Iyo US Food and Drug Administration yakabvumidza Venetoclax (Venclexta) yakasanganiswa ne rituximab (VenR) yekurapa varwere vane chronic lymphocytic leukemia (CLL) zvichibva pane diki residual chirwere (MRD) data yechikamu III MURANO kuyedza, uye kushanda kwacho kuri zviri nani zvakanyanya Mukubatana ne bendamustine uye rituximab (BR) regimen.
Chidzidzo cheMURANO chakawana kuti kushanda kwe chemoimmunotherapy kweCLL kwakabatana nemukana wekuzadzikiswa kweMRD kutendeuka, uye kana kugona kwekurapa kwezvinodhaka kuchinjisa kana kudzokorora CLL kune chekuita neMRD kutendeuka, nekuti chiyero chekushandurwa kweMRD mune varwere ava zvisingazivikanwe. pasi.
Chidzidzo cheMURANO chakaratidza kuti chirongwa cheVenR chaive nePFS iri nani yekuramba kana kudzokororwa kweCLL kana ichienzaniswa neBR regimen (HR0.17), uye MRD yeropa rekutenderera uye mwongo wepfupa wakachinja. Kushandurwa kweMRD kune yakaipa muboka reVenR kwakanga kusina hukama kana murwere ane del (17p), kwete-IGVH mutation, TP53 mutation uye zvimwe zvakashata zvinoratidzira zvinhu. Muboka reVenR, varwere ve121/194 (62%) vaiva neMRD isina kunaka pakupera kwekusanganiswa kwemishonga. Pakutevera kwepakati pemwedzi ye13.8 (mwedzi 5.6-23.0), varwere ve100 (83%) vakanga vachiri neMRD yakaipa uye 2 varwere Kufambira mberi kune PD, 2 nyaya dzakafa nechirwere chisina basa, 2 nyaya dzakafambira mberi kuRichter's syndrome, 15 kesi ( 12%) MRD yakachinja [1 kesi MRD≥10 ^ (-2) uye PD, 14 kesi MRD 10 ^ (-4) ~ <10 ^ (-2) uye 2 vavo vaiva PD, 1 akafa, uye 11 vachiri pakanga pasina kufambira mberi.
VenR kurapwa kweanodzora kana kudzokedzana CLL ine yakakwira mwero yekusagadzikana mukuwana paripheral ropa uye pfupa mwongo MRD kutendeuka, uye chimiro cheparutivi ropa reropa MRD rakabatana zvakanyanya nehukiriniki hunoshanda. VenR inogona kugonesa varwere kuti vawane yakadzika uye inogara kwenguva refu peripheral ropa MRD kutendeuka kwehuwandu padanho rekutanga, uye haina chekuita nekuti varwere vane zvakashata zvekufungidzira zvinhu, izvo zviri nani kwazvo kupfuura chirongwa cheBR. Kudzokororwa kweMRD kunoonekwa chete kune vashoma varwere uye kungangodaro kusatungamira kuchipatara chirwere chinowedzera. Zvinokurudzirwa kuti kushanda kweVenR kuri nani zvakanyanya kupfuura reg regimen yeBR, uye parizvino iri chirongwa chinokurudzirwa cheCLL inodzora kana kudzoka.
https://www.onclive.com/web-exclusives/fda-updates-venetoclax-cll-label-with-mrd-data
