Ukuvunywa kwe-NMPA kwe-Limertinib, i-EGFR TKI yesizukulwana sesithathu yoNyango loMhlaza weMiphunga

Ngomhla wama-25 ku-Epreli, ngo-2025, i-Innovent Biologics ibhengeze ukuba i-National Medical Products Administration (NMPA) yaseTshayina ivumile iSicelo seMithi emitsha (NDA) se-limertinib njengonyango lokuqala kwizigulane zabantu abadala abanomhlaza wemiphunga ongengoweseli encinci (NSCLC) oqhubekekayo okanye osasazekileyo obangela i-EGFR exon 19 deletions okanye i-exon 21 L858R mutations.

I-Limertinib yi-EGFR TKI yesizukulwana sesithathu elawulwa ngomlomo, enamalungelo obunikazi. Ivunyiwe yi-NMPA yaseTshayina ngenxa yezi zinto zilandelayo: 1) unyango lwezigulane zabantu abadala abane-EGFR T790M-mutated non-small cell lung cancer (NSCLC) eguqulweyo okanye eguqulweyo, abakhe bahlangabezana nokukhula kwesifo ngexesha okanye emva konyango nge-EGFR TKI; kunye 2) unyango lokuqala lwezigulane zabantu abadala abane-NSCLC ephuculweyo okanye eguqulweyo ephethe i-EGFR exon 19 deletions okanye i-exon 21 L858R mutations.

Ukuvunywa kwesi sibonakaliso sitsha kuxhaswa ziziphumo ezilungileyo ezivela kuvavanyo lweklinikhi lweSigaba sesi-3 olucwangcisiweyo ngokungacwangciswanga, olungaboni kabini, nolulawulwa kakuhle. Izigulane ezingama-337 ezingenalo unyango ezine-EGFR-sensitive mutation-positive local advanced okanye metastatic NSCLC zabhaliswa kwaye zacwangciswa ngokungacwangciswanga 1:1 ukuze zifumane i-limertinib okanye i-gefitinib. Isiphelo esiphambili yayikukusinda okungenankqubela phambili (PFS), njengoko kuqinisekiswe yikomiti yophononongo ezimeleyo (IRC).

Idatha ibonise ukuba i-limertinib yandisa kakhulu i-median PFS xa ithelekiswa ne-gefitinib (iinyanga ezingama-20.7 xa kuthelekiswa neenyanga ezili-9.7), nto leyo ebonisa ukuncipha komngcipheko we-56% ekuqhubekeni kwesifo okanye ekufeni (umlinganiselo wobungozi [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). Kwizigulane ezinezilonda ze-central nervous system (CNS) ekuqaleni, i-median CNS PFS nayo yayinde kakhulu nge-limertinib (iinyanga ezingama-20.7 xa kuthelekiswa neenyanga ezili-7.1), okuhambelana nokunciphisa umngcipheko we-72% ekuqhubekeni okanye ekufeni kwe-CNS (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), nto leyo egxininisa umsebenzi wayo oqinileyo ngaphakathi kwentloko kunye nenzuzo yeklinikhi kubantu abanjalo abaneemfuno ezingafikelelwanga.

Iprofayili yokhuseleko lwe-limertinib yayihambelana neyezonyango ezaziwa ngokuba yi-EGFR. Iziganeko ezimbi zazincinci ukuya kwephakathi kwaye zazinyamezelwa kakuhle, kungekho zimpawu zintsha zokhuseleko ezichongiweyo ngexesha lovavanyo lweklinikhi. Idatha epheleleyo kunye nohlalutyo oluvela kolu phononongo lubalulekileyo lweSigaba sesi-3 luya kupapashwa kwiijenali zemfundo.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

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