Agasti 2021: I-Lorlatinib (Lorbrena, Pfizer Inc.) ithole imvume ye-FDA evamile yeziguli ezinomdlavuza wamaphaphu we-metastatic non-small cell lung (NSCLC) izimila zazo ziyi-anaplastic lymphoma kinase (ALK) -positive, njengoba kunqunywe ukuhlolwa okugunyazwe yi-FDA.
IVentana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.) nayo igunyazwe yi-FDA njenge-diagnostic ye-lorlatinib.
ILorlatinib yamukelwa ukwelashwa komugqa wesibili noma wesithathu kwe-ALK-positive metastatic NSCLC ngoNovemba 2018.
I-Study B7461006 (NCT03052608), i-randomized, multicenter, ilebula evulekile, isilingo esilawulwa ngokusebenzayo ezigulini ezingama-296 ezine-ALK-positive metastatic NSCLC ezazingakaze zithole ukwelashwa kwangaphambili kohlelo lokugula kwe-metastatic, kwasetshenziswa ukuxhasa imvume yamanje. Isivivinyo se-VENTANA ALK (D5F3) CDx kufanele sithole ukungalungi okuhle kwe-ALK ezigulini. Iziguli zabelwa ngezikhathi ezithile ukuthola i-lorlatinib 100 mg noma i-crizotinib 250 mg ngomlomo kabili ngosuku (n = 147).
Ukubuyekeza okumaphakathi okuzimele okungabonisiwe (BICR) kuthole ukuthi i-Study B7461006 ithuthukise ukusinda kwe-progression-free survival (PFS), ngesilinganiso sengozi esingu-0.28 (95 amaphesenti CI: 0.19, 0.41; p0.0001). I-PFS ephakathi engalweni ye-lorlatinib ayizange inqunywe, kuyilapho kwakuyizinyanga ezingu-9.3 (amaphesenti angu-95 CI: 7.6, 11.1) engalweni ye-crizotinib. Ngesikhathi socwaningo lwe-PFS, idatha yokusinda iyonke yayisencane.
Ukubandakanywa kwesistimu yezinzwa emaphakathi (CNS) kwaphenywa kubo bonke abantu. Ngokususelwa ekucabangeni kobuchopho okuyisisekelo, iziguli ze-17 engalweni ye-lorlatinib kanye ne-13 engalweni ye-crizotinib zazinokungaqondakali okubonakalayo kwe-CNS. I-ORR engasebenzi yayingamaphesenti angama-82 (95% CI: 57, 96) engalweni ye-lorlatinib namaphesenti angama-23 (95% CI: 5, 54) engalweni ye-crizotinib, ngokwe-BICR. Ezingalweni ze-lorlatinib ne-crizotinib, isikhathi sokuphendula okungahambisani nokusebenza kahle kwakuyizinyanga eziyi-12 ngamaphesenti angama-79 namaphesenti ama-0 eziguli, ngokulandelana.
I-Edema, i-peripheral neuropathy, ukukhuluphala kwesisindo, imiphumela yokuqonda, ukukhathala, i-dyspnea, i-arthralgia, isifo sohudo, imiphumela ye-mood, i-hypercholesterolemia, i-hypertriglyceridemia, nokukhwehlela kube yimicimbi eseceleni edlange kakhulu (izehlakalo ezingama-20%), obekubandakanya ukungajwayelekile kwelebhu yebanga lesi-3-4.
I-Lorlatinib ithathwa ngomlomo kanye ngosuku ngomthamo we-100 mg.
Inkomba: https://www.fda.gov/
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