Ogosto 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) helay fasaxa FDA ee joogtada ah ee bukaanada qaba kansarka naasaha ee saddex geesoodka-negative (mTNBC) ee aan la dabooli karin ee gudaha ah ama metastatic kuwaas oo helay laba ama in ka badan oo daaweyn nidaam ah oo hore, ugu yaraan mid ka mid ah kaas oo loogu talagalay jirro metastatic.
Sacituzumab govitecan waxaa la siiyay oggolaansho la dardargaliyay bishii Abriil 2020 bukaannada qaba mTNBC oo markii hore lahaa ugu yaraan laba daaweyn oo loogu talagalay jirro ba'an. Maxkamadeynta xaqiijinta ansixinta degdegga ah ayaa ahayd tallaabada xigta.
Waxtarka iyo badbaadada ayaa lagu qiimeeyay 529 bukaan ah oo aan laga bogsan karin gudaha horumarsan ama mTNBC kuwaas oo dib u soo noqday ka dib ugu yaraan laba kiimiko oo hore, mid ka mid ah kaas oo ku jiri kara neoadjuvant ama adjuvant, haddii horumarku ku dhaco bilaha 12 gudahood, xarun badan, furan sumadda, tijaabada randomized (ASCENT; NCT02574455). Maalmaha 1 iyo 8 ee wareegga 21-maalin (n=267), bukaannada ayaa la kala soocay (1: 1) si ay u helaan sacituzumab govitecan, 10 mg/kg sida faleebo xididka ah, ama doorashada dhakhtarka ee kemotherabi hal wakiil ah (n= 262).
Natiijada waxtarka aasaasiga ah waxay ahayd badbaadada-horumar la'aanta (PFS) ee bukaannada aan lahayn metastases maskaxda bilawga daraasadda, sida lagu go'aamiyay indhoole, madax-bannaan, dib-u-eegis dhexe oo la adeegsanayo shuruudaha RECIST 1.1. PFS ee kooxda oo dhan (oo leh iyo aan lahayn metastases maskaxda) iyo guud ahaan badbaadada ayaa sidoo kale lagu daray ujeedooyinka waxtarka (OS).
Bukaanada qaata sacituzumab govitecan waxay haysteen PFS dhexdhexaad ah oo ah 4.8 bilood (95 boqolkiiba inta u dhaxaysa kalsoonida: 4.1, 5.8) marka la barbar dhigo 1.7 bilood (95 boqolkiiba inta u dhaxaysa kalsoonida: 1.5, 2.5) kuwa qaata kiimoteraabiga (HR 0.43; 95 boqolkiiba dhexgalka kalsoonida: 0.35, 0.54; p0.0001). Dhexdhexaadiyaha OS wuxuu ahaa 11.8 bilood (95 boqolkiiba dhexgalka kalsoonida: 10.5, 13.8) ragga iyo 6.9 bilood (95 boqolkiiba dhexgalka kalsoonida: 5.9, 7.6) dumarka (HR 0.51; 95 boqolkiiba dhexgalka kalsoonida: 0.41, 0.62; p0.0001) .
Lalabbo, neutropenia, shuban, dawakhaad, alopecia, dhiig -yaraan, matag, calool -fadhi, finan, rabitaanka cuntada oo yaraada, iyo raaxo -darrada caloosha ayaa ah dhacdooyinka dhinaca ugu badan (dhacdada> 25%) ee bukaannada qaadanaya sacituzumab govitecan.
Ilaa horumarka cudurka ama sumowga aan loo dulqaadan karin, qiyaasta lagu taliyey sacituzumab govitecan waa 10 mg/kg hal mar toddobaadkii maalmaha 1 iyo 8 ee wareegyada daaweynta 21-maalmood ah.
Tixraac: https://www.fda.gov/
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