US FDA pom zoo Takeda Exkivity: thawj qhov ncauj kev kho mob ntsws cancer nrog EGFR exon 20 insertion mutation!--1/2

Takeda Pharmaceuticals (Takeda) tsis ntev los no tau tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo nws cov tshuaj kho mob ntsws tshiab Exkivity (mobocertinib, TAK-788) rau kev kho tus kab mob kev loj hlob thaum lub sij hawm los yog tom qab yav dhau los platinum-muaj tshuaj chemotherapy, tau pom zoo los ntawm FDA Txoj kev kuaj pom tau lees paub tias yog ib tus neeg laus uas muaj mob qog noj ntshav hauv cheeb tsam lossis metastatic non-small cell lung cancer (mNSCLC) nqa epidermal. Kev loj hlob zoo receptor (EGFR) exon 20 insertion mutation (EGFRex20ins). Qhov kev pom zoo yog nyob ntawm tus nqi teb tag nrho (ORR) thiab lub sijhawm teb (DOR). Tom qab tag nrho cov kev pom zoo rau qhov kev qhia no yuav nyob ntawm qhov kev txheeb xyuas thiab kev piav qhia ntawm cov txiaj ntsig kho mob hauv kev kuaj mob uas tau lees paub.

FDA kuj pom zoo Thermo Fisher Scientific' s Oncomine Dx Target Test raws li NGS tus khub kuaj mob rau kev txheeb xyuas cov neeg mob NSCLC nrog EGFR exon 20 insertion mutations (EGFRex20ins). Kev ntsuam xyuas NGS yog qhov tseem ceeb heev rau cov neeg mob no, vim tias piv nrog kev sim tshuaj polymerase saw tshuaj tiv thaiv (PCR), NGS kuaj tuaj yeem ua tiav qhov kev kuaj pom tseeb dua, thiab kev kuaj pom tus nqi ntawm EGFRex20ins kev hloov pauv los ntawm PCR yog ntau dua 50% qis dua.

Nws yog tsim nyog hais tias Exkivity yog thawj zaug thiab tsuas yog qhov ncauj kho tau pom zoo rau tshwj xeeb thiab xaiv lub hom phiaj EGFRex20ins kev hloov pauv. Exkivity tau pom zoo los ntawm Orbis qhov kev pab cuam (Project Orbis) thiab yav dhau los tau tso cai saib xyuas qhov tseem ceeb, kev xaiv kev kho mob (BTD), kev xaiv ceev ceev (FTD), thiab kev xaiv tshuaj menyuam ntsuag (ODD). Lub Orbis txoj kev npaj lub hom phiaj los muab lub hauv paus rau kev sib koom ua ke thiab kev pom zoo ntawm cov khoom siv oncology rau US FDA thiab nws cov koom haum tswj hwm kev koom tes thoob ntiaj teb, ua kom cov txheej txheem tshuaj xyuas, thiab ua tiav kev pom zoo ib txhij ntawm kev siv tshuaj kho mob qog noj ntshav hauv ntau lub tebchaws.

Exkivity's active pharmaceutical ingredient yogmobocertinib, uas yog ib qho tshiab thiab muaj zog me me molecule tyrosine kinase inhibitor (TKI) tsim los tsom EGFR thiab human epidermal growth factor receptor 2 (HER2) sab nraum No. 20 nrog siab selectivity Insertion mutations. Hauv Tebchaws Meskas thiab Tuam Tshoj, mobocertinib tau tso cai rau kev kho mob (BTD) rau kev kho mob NSCLC cov neeg mob nrog EGFRex20ins kev hloov pauv.

Hauv Suav teb, thaum Lub Xya Hli xyoo no,mobocertinibtau raug lees paub los ntawm Lub Chaw Saib Xyuas Tshuaj Ntsuam Xyuas Tshuaj (CDE) ntawm National Medical Products Administration (NMPA), thiab tau pom zoo kom suav nrog hauv kev tshuaj xyuas ua ntej thiab kev pom zoo. Nws yog npaj los siv rau kev kho mob ntawm cov neeg laus nrog NSCLC nrog EGFRex20ins. EGFR exon 20 insertion (EGFRex20ins) kev hloov pauv yog qhov tsis tshua muaj kev hloov pauv hauv NSCLC. Hauv Suav teb, qhov xwm txheej ntawm EGFRex20ins mutations suav txog kwv yees li 2.3% ntawm tag nrho NSCLCs. Tam sim no tsis muaj cov tshuaj pom zoo rau EGFRex20ins kev hloov pauv.

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