Thaum Lub Plaub Hlis 25, 2025, Innovent Biologics tshaj tawm tias Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo Daim Ntawv Thov Tshuaj Tshiab (NDA) rau limertinib ua thawj kab kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav hauv lub ntsws uas tsis yog me me (NSCLC) uas muaj EGFR exon 19 deletions lossis exon 21 L858R mutations.
Limertinib yog ib hom tshuaj EGFR TKI tiam peb uas muab los ntawm qhov ncauj thiab muaj cai tshwj xeeb. Nws tau txais kev pom zoo los ntawm Tuam Tshoj NMPA rau: 1) kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav EGFR T790M-mutated non-small cell lung cancer (NSCLC) uas tau kis mus rau lwm qhov chaw hauv zos, uas tau muaj mob hnyav zuj zus thaum lossis tom qab kev kho mob nrog EGFR TKI; thiab 2) kev kho mob thawj kab rau cov neeg laus uas muaj mob qog nqaij hlav NSCLC uas tau kis mus rau lwm qhov chaw hauv zos thiab muaj EGFR exon 19 deletions lossis exon 21 L858R mutations.
Kev pom zoo rau qhov cim tshiab no tau txais kev txhawb nqa los ntawm cov txiaj ntsig zoo los ntawm kev sim tshuaj theem 3 uas tsis pom tseeb, ob leeg dig muag, thiab tswj tau zoo. Tag nrho ntawm 337 tus neeg mob uas tsis tau kho mob uas muaj EGFR-sensitive mutation-positive locally advanced lossis metastatic NSCLC tau raug sau npe thiab xaiv 1: 1 kom tau txais limertinib lossis gefitinib. Lub hom phiaj tseem ceeb yog kev ciaj sia nyob tsis muaj kev nce qib (PFS), raws li pawg neeg saib xyuas kev ywj pheej (IRC) tau ntsuas.
Cov ntaub ntawv qhia tau tias limertinib ntev dua qhov nruab nrab ntawm PFS piv rau gefitinib (20.7 lub hlis vs. 9.7 lub hlis), uas sawv cev rau 56% kev txo qis kev pheej hmoo ntawm kev mob hnyav lossis kev tuag (kev pheej hmoo piv [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). Hauv cov neeg mob uas muaj cov kab mob hauv lub paj hlwb (CNS) thaum pib, qhov nruab nrab ntawm CNS PFS kuj ntev dua nrog limertinib (20.7 lub hlis vs. 7.1 lub hlis), uas sib raug rau 72% kev txo qis kev pheej hmoo rau kev mob hnyav lossis kev tuag ntawm CNS (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), qhia txog nws cov haujlwm intracranial muaj zog thiab kev siv tau zoo hauv cov pej xeem uas muaj kev xav tau ntau.
Cov ntaub ntawv kev nyab xeeb ntawm limertinib zoo ib yam li cov kev kho mob uas paub txog EGFR. Cov teeb meem tsis zoo feem ntau tsis hnyav heev mus rau nruab nrab thiab zam tau zoo, tsis muaj cov cim qhia kev nyab xeeb tshiab pom thaum lub sijhawm sim tshuaj. Cov ntaub ntawv tag nrho thiab kev tshuaj xyuas los ntawm kev tshawb fawb theem 3 tseem ceeb no yuav raug luam tawm hauv cov ntawv xov xwm kev kawm.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Tsib Hlis-07-2025