ƙarin ƙarin jini bisa ga jagororin cibiyoyi na gida.
Kamuwa da cuta: CARVYKTI™ bai kamata a gudanar da shi ga marasa lafiya da ke fama da kamuwa da cuta ko ciwon kumburi ba. Mummunan cututtuka masu haɗari, masu barazanar rai ko kuma na mutuwa sun faru a cikin marasa lafiya bayan jiko na CARVYKTI™.
Cututtuka (duk maki) sun faru a cikin marasa lafiya 57 (59%). Kwayoyin cututtuka na 3 ko 4 sun faru a cikin 23% (22/97) na marasa lafiya; Kwayoyin cututtuka na digiri 3 ko 4 tare da kwayoyin cutar da ba a bayyana ba sun faru a cikin 17%, cututtuka na hoto a cikin 7%, cututtuka na kwayoyin cuta a cikin 1%, da cututtukan fungal a cikin 1% na marasa lafiya.
Gabaɗaya, marasa lafiya huɗu suna da cututtukan Grade 5: ƙurar huhu (n=1), sepsis (n=2) da ciwon huhu (n=1).
Kula da marasa lafiya don alamun da alamun kamuwa da cuta kafin da bayan jiko na CARVYKTI da kuma kula da marasa lafiya yadda ya kamata. Gudanar da prophylactic, pre-emptive da/ko magungunan kashe kwayoyin cuta bisa ga daidaitattun jagororin cibiyoyi. Febrile neutropenia ya kasance
ana lura da shi a cikin 10% na marasa lafiya bayan jiko na ciltacabtagene autoleucel, kuma yana iya kasancewa tare da CRS. A cikin yanayin neutropenia na febrile, ƙididdige kamuwa da cuta kuma sarrafa tare da maganin rigakafi masu yawa, ruwaye da sauran kulawar tallafi, kamar yadda likita ya nuna.
Maimaita Kwayar cuta: Maimaita cutar Hepatitis B (HBV), a wasu lokuta yana haifar da fulminant hepatitis, gazawar hanta da mutuwa, na iya faruwa a cikin marasa lafiya da hypogammaglobulinemia. Yi bincike don Cytomegalovirus (CMV), HBV, cutar hanta C (HCV), da ƙwayar cuta ta rigakafi ta mutum (HIV), ko duk wani nau'in cututtuka idan an nuna su ta asibiti daidai da jagororin asibiti kafin tarin sel don masana'antu. Yi la'akari da maganin ƙwayar cuta don hana sake kunnawa ta hoto ta hanyar jagororin cibiyoyi na gida/aiki na asibiti.
An ba da rahoton Hypogammaglobulinemia a matsayin mummunan lamari a cikin 12% (12/97) na marasa lafiya; Matakan IgG na dakin gwaje-gwaje sun faɗi ƙasa da 500 mg/dL bayan jiko a cikin 92% (89/97) na marasa lafiya. Kula da matakan immunoglobulin bayan jiyya tare da CARVYKTI™ da gudanar da IVIG don IgG
<400 mg/dL. Sarrafa kowane jagororin cibiyoyi na gida, gami da matakan kariya daga kamuwa da cuta da ƙwayoyin cuta ko rigakafi na rigakafi.
Amfani da Alurar Rayayyun: Ba a yi nazarin amincin rigakafi tare da maganin rigakafi masu rai ba yayin ko bin maganin CARVYKTI™.
Ba a ba da shawarar yin allurar rigakafin ƙwayoyin cuta masu rai na aƙalla makonni 6 kafin fara aikin chemotherapy na lymphodepleting, yayin jiyya na CARVYKTI™, kuma har sai an dawo da rigakafi bayan jiyya tare da CARVYKTI™.
Hannun Hannun Hannun Hannu sun faru a cikin 5% (5/97) na marasa lafiya biyo bayan jiko na ciltacabtagene autoleucel. Mummunan halayen hawan jini, gami da anaphylaxis, na iya kasancewa saboda dimethyl sulfoxide (DMSO) a cikin CARVYKTI™. Ya kamata a kula da marasa lafiya a hankali na tsawon sa'o'i 2 bayan jiko don alamun da bayyanar cututtuka mai tsanani. Yi magani da sauri kuma sarrafa yadda ya kamata gwargwadon tsananin rashin hankali.
Malignancin Sakandare: Marasa lafiya na iya haɓaka malignancies na biyu. Saka idanu tsawon rayuwa don rashin lafiya na biyu. Idan rashin lafiya ta biyu ta faru, tuntuɓi Janssen Biotech, Inc., a 1-800-526-7736 don bayar da rahoto da samun umarni kan tarin
samfurori masu haƙuri don gwada rashin lafiyar sakandare na asalin T cell.
Tasiri kan Ikon Tuƙi da Amfani da Injinan: Saboda yuwuwar abubuwan da ke faruwa na neurologic, gami da canjin yanayin tunani, rikice-rikice, raguwar neurocognitive, ko neuropathy, marasa lafiya suna cikin haɗari don canzawa ko rage hankali ko daidaitawa a cikin makonni 8 masu zuwa.
CARVYKTI™ jiko. Shawarci marasa lafiya da su guji tuƙi da shiga ayyuka ko ayyuka masu haɗari, kamar yin aiki mai nauyi ko yuwuwar injuna a wannan lokacin na farko, da kuma yayin da sabon farkon kowane cututtukan ƙwayoyin cuta.
SHA'AWAR SHA'AWA
Mafi yawan abubuwan da ba a cikin dakin gwaje-gwaje ba (abin da ya faru fiye da 20%) shine pyrexia, ciwon saki na cytokine, hypogammaglobulinemia, hypotension, zafi na musculoskeletal, gajiya, cututtuka na pathogen da ba a bayyana ba, tari, sanyi, zawo, tashin zuciya, encephalopathy, rage yawan ci. ciwon kai, tachycardia, dizziness, dyspnea, edema, viral cututtuka, coagulopathy, maƙarƙashiya, da amai. Mafi yawan halayen halayen dakin gwaje-gwaje (abin da ya fi girma ko daidai da 50%) sun haɗa da thrombocytopenia, neutropenia, anemia, hawan aminotransferase, da hypoalbuminemia.
Don Allah a karanta Cikakken Bayanin Rubutu gami da Gargadin Akwati don CARVYKTI™.
