Lorviqua (lorlatinib) Yuav Tsum Tau Pom Zoo hauv EU: Kev Ua Tau Zoo Tshaj Plaws Zoo Tshaj Xalkori!

Pfizer hnub no tau tshaj tawm tias Pawg Neeg Saib Xyuas Kev Kho Mob rau Tib Neeg Siv (CHMP) ntawm European Medicines Agency (EMA) tau tshaj tawm qhov kev tshuaj xyuas zoo pom zoo pom zoo los ntawm Lorviqua (lorlatinib): thawj- kab kev kho mob ntawm anaplastic lymphoma kinase (ALK)-zoo siab tsis zoo- Cov neeg laus uas muaj mob ntsws cancer me me (NSCLC). CHMP cov kev xav yuav raug xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas feem ntau ua qhov kev txiav txim siab zaum kawg hauv 2 lub hlis.

Lub Peb Hlis Ntuj xyoo no,lorlatinibtau txais kev pom zoo los ntawm US FDA kom nthuav dav qhov taw qhia: rau thawj - kab kev kho mob ntawm cov neeg laus nrog ALK- zoo metastatic NSCLC. Cov txiaj ntsig tau los ntawm Theem 3 CROWN kev sim tau pom tias Lorviqua txo qhov kev pheej hmoo ntawm kev kis kab mob lossis tuag los ntawm 72 feem pua ​​​​piv nrog Pfizer thawj zaug - tiam ALK inhibitor Xalkori (crizotinib) hauv cov neeg laus uas tau kuaj pom tshiab ALK- zoo NSCLC .

Mob ntsws cancer yog tus thib ib ua rau mob qog noj ntshav-txog kev tuag thoob ntiaj teb. NSCLC suav txog kwv yees li 80-85 feem pua ​​​​ntawm cov qog nqaij hlav ntsws. ALK- cov qog zoo rau kwv yees li 3-5 feem pua ​​​​ntawm NSCLC cov neeg mob. Ua ntej cov phiaj xwm kev kho mob thiab kev tiv thaiv kab mob, 5-xyoo kev ciaj sia rau cov neeg mob uas muaj NSCLC siab heev tsuas yog 5 feem pua. Xalkori (crizotinib) yog lub ntiaj teb thawj ALK tsom cov tshuaj pib los ntawm Pfizer. Xalkori yog thawj tiam ALK tyrosine kinase inhibitor (TKI). Txij li thaum nws tso tawm xyoo 2011, nws tau hloov pauv qhov kev cia siab ntawm cov neeg mob uas muaj ALK ntxiv rau NSCLC. Kev kho mob.

Lorbrena yog tus thib peb - tiam ALK inhibitor tshwj xeeb tsim los tiv thaiv cov qog nqaij hlav ntau tshaj plaws uas ua rau muaj kev tiv thaiv rau cov tshuaj tam sim no thiab hais txog lub hlwb metastases ntawm qhov chaw uas muaj kab mob loj tshaj plaws hauv ALK-zoo NSCLC. Ntawm cov neeg mob uas muaj ALK- mob qog noj ntshav zoo, txog li 40 feem pua ​​​​ntawm cov neeg mob qog nqaij hlav hauv hlwb thaum kuaj pom thawj zaug.

US FDA qhov kev pom zoo nthuav dav thiab EU CHMP cov lus pom zoo rau kev pom zoo yog raws li cov ntaub ntawv los ntawm qhov tseem ceeb ntawm Kev Kawm Phaj 3 CROWN. Qhov no yog lub taub hau -rau- kev tshawb fawb lub taub hau ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm ob ALK- cov tshuaj tiv thaiv kab mob,lorlatinibthiabcrizotinib, raws li thawj zaug - kab kev kho hauv 296 yav tas los tsis kho cov neeg mob nrog ALK ntxiv rau NSCLC.

Cov ntaub ntawv qhia tau hais tias kev kho mob lorlatinib txo qis kev pheej hmoo ntawm kev kis kab mob lossis tuag los ntawm 72 feem pua ​​​​piv rau crizotinib (HR=0.28, p<0.001). in="" addition,="" in="" patients="" with="" measurable="" brain="" metastases,="">lorlatinibKev kho mob tau zoo txhim kho intracranial teb tus nqi piv nrog crizotinib (lub hom phiaj teb tus nqi ORR: 82 feem pua ​​​​vs 23 feem pua ​​​​; ua tiav cov lus teb CR: 71 feem pua ​​​​vs. 8 feem pua ​​), thiab cov feem pua ​​​​ntawm cov neeg mob intracranial lub sij hawm teb (IC{{4}). }DOR) Ntau dua lossis sib npaug rau 12 lub hlis yog qhov siab dua (79 feem pua ​​​​vs 0 feem pua ​​).

Biomarker-cov tshuaj uas tau tsav tau txhim kho cov txiaj ntsig zoo rau cov neeg mob ALK-NSCLC zoo, tab sis cov kev kho tshiab tseem yuav tsum tau ua kom qeeb tus kab mob. Cov txiaj ntsig ntawm CROWN txoj kev tshawb fawb pom tau tias Lorbrena muaj peev xwm ua thawj zaug - txoj kev kho kab mob uas hloov pauv kev kho mob hauv ALK-NSCLC zoo. Cov ntaub ntawv cuam tshuam tau luam tawm hauv phau ntawv xov xwm kho mob thoob ntiaj teb "New England Journal of Medicine" (NEJM). Saib: Ua ntej-Line Lorlatinib los yog Crizotinib hauv Advanced ALK- Mob ntsws cancer zoo.