Hukumar Abinci da Magunguna ta Amurka ta amince da Venetoclax (Venclexta) hade da rituximab (VenR) don kula da marasa lafiya da cutar sankarar bargo ta lymphocytic (CLL) dangane da ƙaramar cutar saura (MRD) ta lokaci na III gwajin MURANO, kuma ingancin shine mafi mahimmanci mafi kyau A hade tare da tsarin bendamustine da rituximab (BR).
Nazarin MURANO ya gano cewa ingancin chemoimmunotherapy na CLL yana da alaƙa da yiwuwar cin nasarar MRD, kuma ko ingancin maganin da aka yi niyya don ƙyamar ko sake komawa CLL yana da alaƙa da sauyawar MRD, saboda ƙimar canza MRD a cikin waɗannan marasa lafiya shine in mun gwada da ba a sani ba. low.
Binciken MURANO ya nuna cewa tsarin tsarin VenR yana da mafi kyawun PFS don refractory ko sake dawowa CLL idan aka kwatanta da tsarin BR (HR0.17), kuma MRD na jini na gefe da kasusuwa ya juya mara kyau. Juyawar MRD zuwa korau a cikin ƙungiyar VenR ba ta da alaƙa da ko mai haƙuri yana da del (17p), maye gurbi na IGVH, maye gurbi na TP53 da sauran abubuwan da ba su da kyau. A cikin ƙungiyar VenR, marasa lafiya 121/194 (62%) suna da MRD mara kyau a ƙarshen haɗin gwiwa. A cikin tsaka-tsakin watanni na 13.8 (5.6-23.0 months), marasa lafiya 100 (83%) har yanzu suna da MRD mara kyau da 2 marasa lafiya Ci gaba zuwa PD, 2 lokuta sun mutu daga cututtuka marasa mahimmanci, 2 lokuta sun ci gaba zuwa ciwo na Richter, 15 lokuta ( 12%) MRD ya juya tabbatacce [1 shari'ar MRD≥10 ^ (-2) da PD, lokuta 14 MRD 10 ^ (-4) ~ <10 ^ (-2) kuma 2 daga cikinsu PD ne, 1 ya mutu, kuma 11 har yanzu ba shi da wani ci gaba.
Maganin VenR na ƙyama ko komawa CLL yana da babban matsayi na daidaiton samun jini gefe da jijiyoyin wuya MRD, kuma matsayin jinin MRD na gefe yana da alaƙa da ingancin asibiti. VenR na iya ba marasa lafiya damar samun ƙarfin juyawar jini na MRD mai zurfi kuma mai ɗorewa a matakin farko, kuma ba shi da alaƙa da ko marasa lafiya suna da dalilai na hangen nesa, wanda ya fi shirin BR mahimmanci. Dawowar MRD ana ganin sa ne kawai cikin patientsan marasa lafiya kuma mai yiwuwa ba lallai ya haifar da ci gaban cutar asibiti ba. An ba da shawarar cewa ingancin VenR ya fi kyau fiye da tsarin BR, kuma a halin yanzu yana da tsarin da aka ba da shawara don ƙyama ko komawa CLL.
https://www.onclive.com/web-exclusives/fda-updates-venetoclax-cll-label-with-mrd-data
