A ranar 8 ga Yuni, FDA ta Amurka ta amince da Venetoclax (VENCLEXTA, AbbVie Inc. da Genentech Inc.) ga marasa lafiya da cutar sankarar lymphocytic na kullum (CLL) ko ƙananan lymphoma lymphocytic (SLL), tare da ko ba tare da 17p sharewa ba, aƙalla An karɓi magani.
Amincewa ya dogara ne akan MURANO (NCT02005471), bazuwar (1: 1), multicenter, bude-lakabin gwaji kwatanta rituximab tare da venetoclax (VEN + R) da bendamustine tare da rituximab (B + R & lt), 389 suna marasa lafiya CLL da aka karɓa a akalla magani daya da ya gabata. Marasa lafiya na VEN + R sun kammala yarjejeniya. Makonni 5 da adadin tsarin maganin venetoclax, sannan farawar rituximab, sau ɗaya ana karɓar kowace rana 400 mg mg venetoclax, jimlar watanni 24. Rituximab yana buƙatar kulawa don zagaye na 6 akan Venetoclax (Inura mai ƙwanƙwasawa na 375 mg / m2 a ranar 1 na zagayowar 1, 500 mg / m2 na allurar rigakafi a ranar 1 na hawan keke 2-6, zagaye ɗaya kwana 28). Controlungiyar kulawa. 6 zagaye na B + R & lt (kowace zagayowar rana ta 28 1 da 2 kwana bendamustine 70mg / m 2 da rituximab sama da allurai da jadawalai).
Tantance rayuwa marar ci gaba (PFS). Bayan bin tsaka-tsaki na watanni 23, PFS na tsakiya a cikin ƙungiyar VEN + R ba a kai ba, idan aka kwatanta da watanni 18.1 a cikin ƙungiyar B + R. Jimlar yawan amsawa a cikin rukunin VEN + R shine 92%, yayin da na B + R ya kasance 72%.
Daga cikin marasa lafiyar da aka yi wa magani tare da VEN + R, mafi munin halayen rashin lafiya (abin da ya faru ≥20%) sun hada da neutropenia, gudawa, kamuwa da cututtukan fili na sama, gajiya, tari da tashin zuciya 64% na waɗannan marasa lafiya suna da aji 3 ko 4, kuma 31% suna da aji 4 na neutropenia. M mummunan halayen ya faru a cikin 46% na marasa lafiya, cututtuka masu tsanani sun faru a cikin 21% na marasa lafiya, mafi mahimmanci shine ciwon huhu (9%). Saboda saurin raguwa a cikin ƙwayar tumo, cututtukan ƙwayar cuta na ƙwayar cuta (TLS) shine mahimmin haɗarin haɗari don maganin Venetoclax. Yakamata a kula yayin magani.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610308.htm
