Luulyo 2023: Maamulka Cuntada iyo Dawooyinka ayaa siisay oggolaan degdeg ah epcoritamab-bysp (Epkinly, Genmab US, Inc.) dib u soo noqoshada ama dib u soo celinta unugyada B-cell lymphoma (DLBCL) ee aan si kale loo cayimin, oo ay ku jiraan DLBCL oo ka timaadda lymfoma indolent, iyo heerka sare ee B-cell lymphoma ka dib laba ama in ka badan oo daawaynta habdhiska ah.
Epcoritamab-bysp, CD20-ku-hagaaji CD3 T-unugga, ayaa lagu tijaabiyay EPCORE NHL-1 (NCT03625037), calaamad furan, koox-kooxeedyo badan, xarun-badan, hal-gacan ah oo daraasad lagu sameeyay bukaan-socodka dib-u-celinta ama dib-u-kicinta B-cell lymphoma. Dadka waxtarka leh waxay ka kooban yihiin 148 bukaan oo qaba dib u soo noqoshada DLBCL, oo aan si kale loo cayimin, oo ay ku jiraan DLBCL oo ka timid lymphoma indolent iyo heerka sare ee B-cell lymphoma, ka dib laba ama in ka badan oo daawaynta nidaamka, oo ay ku jiraan ugu yaraan hal anti-CD20 monoclonal antibody-ka ku jira daaweynta.
Guddiga Dib u Eegista Madaxbanaan waxay adeegsadeen shuruudaha Lugano 2014 si ay u ogaadaan heerka jawaabta guud (ORR), kaas oo ahaa cabirka ugu muhiimsan ee waxtarka. ORR wuxuu ahaa 61% (95% CI: 53-69), iyo 38% bukaannada ayaa yeeshay falcelin dhammaystiran. Iyadoo la raacayo dhexdhexaadinta bilaha 9.8 ee jawaabeyaasha, muddada jawaabta dhexdhexaadka ah ee la saadaaliyay (DOR) waxay ahayd 15.6 bilood (95% CI: 9.7, lama gaarin).
The prescription information has a Boxed Warning about cytokine sii daayo syndrome (CRS), which can be serious or even kill you, and immune effector cell-associated neurotoxicity syndrome (ICANS), which can also be serious or kill you. Among the warnings and measures, infections and cytopenias are mentioned. 51% of the 157 people with relapsed or refractory large B-cell qanjiro who took the suggested dose of epcoritamab-bysp had CRS, 6% had ICANS, and 15% had serious infections. 37% of people with CRS had Grade 1, 17% had Grade 2, and 2.5% had Grade 3. 4.5% of ICANS cases were Grade 1, 1.3% were Grade 2, and 0.6% were Grade 5.
Epcoritamab-bysp waa in uu bixiyaa kaliya shaqaale caafimaad oo tababaran oo haysta taageerada caafimaad ee saxda ah si uu ula tacaalo falcelinta halista ah sida CRS iyo ICANS. Sababtoo ah fursada CRS iyo ICANS, dadka qaata 48 mg maalinta 15 ee wareegga 1 waa inay joogaan isbitaalka 24 saacadood.
Dhibaatooyinka soo raaca ee dhaca inta badan (qiyaastii 20%) waxay ahaayeen CRS, daal, xanuun murqaha iyo kala-goysyada, falcelinta goobta la muday, qandho, calool xanuun, lallabbo, iyo shuban. Fasalka 3 ilaa 4 ee aan caadiga ahayn ee shaybaadhka ugu caansan (10%) waxay ahaayeen tiro yar oo ah lymphocytes, neutrophils, unugyada dhiiga cad, haemoglobin, iyo platelet.
Qorshaha daawaynta ee la soo jeediyay waa in la siiyo epcoritamab-bysp subcutaneously 28 maalmoodba mar ilaa uu cudurku ka sii darayo ama waxyeelada ka soo gaartaa ay aad u xun tahay. Wareegga 1, qiyaasta la soo jeediyay waa 0.16 mg maalinta 1, 0.80 mg maalinta 8, iyo 48 mg maalmaha 15 iyo 22. Tani waxay raacdaa qiyaasta go'an ee 48 mg usbuuc kasta wareegyada 2 ilaa 3, usbuuc kasta oo kale oo loogu talagalay wareegyada 4 ilaa 9, ka dibna afar toddobaad kasta oo wareeg ah maalintii.
View full prescribing information for Epkinly.
