Agusta 2021: Lorlatinib (Lorbrena, Pfizer Inc.) ya sami amincewar FDA na yau da kullum ga marasa lafiya tare da ciwon daji marasa ƙananan ƙwayoyin cuta (NSCLC) waɗanda ciwace-ciwacen su ne anaplastic lymphoma kinase (ALK) -tabbatacce, kamar yadda jarrabawar FDA ta amince.
Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.) kuma FDA ta ba da izini a matsayin abokin binciken lolatinib.
An amince da Lorlatinib don jiyya na layi na biyu ko na uku na ALK-tabbatacce metastatic NSCLC a cikin Nuwamba 2018.
Nazarin B7461006 (NCT03052608), bazuwar, multicenter, alamar buɗewa, gwaji mai sarrafa aiki a cikin marasa lafiya 296 tare da ALK-tabbatacce metastatic NSCLC waɗanda ba su da tsarin jiyya na farko don rashin lafiya na metastatic, an yi amfani da su don tallafawa amincewar yanzu. VENTANA ALK (D5F3) CDx assay dole ne ya gano ALK-tabbataccen malignancies a cikin marasa lafiya. An ba marasa lafiya ba da izini don karɓar ko dai lolatinib 100 mg ko crizotinib 250 mg na baki sau biyu a rana (n=147).
Blinded independent central review (BICR) found that Study B7461006 improved progression-free survival (PFS), with a hazard ratio of 0.28 (95 percent CI: 0.19, 0.41; p0.0001). The median PFS in the lorlatinib arm was not determined, while it was 9.3 months (95 percent CI: 7.6, 11.1) in the crizotinib arm. At the time of the PFS study, the overall survival data was only in its infancy.
An bincika shigar da tsarin kulawa na tsakiya (CNS) a cikin duk mutane. Dangane da hoton kwakwalwa na asali, marasa lafiya 17 a cikin hannun lolatinib da 13 a cikin hannun crizotinib suna da alamun rashin daidaituwa na CNS. ORR na intracranial shine kashi 82 cikin dari (95 bisa dari CI: 57, 96) a cikin hannun lolatinib da kashi 23 (95 bisa dari CI: 5, 54) a cikin hannun crizotinib, bisa ga BICR. A cikin lolatinib da crizotinib makamai, tsawon lokacin amsawar intracranial shine watanni 12 a cikin kashi 79 da 0 bisa dari na marasa lafiya, bi da bi.
Edema, na gefe neuropathy, riba mai nauyi, fahimi tasirin, gajiya, dyspnea, arthralgia, gudawa, yanayi effects, hypercholesterolemia, hypertriglyceridemia, da tari sun kasance mafi m al'amurran da suka shafi gefe (lamuni 20%), wanda ya hada da Grade 3-4 dakin gwaje-gwaje nakasu.
Lorlatinib ana shan baki sau ɗaya a rana a kashi na 100 MG.
Magana: https://www.fda.gov/
Don Allah a karanta nan.
