August 2021: Lorlatinib (Lorbrena, Pfizer Inc.) waxay heshay oggolaanshaha joogtada ah ee FDA ee bukaannada qaba kansarka sanbabada unugyada unugyada yaryar (NSCLC) kuwaas oo burooyinkooda ay yihiin anaplastic lymphoma kinase (ALK) -positive, sida lagu go'aamiyay baaritaanka FDA-la ansixiyay.
Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.) ayaa sidoo kale FDA u oggolaatay inay tahay ogaanshaha wehelka lorlatinib.
Lorlatinib waxaa loo oggolaaday daweynta labaad ama saddexaad ee ALK-positive metastatic NSCLC bishii Nofembar 2018.
Daraasadda B7461006 (NCT03052608), kala-soocid, kala-duwan, calaamad furan, tijaabo firfircoon oo kontorool ku leh 296 bukaan oo leh ALK-positive metastatic NSCLC oo aan hore u haysan daaweyn nidaamsan oo loogu talagalay jirro ba'an, ayaa loo isticmaalay in lagu taageero oggolaanshaha hadda. VENTANA ALK (D5F3) Tijaabada CDx waa inay ogaataa cudurrada ALK-togan ee bukaannada. Bukaan -socodka ayaa si aan kala sooc lahayn loogu qoondeeyay inay helaan lorlatinib 100 mg ama crizotinib 250 mg afka laba jeer maalintii (n = 147).
Dib-u-eegis dhexe oo madax-bannaan oo indho la'aan ah (BICR) waxay ogaatay in Daraasadda B7461006 ay hagaajisay badbaadada horumarka-la'aanta ah (PFS), oo leh saamiga khatarta ah 0.28 (95 boqolkiiba CI: 0.19, 0.41; p0.0001). Dhexdhexaadiyaha PFS ee cududda lorlatinib lama go'aamin, halka ay ahayd 9.3 bilood (95 boqolkiiba CI: 7.6, 11.1) ee cududda crizotinib. Waqtigii daraasadda PFS, xogta guud ee badbaadada waxay ahayd bilawga kaliya.
Ku lug lahaanshaha nidaamka dhexe ee neerfayaasha (CNS) ayaa lagu baaray dhammaan shaqsiyaadka. Iyada oo ku saleysan sawirka aasaasiga ah ee maskaxda, 17 bukaan oo ku jira gacanta lorlatinib iyo 13 oo ku jira gacanta crizotinib waxay lahaayeen cillado aan la garan karin oo CNS ah. ORR -ka gudaha ayaa ahaa 82 boqolkiiba (95 boqolkiiba CI: 57, 96) ee gacanta lorlatinib iyo 23 boqolkiiba (95 boqolkiiba CI: 5, 54) ee gacanta crizotinib, sida uu qabo BICR. Gacmaha lorlatinib iyo crizotinib, muddada jawaab -celinta intracranial waxay ahayd 12 bilood 79 boqolkiiba iyo 0 boqolkiiba bukaannada, siday u kala horreeyaan.
Edema, neeropathy peripheral, korodhka miisaanka, saamaynta garashada, daal, dyspnea, arthralgia, shuban, saamaynta niyadda, hypercholesterolemia, hypertriglyceridemia, iyo qufac ayaa ah dhacdooyinka dhinaca ugu baahsan (dhacdada 20%), oo ay ku jiraan cilladaha shaybaarka Fasalka 3-4.
Lorlatinib waxaa afka laga qaataa hal mar maalintii qiyaasta 100 mg.
Tixraac: https://www.fda.gov/
Fadlan akhri halkan.
