I-Osimertinib ene-chemotherapy igunyazwe yi-USFDA ye-EGFR-mutated non-small cell lung cancer.

I-Food and Drug Administration igunyaze i-osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) ngokuhlanganiswa ne-chemotherapy esekelwe ku-platinum yeziguli ezinomdlavuza wamaphaphu osezingeni eliphezulu noma we-metastatic non-small cell wamaphaphu (la/mNSCLC) abanezimila ezinokususwa kwe-EGFR exon 19 noma ukuguqulwa kwe-exon 21 L858R, njengoba kukhonjwe ukuhlolwa okugunyazwe yi-FDA, ngoFebhuwari. 16, 2024.

Ukuhlolwa kwenziwa ku-FLAURA 2 (NCT04035486), ucwaningo olungahleliwe, olunelebula evulekile nabantu abangu-557 abaye basuswa i-EGFR exon 19 noma i-exon 21 L858R eguquguqukayo ethuthuke kakhulu endaweni noma umdlavuza wamaphaphu we-metastatic non-small cell lung (NSCLC) futhi waba nomdlavuza wamaphaphu. wayengakaze abe nokwelashwa okuhlelekile kokugula okuthuthukile ngaphambili. Iziguli zabelwa ngokungahleliwe ngesilinganiso esingu-1:1 ukuze zithole i-osimertinib kanye ne-platinum-based chemotherapy noma i-osimertinib iyodwa.

Isilinganiso esiyinhloko sokusebenza bekungukusinda kwe-progression-free (PFS), esihlolwe umphenyi, nokusinda kukonke (i-OS) njengesinyathelo sesibili esibalulekile. Lapho i-osimertinib ihlanganiswa ne-chemotherapy-based chemotherapy, i-progression-free survival (PFS) yayiphezulu kakhulu kunangesikhathi i-osimertinib isetshenziswa iyodwa. Isilinganiso sengozi sasingu-0.62 (95% CI: 0.49–0.79; inani le-p elinezinhlangothi ezimbili <0.0001). Ukusinda kwe-median progression-free survival (PFS) kwakuyizinyanga ezingu-25.5 nge-95% isikhawu sokuzethemba (CI) se-24.7 ukuze singenakulinganiswa (NE) engalweni eyodwa, kanye nezinyanga ezingu-16.7 nge-95% CI ye-14.1 kuya ku-21.3 kwenye ingalo.

Nakuba zizonke izibalo zokusinda azizange zithuthukiswe ngokugcwele ekuhlaziyweni kwamanje, ngama-45% nje kuphela abantu abashonile abashiwo ngaphambili ababikwe ukuze kuhlaziywe okokugcina, kwakungekho nkomba yokuthambekela okungekuhle.

I-Leukopenia, i-thrombocytopenia, i-neutropenia, i-lymphopenia, ukuqubuka, isifo sohudo, i-stomatitis, ukulimala kwezinzipho, isikhumba esomile, kanye namazinga aphezulu e-creatinine egazini kwakungeminye yemiphumela emibi kakhulu eyenzeka kubantu abanikezwa i-osimertinib kanye ne-chemotherapy esekelwe ku-platinum.

Umthamo ophakanyisiwe we-osimertinib ngu-80 mg othathwa ngomlomo kanye ngosuku, ngokudla noma ngaphandle kokudla, kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki. Xhumana nolwazi oluchazayo lwe-pemetrexed ne-cisplatin noma i-carboplatin ukuze uthole imininingwane ethile yomthamo.