A ranar 12-13 ga Yuni, FDA ta amince da sabbin alamomi guda biyu don maganin K, kwana ɗaya kafin a amince da maganin K don maganin kansar mahaifa. Wata rana daga baya, FDA ta Amurka ta amince da pembrolizumab (Keytruda, pembrolizumab) don kula da manya da marasa lafiya na yara tare da refractory primary mediastinal babba B-cell lymphoma (PMBCL) wanda ya sake dawowa bayan akalla layi biyu na magani.
Amincewa ya dogara ne akan bayanai daga marasa lafiya 53 tare da sake dawowa ko PMBCL mai banƙyama daga multicenter, buɗaɗɗen lakabin, gwajin hannu ɗaya KEYNOTE-170 (NCT02576990). Marasa lafiya sun karɓi 200 MG na Pembrolizumab a cikin intravenously kowane mako 3 har sai da rashin yarda da guba ko ci gaban cuta, ko har zuwa watanni 24 ga marasa lafiya waɗanda ba su ci gaba ba. Matsakaicin ƙimar tasiri gabaɗaya shine 45%, gami da 11% cikakkiyar gafara da 34% juzu'i. A lokacin lokacin biyo baya (matsakaici shine watanni 9.7), ba a kai ga lokacin mayar da martani ba. Tsakanin lokacin amsawar haƙiƙa ta farko shine watanni 2.8. Ba a ba da shawarar Pembrolizumab ga marasa lafiya tare da PMBCL waɗanda ke buƙatar rage ƙwayar ƙwayar cuta ta gaggawa ba.
A cikin KEYNOTE-170, mafi yawan halayen da ba su da kyau a cikin marasa lafiya tare da ≥10% PMBCL sune ciwon musculoskeletal, kamuwa da cuta na numfashi na sama, zazzabi, gajiya, tari, dyspnea, zawo, ciwon ciki, tashin zuciya, arrhythmia da ciwon kai. An dakatar da ko dakatar da Pembrolizumab saboda mummunan halayen a cikin 8% da 15% na marasa lafiya, bi da bi. 25% na marasa lafiya suna da mummunan halayen da ke buƙatar tsarin kulawa na corticosteroid, kuma 26% na marasa lafiya suna da mummunan halayen.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm
