Limertinib wuxuu ku guuleystay Ansixinta Shiinaha ee EGFR T790M+ NSCLC

Janaayo 16, 2025, Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ansixiyay Codsiga Daawada Cusub (NDA) ee limertinib si loogu daaweeyo bukaanada qaangaarka ah ee qaba kansarka sambabada unugyada yaryar ee aan la beddelin ee EGFR T790M (NSCLC) ee maxalliga ah ama horumaray.

Ku saabsan Limertinib

Limertinib waa daawo afka laga qaato oo jiil saddexaad ah oo leh xuquuq gaar ah, oo ay ansixisay NMPA-da Shiinaha si loogu daaweeyo bukaanada qaangaarka ah ee qaba kansarka sambabka ee unugyada yaryar ee aan la beddelin ee EGFR T790M (NSCLC). NDA labaad waxay ku jirtaa dib u eegista NMPA ee daaweynta safka hore ee bukaanada qaangaarka ah ee qaba NSCLC-da maxalliga ah ee horumarsan ama metastatic ah oo sida EGFR exon 19 tirtirid ama isbeddellada exon 21 L858R.

Daawadu waxay muujisay guul tijaabo caafimaad oo heer dhexe ah oo badan, aan kala sooc lahayn, laba-indhoole ah, oo la xakameeyey iyadoo la barbar dhigayo waxtarkeeda iyo badqabkeeda gefitinib ee daaweynta safka hore ee bukaanada qaba NSCLC-ga maxalliga ah ee horumarsan ama metastatic ah oo wata isbeddellada EGFR. Marka la gaaro natiijada ugu horreysa, natiijooyinka waxaa lagu soo bandhigi doonaa shirarka waxbarasho ee soo socda ama lagu daabici doonaa joornaalada tacliinta.

Go'aanka sharciyeynta waxaa taageeray xog laga helay tijaabo muhiim ah oo marxaladda 2b ah (NCT03502850), Tani waa daraasad hal-gacan ah, calaamad furan, oo lagu sameeyay 62 isbitaal oo ku baahsan Jamhuuriyadda Dadka Shiinaha. Bukaannada qaba NSCLC-ga maxalliga ah ee horumarsan ama metastatic ah oo leh isbeddello EGFR T790M oo si dhexe loo xaqiijiyay oo ku jira unugyada burooyinka ama balaasmaha dhiigga kuwaas oo horumaray ka dib markii jiilka koowaad ama labaad ee EGFR tyrosine kinase inhibitors ama isbeddellada aasaasiga ah ee EGFR T790M ayaa la diiwaangeliyey.

Laga bilaabo Luulyo 16, 2019, ilaa Maarso 10, 2021, wadarta guud ee 301 bukaan ayaa la diiwaan geliyay waxayna bilaabeen daaweynta limertinib. Dhammaan bukaanada waxay galeen falanqaynta oo dhammaystiran iyo dejinta badbaadada. Taariikhda go'itaanka xogta Sebtembar 9, 2021, 76 (25.2%) ayaa ku haray daaweynta. Waqtiga dabagalka dhexdhexaadka ah wuxuu ahaa 10.4 bilood. Iyada oo lagu saleynayo falanqaynta oo dhammaystiran, ORR-ka madaxa-bannaan ee guddiga dib-u-eegista uu qiimeeyay wuxuu ahaa 68.8% heerka xakamaynta cudurkuna wuxuu ahaa 92.4%. PFS-ga dhexdhexaadka ah wuxuu ahaa 11.0 bilood, DoR-ka dhexdhexaadka ah wuxuu ahaa 11.1 bilood, OS-ka dhexdhexaadka ahna lama gaarin. Jawaabaha ujeeddada ah ayaa laga gaaray dhammaan kooxaha hoosaadka ah ee la cayimay. 99 bukaan (32.9%) oo qaba metastases-ka habdhiska neerfaha dhexe (CNS), ORR wuxuu ahaa 64.6%, PFS-ga dhexdhexaadka ah wuxuu ahaa 9.7 bilood (95% CI: 5.9–11.6), iyo DoR-ga dhexdhexaadka ah wuxuu ahaa 9.6 bilood. 41 bukaan oo qabay dhaawac CNS ah oo la qiimeyn karo, CNS-ORR-ka la xaqiijiyay wuxuu ahaa 56.1% halka CNS-PFS-ga dhexdhexaadka ah uu ahaa 10.6 bilood.

Xaaladda badbaadada, 289 bukaan (96.0%) waxay la kulmeen ugu yaraan hal dhacdo oo la xiriirta daaweynta (TRAE), kuwa ugu badanna waa shuban (81.7%), dhiig-yaraan (32.6%), finan (29.9%), iyo anorexia (28.2%). Darajada ≥3 TRAEs waxay ka dhacday 104 bukaan (34.6%), kuwa ugu badanna waxaa ka mid ah shuban (13.0%), hypokalemia (4.3%), dhiig-yaraan (4.0%), iyo finan (3.3%). TRAEs oo horseeday joojinta qiyaasta daawada iyo joojinta qiyaasta ayaa ka dhacay 24.6% iyo 2% bukaanada, siday u kala horreeyaan. Ma jirin TRAE oo horseeday dhimasho.

Gunaanad

Limertinib (ASK120067) waxaa la ogaaday inuu leeyahay waxtar rajo leh iyo muuqaal badbaado oo la aqbali karo oo loogu talagalay daaweynta bukaanada qaba NSCLC-ga EGFR T790M-mutated ee maxalliga ah ama aan isbeddelin.

Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.

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Tixraacyada

1.国家药品监督管理局 (nmpa.gov.cn)

2.Shirkadda Daawada ee Jiangsu Aosaikang (ASK Pharm) (ask-pharm.com)

3.Shirkadda Innovent iyo ASK Pharm ayaa si wadajir ah ugu dhawaaqay Ansixinta NMPA ee Limertinib, oo ah daawo jiil saddexaad oo loogu talagalay daaweynta kansarka sambabada (prnewswire.com)

4.https://www.jto.org/article/S1556-0864(22)00267-2/fulltext