Maamulka Cuntada iyo Dawooyinka ee Maraykanka ayaa ansixiyay Venetoclax (Venclexta) oo ay weheliso rituximab (VenR) ee loogu talagalay daaweynta bukaannada qaba leukemia lymphocytic chronic (CLL) oo ku salaysan xogta cudurka haraaga ugu yar (MRD) ee wajiga III MURANO, waxtarkeeduna waa si aad ah uga wanaagsan Marka lagu daro nidaamka bendamustine iyo rituximab (BR).
Daraasadda MURANO waxay ogaatay in waxtarka daaweynta kiimikada ee loogu talagalay CLL ay la xiriirto suurtagalnimada in la gaaro beddelaadda MRD, iyo in waxtarka daaweynta daroogada la beegsaday ee diidmada ama soo noqoshada CLL ay la xiriirto beddelaadda MRD, sababtoo ah heerka beddelaadda MRD ee bukaanadan waa aan la aqoon. hooseeya.
The MURANO study showed that VenR regimen had better PFS for refractory or relapsed CLL compared with BR regimen (HR0.17), and the MRD of peripheral blood and bone marrow turned negative. The conversion of MRD to negative in the VenR group was not related to whether the patient had del (17p), non-IGVH mutation, TP53 mutation and other adverse prognostic factors. In the VenR group, 121/194 patients (62%) had MRD negative at the end of the combination therapy. At a median follow-up of 13.8 months (5.6-23.0 months), 100 patients (83%) still had negative MRD and 2 patients Progression to PD, 2 cases died of irrelevant disease, 2 cases progressed to Richter’s syndrome, 15 cases (12%) MRD turned positive [1 case MRD≥10 ^ (-2) and PD, 14 cases MRD 10 ^ (-4) ~ <10 ^ (-2) and 2 of them were PD, 1 died, and 11 still had no progress.
Daaweynta 'VenR' ee diidmada ama soo noqoshada CLL waxay leedahay heer sare oo joogto ah helitaanka dhiigga durugsan iyo dhuuxa dhuuxa MRD, iyo xaaladda dhiigga durugsan ee MRD waxay si weyn ula xiriirtaa waxtarka caafimaad. VenR waxay bukaanka u suurtagelin kartaa inay helaan qaddar dheer oo waara dhiigga durugsan ee MRD heerka u-beddelashada marxaladda hore, waxbana kuma laha haddii bukaanku leeyahay arrimo qibrad u leh saadaalinta, taas oo si weyn uga wanaagsan barnaamijka BR. Dib u soo noqoshada MRD waxaa lagu arkaa bukaano kooban oo lagama yaabo inay horseed u noqoto horumarka cudurka. Waxaa la soo jeedinayaa in waxtarka VenR uu si weyn uga fiicanyahay nidaamka BR, hadana waa nidaam lagula taliyay diidmada ama soo noqoshada CLL.
https://www.onclive.com/web-exclusives/fda-updates-venetoclax-cll-label-with-mrd-data