Musi wa25 Kubvumbi, 2025, Innovent Biologics yakazivisa kuti National Medical Products Administration (NMPA) yeChina yakabvumidza New Drug Application (NDA) ye limertinib senzira yekutanga yekurapa varwere vakuru vane kenza yemapapu isina masero madiki (NSCLC) ine EGFR exon 19 deletions kana exon 21 L858R mutations.
Limertinib mushonga wechizvarwa chechitatu weEGFR TKI unopihwa nemuromo une kodzero dzekuva muridzi. Wakatenderwa neNMPA yeChina kuti ushande pa: 1) kurapa varwere vakuru vane kenza yemapapu yeEGFR T790M yakachinja masero madiki (NSCLC) iri munharaunda kana kuti yakapararira, avo vakambosangana nechirwere ichi panguva yekurapwa neEGFR TKI kana mushure mekurapwa; uye 2) kurapa kwekutanga kwevarwere vakuru vane NSCLC yakapararira kana yakapararira yakatakura EGFR exon 19 deletions kana exon 21 L858R mutations.
Kubvumidzwa kwechiratidzo chitsva ichi kunotsigirwa nemigumisiro yakanaka kubva mukuyedzwa kwekiriniki kwechikamu chechitatu chisina kujeka, chakapofumadzwa kaviri, uye chakadzorwa zvakanaka. Varwere vanosvika 337 vasina kurapwa vane EGFR-sensitive mutation-positive munharaunda yepamusoro kana metastatic NSCLC vakanyoreswa uye vakasarudzirwa 1:1 kuti vagamuchire limertinib kana gefitinib. Mugumo mukuru waive wekurarama pasina progression-free survival (PFS), sezvakaongororwa nekomiti yakazvimirira yekuongorora (IRC).
Data rakaratidza kuti limertinib yakawedzera zvakanyanya pakati pePFS zvichienzaniswa negefitinib (mwedzi 20.7 vs. mwedzi 9.7), zvichireva kudzikira kwengozi ye56% mukufambira mberi kwechirwere kana kufa (hazard ratio [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). Muvarwere vane kukuvara kwepakati petsinga (CNS) pakutanga, pakati peCNS PFS yaive yakarebawo zvakanyanya nelimertinib (mwedzi 20.7 vs. mwedzi 7.1), zvichienderana nekudzikira kwengozi ye72% yekufambira mberi kweCNS kana kufa (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), zvichiratidza kushanda kwayo kwakasimba mukati memusoro uye kushanda kwayo mukiriniki muvanhu vakadaro vane zvinodiwa zvisina kuzara.
Kuchengetedzwa kwe limertinib kwaienderana nekwemishonga inozivikanwa yakanangana neEGFR. Zviitiko zvakaipa zvaive zvishoma kusvika pakati nepakati uye zvaishivirirwa zvakanaka, pasina zviratidzo zvitsva zvekuchengetedza zvakaonekwa panguva yekuedzwa kwekiriniki. Ruzivo rwakazara uye ongororo kubva muchidzidzo ichi chakakosha chePase 3 zvichaburitswa mumajenari edzidzo.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Nguva yekutumira: Chivabvu-07-2025