Kuvomerezedwa kwa NMPA kwa Limertinib, EGFR TKI ya m'badwo wachitatu ya chithandizo choyamba cha khansa ya m'mapapo

Pa Epulo 25, 2025, Innovent Biologics yalengeza kuti bungwe la National Medical Products Administration (NMPA) la ku China lavomereza New Drug Application (NDA) ya limertinib ngati chithandizo choyamba kwa odwala akuluakulu omwe ali ndi khansa ya m'mapapo ya non-small cell (NSCLC) yomwe ili ndi EGFR exon 19 deletions kapena exon 21 L858R mutations.

Limertinib ndi mankhwala a EGFR TKI a m'badwo wachitatu omwe amaperekedwa pakamwa, omwe ali ndi ufulu wokhala ndi mwiniwake. Yavomerezedwa ndi NMPA ya ku China kuti igwiritsidwe ntchito pa: 1) kuchiza odwala akuluakulu omwe ali ndi khansa ya m'mapapo ya EGFR T790M yomwe yasinthidwa kapena yosakhala yaying'ono (NSCLC), omwe adakumanapo ndi matendawo panthawi ya chithandizo cha EGFR TKI kapena atalandira chithandizo; ndi 2) kuchiza odwala akuluakulu omwe ali ndi NSCLC yomwe yasinthidwa kapena yosinthidwa yokhala ndi EGFR exon 19 deletions kapena exon 21 L858R mutations.

Kuvomerezedwa kwa chizindikiro chatsopanochi kumathandizidwa ndi zotsatira zabwino kuchokera ku mayeso azachipatala a Gawo 3 omwe adachitika mwachisawawa, osawona mbali zonse ziwiri, komanso olamulidwa bwino. Odwala onse 337 omwe sanalandire chithandizo omwe ali ndi EGFR-sensitive mutation-positive NSCLC m'deralo adalembetsedwa ndipo adasankhidwa mwachisawawa 1:1 kuti alandire limertinib kapena gefitinib. Mapeto ake akuluakulu anali kupulumuka popanda kupita patsogolo (PFS), monga momwe komiti yodziyimira payokha yowunikira (IRC) idanenera.

Deta inasonyeza kuti limertinib inatenga nthawi yayitali kwambiri yapakati pa PFS poyerekeza ndi gefitinib (miyezi 20.7 poyerekeza ndi miyezi 9.7), zomwe zikutanthauza kuchepetsa chiopsezo cha 56% pakukula kwa matenda kapena imfa (chiŵerengero cha zoopsa [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). Kwa odwala omwe ali ndi zilonda zapakati pa mitsempha (CNS) poyambira, CNS PFS yapakati inalinso yayitali kwambiri ndi limertinib (miyezi 20.7 poyerekeza ndi miyezi 7.1), zomwe zikugwirizana ndi kuchepetsa chiopsezo cha 72% cha kukula kwa CNS kapena imfa (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), zomwe zikusonyeza kuti imagwira ntchito mwamphamvu mkati mwa ubongo komanso imagwira ntchito bwino m'chipatala mwa anthu omwe ali ndi zosowa zambiri.

Chitetezo cha limertinib chinali chofanana ndi cha mankhwala odziwika bwino omwe amaperekedwa kwa EGFR. Zochitika zoyipa zinali zochepa mpaka zochepa ndipo zinali zovomerezeka bwino, popanda zizindikiro zatsopano zachitetezo zomwe zinapezeka panthawi yoyeserera kuchipatala. Deta yonse ndi kusanthula kuchokera ku kafukufuku wofunikira wa Gawo 3 kudzafalitsidwa m'magazini a maphunziro.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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