Fabrairu 2023: An ba da izini ga gaggawa ta FDA ga pirtobrutinib (Jaypirca, Eli Lilly da Kamfani) don sake dawowa ko ƙwayar ƙwayar ƙwayar cuta.
A cikin BRUIN (NCT03740529), alamar budewa, multicenter, gwaji guda ɗaya na pirtobrutinib monotherapy wanda ya ƙunshi marasa lafiya na 120 MCL waɗanda suka karbi maganin hanawa na BTK a baya, an kimanta tasiri. Marasa lafiya sun karɓi tsaka-tsaki na layin jiyya guda uku a baya, tare da 93% suna karɓar biyu ko fiye. Ibrutinib (67%), acalabrutinib (30%), da zanubrutinib (8%), waɗanda aka fi yawan wajabta kafin masu hana BTK, an dakatar da su ta 83% na marasa lafiya saboda rashin ƙarfi ko muni. An ba Pirtobrutinib a baki sau ɗaya a rana a kashi na 200 MG kuma ya ci gaba har sai cutar ta ci gaba ko kuma sakamakon ya zama mai wuya.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR), kamar yadda kwamitin bita mai zaman kansa ya ƙaddara ta amfani da ma'aunin Lugano, sune matakan ingantaccen aiki na farko. ORR ya kasance 50% (95% CI: 41, 59) kuma 13% na masu amsa sun kammala binciken gaba ɗaya. An kiyasta ƙimar DOR a watanni 6 zuwa 65.3% (95% CI: 49.8, 77.1), kuma matsakaicin matsakaicin DOR shine watanni 8.3 (95% CI: 5.7, NE).
A cikin marasa lafiya da MCL, gajiya, rashin jin daɗi na musculoskeletal, zawo, edoema, dyspnea, ciwon huhu, da ƙumburi sune mafi yawan sakamako masu illa (15%). Ragewar neutrophil, lymphocyte, da platelet ƙidaya sun kasance aji na 3 ko 4 na rashin daidaituwa a cikin 10% na mutane. Kariya da faɗakarwa game da cututtuka, zub da jini, cytopenia, fibrillation atrial da flutter, da kuma na biyu manyan malignancies an haɗa su a cikin kayan rubutun.
Ana ba da shawarar shan 200 MG na pirtobrutinib sau ɗaya kowace rana har sai cutar ta ci gaba ko kuma mai guba ya zama wanda ba zai iya jurewa ba.
