Nov 2021: I-Food and Drug Administration igunyaze I-atezolizumab (Tecentriq, Genentech, Inc.) yokwelashwa kwe-adjuvant ezigulini ezinomdlavuza wamaphaphu wesigaba II ukuya ku-IIA (NSCLC) izimila zazo eziqukethe inkulumo ye-PD-L1 ngaphansi kuka-1% wamaseli wesimila, njengoba kuhlolwe ukuhlolwa okugunyazwe yi-FDA.
I-VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) nayo yagunyazwa yi-FDA namuhla njengethuluzi lokuxilonga elingumngane lokukhetha iziguli ezine-NSCLC ukuze zelashwe i-adjuvant nge-Tecentriq.
Ukusinda okungenazifo (i-DFS) kwakuyisilinganiso somphumela esibalulekile, njengoba kunqunywe umphenyi kuzibalo zokuhlaziya ukusebenza kahle (n=476) kweziguli ezinesigaba II-IIIA NSCLC nesisho se-PD-L1 ku-1% wamaseli wesimila ( PD-L1 1% TC). Engalweni ye-atezolizumab, i-DFS emaphakathi ayizange ifinyelelwe (amaphesenti angu-95 CI: 36.1, NE) uma kuqhathaniswa nezinyanga ezingu-35.3 (amaphesenti angu-95 CI: 29.0, NE) engalweni ye-BSC (HR 0.66; 95 amaphesenti CI: 0.50, 0.88; p= 0.004).
I-DFS HR yayingu-0.43 ekuhlaziyweni kweqembu elincane lesibili elishiwo ngaphambili leziguli ezine-PD-L1 TC 50% isigaba II-IIIA NSCLC (amaphesenti angu-95 CI: 0.27, 0.68). I-DFS HR yayingu-0.87 ocwaningweni lweqembu elingaphansi lokuhlola leziguli ezine-PD-L1 TC 1-49 amaphesenti esiteji II-IIIA NSCLC (amaphesenti angama-95 CI: 0.60, 1.26).
Ukwenyuka kwe-aspartate aminotransferase, i-creatinine yegazi, ne-alanine aminotransferase, kanye ne-hyperkalemia, ukuqubuka, ukukhwehlela, i-hypothyroidism, i-pyrexia, ukukhathala/i-asthenia, ubuhlungu bemisipha namathambo, i-peripheral neuropathy, i-arthralgia, kanye ne-pruritus, kwakuyizinto ezivame kakhulu (amaphesenti ayishumi) ekuphenduleni okungalungile. iziguli ezithola i-atezolizumab, okuhlanganisa nokungahambi kahle kwaselabhorethri.
Ngalesi sibonakaliso, umthamo onconywayo we-atezolizumab ngu-840 mg njalo emavikini amabili, 1200 mg njalo emavikini amathathu, noma 1680 mg njalo emavikini amane kuze kube unyaka.
