Musi waJune 8, US FDA yakabvumira Venetoclax (VENCLEXTA, AbbVie Inc. uye Genentech Inc.) kune varwere vane chronic lymphocytic leukemia (CLL) kana duku lymphocytic lymphoma (SLL), ine kana isina 17p deletion, zvishoma Akagamuchira kurapwa.
Kubvumidzwa kwakavakirwa paMURANO (NCT02005471), yakasarudzika (1: 1), multicenter, yakavhurika-yekuyedza muyedzo uchienzanisa rituximab ne venetoclax (VEN + R) uye bendamustine ine rituximab (B + R & lt), 389 zita CLL varwere vakagamuchirwa pa imwe chete kurapwa kwekare. VEN + R varwere vakapedza protocol. Mavhiki mashanu uye huwandu hwevhenetoclax kurapwa regimen, iko kutanga kwe rituximab, yakambotambirwa zuva nezuva 5 mg venetoclax, inokwana mwedzi makumi maviri nemana. Rituximab inoda kurapwa kwematanho matanhatu paVenetoclax (Intravenous jekiseni ye400 mg / m24 pazuva 6 rekutenderera 375, 2 mg / m1 jekiseni rekubaya mukati mezuva 1 yezvikamu 500-2, kutenderera kumwe mazuva 1). Kudzora boka. 2 kutenderera kweB + R & lt (yega yega 6 mazuva kutenderera 28 uye maviri mazuva bendamustine 6mg / m 28 uye rituximab pamusoro pemadhosi uye mashedhiyo).
Ongorora kufambira mberi-kusina kupona (PFS). Mushure mekutevera kwepakati pemwedzi ye23, PFS yepakati muVEN + R boka haina kusvika, kana ichienzaniswa nemwedzi 18.1 muboka reB + R. Nhamba yose yekupindura muboka reVEN + R yaiva 92%, nepo iyo muB + R boka yaiva 72%.
Pakati pevarwere vanorapwa neVEN + R, maitiro akajairika zvakanyanya (chiitiko ≥20%) aive neutropenia, manyoka, hutachiona hwepamusoro hwekufema, kuneta, kukosora uye kusvotwa. 64% yevarwere ava vaive negiredhi 3 kana 4 neutropenia, uye 31% vaive negiredhi 4 neutropenia. Kuita kwakakomba kwakashata kwakaitika mu46% yevarwere, hutachiona hwakakomba hwakaitika mu21% yevarwere, yakanyanya kuve chibayo (9%). Nekuda kwekukurumidza kuderera kwetsinga vhoriyamu, tumarara lysis syndrome (TLS) yakakosha njodzi kune kurapwa kweVenetoclax. Kuchengetedza kunofanira kutorwa panguva yekurapa.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610308.htm
