Pa Januwale 16, 2025, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza kugwiritsa ntchito mankhwala atsopano a limertinib (NDA) pochiza odwala akuluakulu omwe ali ndi khansa ya m'mapapo ya EGFR T790M yomwe si yaing'ono (NSCLC) yomwe yakula kwambiri kapena yofalikira m'derali.
About Limertinib
Limertinib ndi mankhwala a EGFR TKI a m'badwo wachitatu omwe amaperekedwa pakamwa, omwe ali ndi ufulu wokhala ndi mwiniwake, ovomerezedwa ndi NMPA yaku China pochiza odwala akuluakulu omwe ali ndi khansa ya m'mapapo ya EGFR T790M yomwe yasinthidwa kapena yosakhala yaying'ono (NSCLC). NDA yachiwiri ikuwunikidwanso ndi NMPA pochiza odwala akuluakulu omwe ali ndi NSCLC yodziwika bwino kapena yodziwika bwino yokhala ndi EGFR exon 19 deletions kapena exon 21 L858R mutations.
Mankhwalawa adapambana mu kafukufuku wachipatala wa Gawo 3 wochitidwa m'malo ambiri, mwachisawawa, mopanda maso, komanso molamulidwa poyerekeza mphamvu yake ndi chitetezo cha gefitinib pochiza odwala omwe ali ndi NSCLC yapamwamba kapena yofalikira m'malo omwe ali ndi kusintha kwa EGFR. Ngati mfundo yoyamba yakwaniritsidwa, zotsatira zake zidzaperekedwa pamisonkhano yamaphunziro yomwe ikubwera kapena kufalitsidwa m'magazini amaphunziro.
Chigamulo cholamulira chinathandizidwa ndi deta yochokera ku mayeso ofunikira a gawo la 2b (NCT03502850). Uwu ndi kafukufuku wa gawo la 2b wochitidwa m'zipatala 62 ku People's Republic of China. Odwala omwe ali ndi NSCLC yapamwamba kapena yofalikira m'deralo omwe ali ndi kusintha kwa EGFR T790M komwe kwatsimikizika pakati pa minofu ya chotupa kapena plasma yamagazi omwe adapita patsogolo pambuyo pa zoletsa za EGFR tyrosine kinase za m'badwo woyamba kapena wachiwiri kapena omwe ali ndi kusintha kwa EGFR T790M koyamba adalembedwa.
Kuyambira pa Julayi 16, 2019, mpaka pa Marichi 10, 2021, odwala 301 onse adalembetsa ndipo adayamba kulandira chithandizo cha limertinib. Odwala onse adalowa mu seti yonse yowunikira komanso chitetezo. Pofika tsiku lomaliza la deta pa Seputembala 9, 2021, 76 (25.2%) adapitilizabe kulandira chithandizo. Nthawi yowunikira yapakati inali miyezi 10.4. Potengera seti yonse yowunikira, komiti yodziyimira payokha yowunikira ORR inali 68.8% ndipo chiwopsezo chowongolera matenda chinali 92.4%. PFS yapakati inali miyezi 11.0, DoR yapakati inali miyezi 11.1, ndipo OS yapakati sinafike. Mayankho ofunikira adakwaniritsidwa m'magulu onse ang'onoang'ono omwe adasankhidwa kale. Kwa odwala 99 (32.9%) omwe ali ndi matenda a CNS (metastasis), ORR inali 64.6%, PFS yapakati inali miyezi 9.7 (95% CI: 5.9–11.6), ndipo DoR yapakati inali miyezi 9.6. Kwa odwala 41 omwe anali ndi vuto la CNS lodziwika bwino, CNS-ORR yotsimikizika inali 56.1% ndipo CNS-PFS yapakati inali miyezi 10.6.
Pa chitetezo, odwala 289 (96.0%) adakumana ndi vuto limodzi losachepera limodzi lokhudzana ndi chithandizo (TRAE), lomwe lofala kwambiri linali kutsegula m'mimba (81.7%), kuchepa kwa magazi m'thupi (32.6%), ziphuphu (29.9%), ndi anorexia (28.2%). TRAEs za Giredi ≥3 zidachitika mwa odwala 104 (34.6%), ndipo zofala kwambiri zidaphatikizapo kutsegula m'mimba (13.0%), hypokalemia (4.3%), kuchepa kwa magazi m'thupi (4.0%), ndi ziphuphu (3.3%). TRAEs zomwe zidapangitsa kuti mlingo usiye kuperekedwa ndi kusiya kugwiritsidwa ntchito kwa mankhwalawa zidachitika mwa odwala 24.6% ndi 2% motsatana. Palibe TRAE yomwe idapangitsa kuti munthu afe.
Mapeto
Limertinib (ASK120067) inapezeka kuti ili ndi mphamvu yodalirika komanso chitetezo chovomerezeka pochiza odwala omwe ali ndi EGFR T790M-mutated NSCLC yapamwamba kapena yofalikira m'deralo.
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.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Zolemba
2.Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) (ask-pharm.com)
4.https://www.jto.org/article/S1556-0864(22)00267-2/fulltext
Nthawi yotumizira: Januwale-21-2025