Ukuvunyelwa kwe-NMPA kwe-Limertinib, i-EGFR TKI yesizukulwane sesithathu yokwelashwa komdlavuza wamaphaphu komugqa wokuqala

Ngo-Ephreli 25, 2025, i-Innovent Biologics imemezela ukuthi i-National Medical Products Administration (NMPA) yaseShayina ivumile i-New Drug Application (NDA) ye-limertinib njengokwelashwa kokuqala kweziguli ezindala ezinomdlavuza wamaphaphu ongeyona encane (NSCLC) othuthukisiwe endaweni noma osakazeke endaweni ethile one-EGFR exon 19 deletions noma i-exon 21 L858R mutations.

I-Limertinib iyi-EGFR TKI yesizukulwane sesithathu enikezwa ngomlomo, enamalungelo obunikazi. Ivunyiwe yi-NMPA yaseShayina ukuze ithole okulandelayo: 1) ukwelashwa kweziguli ezindala ezine-EGFR T790M-mutated non-small cell lung cancer (NSCLC) ethuthukisiwe noma eguquliwe endaweni ethile, ezike zabhekana nokuqhubeka kwesifo ngesikhathi noma ngemva kokwelashwa nge-EGFR TKI; kanye 2) ukwelashwa kokuqala kweziguli ezindala ezine-NSCLC ethuthukisiwe noma eguquliwe endaweni ethile noma eguquliwe e-EGFR exon 19 noma i-exon 21 L858R mutations.

Ukuvunyelwa kwalesi sibonakaliso esisha kusekelwa yimiphumela emihle evela esivivinyweni somtholampilo seSigaba sesi-3 esingahleliwe, esingaboni kabili, esilawulwa kahle. Iziguli ezingu-337 ezingalashwanga ezine-EGFR-sensitive mutation-positive localized advanced noma metastatic NSCLC zabhaliswa futhi zahlelwa ngo-1:1 ukuze zithole i-limertinib noma i-gefitinib. Isiphetho esiyinhloko kwakuwukusinda okungenazo i-progression-free (PFS), njengoba kuqinisekiswe yikomidi elizimele lokubuyekeza (IRC).

Idatha ikhombisile ukuthi i-limertinib yandisa kakhulu i-PFS ephakathi uma iqhathaniswa ne-gefitinib (izinyanga ezingu-20.7 uma kuqhathaniswa nezinyanga ezingu-9.7), okumele ukwehla kwengozi okungu-56% ekuqhubekeni kwesifo noma ekufeni (isilinganiso sengozi [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). Ezigulini ezinezilonda zesistimu yezinzwa ephakathi (CNS) ekuqaleni, i-PFS ephakathi nayo yayinde kakhulu nge-limertinib (izinyanga ezingu-20.7 uma kuqhathaniswa nezinyanga ezingu-7.1), okuhambisana nokwehla kwengozi okungu-72% kokuqhubekela phambili noma ukufa kwe-CNS (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), okugcizelela umsebenzi wayo oqinile wangaphakathi kwekhanda kanye nokusetshenziswa kwemitholampilo kubantu abanjalo abanezidingo ezingakahlangatshezwa.

Iphrofayili yokuphepha ye-limertinib yayihambisana neyezindlela zokwelapha ezaziwa nge-EGFR. Izehlakalo ezimbi zazivame ukuba zincane kuya kweziphakathi futhi zazibekezelelwa kahle, kungekho zimpawu ezintsha zokuphepha ezitholakale ngesikhathi sokuhlolwa kwezokwelapha. Idatha ephelele kanye nokuhlaziywa okuvela kulolu cwaningo olubalulekile lweSigaba sesi-3 kuzoshicilelwa emaphephandabeni ezemfundo.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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