Agusta 2022: Ga manya marasa lafiya masu ciwon huhu marasa ƙananan ƙwayoyin cuta (NSCLC) waɗanda ciwace-ciwacen su ke da maye gurbi wanda ya haifar da mizanin mizanin-epithelial (MET) exon 14 skipping, kamar yadda gwajin da FDA ta amince da shi, Hukumar Abinci da Magunguna ta ba capmatinib (Tabrecta). , Novartis Pharmaceuticals Corp.) amincewa na yau da kullum.
Dangane da ƙimar amsawar farko ta gabaɗaya da tsawon lokacin amsawa a cikin gwajin GEOMETRY mono-1 (NCT02414139), cibiyar sadarwa da yawa, ba bazuwar, lakabin buɗaɗɗen, bincike-binciken ƙungiyoyi masu yawa, capmatinib a baya an ba da izinin haɓaka don wannan nuni a watan Mayu. 6, 2020. Dangane da bayanai daga ƙarin marasa lafiya 63 da ƙarin watanni 22 na biyo baya don kimanta ƙarfin amsawa da kuma tabbatar da fa'idar warkewa, an yi juzu'i zuwa yarda na yau da kullun.
Marasa lafiya 160 tare da ci-gaba NSCLC tare da maye gurbin exon 14 na MET sun nuna inganci. Marasa lafiya sun karɓi capmatinib 400 MG sau biyu a rana har sai cutar ta ci gaba ko kuma tasirin sakamako ya zama mara haƙuri.
Kwamitin Bita Mai Zaman Kanta Makafi ya ƙaddara ORR da tsawon lokacin amsawa (DOR) azaman manyan matakan inganci (BIRC). Mutanen 60 waɗanda ba su taɓa karɓar magani ba suna da ORR na 68% (95% CI: 55, 80) da DOR na watanni 16.6 (95% CI: 8.4, 22.1). ORR ya kasance 44% (95% CI: 34, 54) tsakanin marasa lafiya 100 da suka karɓi magani a baya, kuma DOR shine watanni 9.7 (95% CI: 5.6, 13).
The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% White, 61% never smoked, 83% had adenocarcinoma, and 16% had metastases to the central nervous system. 81% of patients who had previously had treatment had only gotten one line of systemic therapy; 16% had received two; and 3% had received three. 86% of patients who had previously had treatment had platinum-based chemotherapy.
Marasa lafiya sun fuskanci edema, tashin zuciya, ciwon musculoskeletal, gajiya, amai, dyspnea, tari, da rage cin abinci akai-akai (20%).
Capmatinib ya kamata a sha baki sau biyu a rana a kashi na 400 MG, tare da ko ba tare da abinci ba.
Duba cikakken bayanin rubutawa na Tabrecta
