August 2021: Lorlatinib (Lorbrena, Pfizer Inc.) yakagashira mvumo yeFDA kuvarwere vane metastatic isiri-diki cell cell cancer cancer (NSCLC) vane mapundu ari anaplastic lymphoma kinase (ALK) -positive, sekutemerwa neFDA-inotenderwa bvunzo.
Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.) yakabvumidzwawo neDFA seLorlatinib shamwari yekuongorora.
Lorlatinib yakagamuchirwa kwechipiri- kana chechitatu-mutsara kurapwa kweALK-yakanaka metastatic NSCLC munaNovember 2018.
Kudzidza B7461006 (NCT03052608), yakasarudzika, multicenter, yakavhurika-chitambi, inoshanda-inodzorwa kutongwa mune 296 varwere vane ALK-positive metastatic NSCLC avo vanga vasati vamboita systemic kurapa kwe metastatic chirwere, yakashandiswa kutsigira iko ikozvino mvumo. Iyo VENTANA ALK (D5F3) CDx assay inofanirwa kuona ALK-yakanaka malignancies mune varwere. Varwere vaiwanzopihwa kuti vagamuchire chero lorlatinib 100 mg kana crizotinib 250 mg nemuromo kaviri pazuva (n = 147).
Blinded yakazvimirira central wongororo (BICR) yakawana kuti Study B7461006 yakavandudza kufambira mberi-isina kupona (PFS), ine hazard ratio ye0.28 (95 percent CI: 0.19, 0.41; p0.0001). Iyo yepakati PFS muruoko rwe lorlatinib haina kutsanangurwa, nepo yaive mwedzi 9.3 (95 muzana CI: 7.6, 11.1) muruwoko rwecrizotinib. Panguva yechidzidzo chePFS, data rese rekupona raingova muhucheche.
Kubatanidzwa kwenzvimbo yepakati yetsinga (CNS) kwakaferefetwa muvanhu vese. Kubva pamafungiro ekutanga ehuropi, varwere ve17 murorlatinib ruoko uye 13 muchombo che crizotinib vaive vaona zvisina kufanira CNS. Iko kusakosha ORR yaive 82 muzana (95 muzana CI: 57, 96) mune lorlatinib ruoko uye 23 muzana (95 muzana CI: 5, 54) mune crizotinib ruoko, sekureva kweBICR. Mune lorlatinib uye crizotinib maoko, iyo nguva yekusagadzikana kupindura yaive 12 mwedzi mu79 muzana uye 0 muzana yevarwere, zvichiteerana.
Edema, peripheral neuropathy, kuwedzera uremu, kugona kuziva, kuneta, dyspnea, arthralgia, manyoka, kushushikana kwemweya, hypercholesterolemia, hypertriglyceridemia, uye kukosora ndizvo zviitiko zvakajairika.
Lorlatinib inotorwa nemuromo kamwe chete pazuva pachiyero che100 mg.
Referensi: https://www.fda.gov/
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