Roche Gavreto (pralsetinib) Yuav Tsum Tau Pom Zoo hauv EU: Kev Kho Mob RET Fusion-positive Lung Cancer--1/2

Roche tsis ntev los no tau tshaj tawm tias European Medicines Agency (EMA) Pawg Neeg Saib Xyuas Kev Kho Mob rau Tib Neeg Siv (CHMP) tau tshaj tawm qhov kev tshuaj xyuas zoo qhia txog kev pom zoo ntawm qhov tseeb oncology tshuaj-RET kinase inhibitor Gavreto (pralsetinib), raws li Monotherapy yog siv los kho cov neeg laus nrog RET fusion-positive advanced non-small cell lung cancer (NSCLC) uas tsis tau kho yav dhau los nrog RET inhibitors.

Tam sim no, CHMP cov kev xav yuav raug xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas feem ntau ua rau kev txiav txim siab zaum kawg hauv 2 lub hlis. Yog tias pom zoo, Gavreto yuav dhau los ua thawj thiab tsuas yog cov tshuaj tsom mus rau suav nrog hauv thawj kab kev kho mob ntawm RET fusion-zoo tshaj NSCLC hauv EU. Cov kev xav zoo ntawm CHMP, raws li cov txiaj ntsig ntawm Phase I / II ARROW txoj kev tshawb fawb, cov ntaub ntawv qhia tias Gavreto qhia tau hais tias sai, muaj zog, thiab ruaj khov cov lus teb rau cov neeg mob nrog RET fusion-zoo NSCLC.

Gavreto yog qhov ncauj, ib zaug ib hnub, muaj zog thiab xaiv RET inhibitor tsim thiab tsim los ntawm Blueprint Medicines los tiv thaiv kev hloov pauv RET (fusions thiab kev hloov pauv, suav nrog kev kwv yees tshuaj tiv thaiv kev hloov pauv) uas ua rau ntau yam mob qog noj ntshav. Gavreto tau qhia txog kev ua tau zoo hauv kev kho mob ntawm ntau hom qog nqaij hlav, qhia txog lub peev xwm ntawm qog-agnostic.

Levi Garraway, MD, Roche Tus Thawj Saib Xyuas Kev Kho Mob thiab Tus Thawj Coj ntawm Kev Txhim Kho Cov Khoom Ntiaj Teb, tau hais tias: "CHMP qhov kev ntsuam xyuas zoo ntawm Gavreto sawv cev rau lwm kauj ruam ntawm kev muab kev kho mob zoo rau cov neeg mob qog noj ntshav ntau npaum li sai tau rau cov kab mob gene tsav. Ib kauj ruam tseem ceeb. Kev nce qib hauv cov tshuaj kho tus kheej kuj tseem hais txog qhov tseem ceeb ntawm cov qog nqaij hlav genome txhawm rau txheeb xyuas cov neeg mob uas yuav tau txais txiaj ntsig los ntawm kev kho mob."

RET-activated fusions thiab kev hloov pauv yog cov kab mob tseem ceeb rau ntau hom mob qog noj ntshav, suav nrog NSCLC thiab MTC. RET fusion cuam tshuam txog li 1-2% ntawm cov neeg mob NSCLC, txog 10-20% ntawm cov neeg mob uas muaj papillary thyroid carcinoma (PTC), thiab RET hloov pauv muaj txog li 90% ntawm cov neeg mob uas muaj MTC siab heev. Tsis tas li ntawd, kev hloov pauv RET tsawg zaus kuj tau pom nyob rau hauv mob qog noj ntshav, mob qog noj ntshav mis, mob qog noj ntshav thiab lwm yam qog noj ntshav, thiab RET fusion kuj tau pom nyob rau hauv cov neeg mob uas muaj tshuaj tiv thaiv, EGFR-mutated NSCLC.

pralsetinibtau tsim los ntawm pab pawg tshawb fawb ntawm Blueprint Medicines raws li nws lub tsev qiv ntawv muaj tswv yim. Hauv kev tshawb fawb preclinical, pralsetinib ib txwm pom cov kab mob me me ntawm nanomolar titers tawm tsam cov RET gene fusions feem ntau, ua kom muaj kev hloov pauv, thiab kev hloov tshuaj tiv thaiv. Tsis tas li ntawd, lub selectivity ntawmpralsetinibrau RET yog qhov zoo dua qub piv nrog kev pom zoo multi-kinase inhibitors. Ntawm lawv, qhov ua tau zoo ntawm pralsetinib yog ntau dua 90-fold siab dua li ntawm VEGFR2. Los ntawm inhibiting thawj thiab theem nrab mutations,pralsetinibcia siab tias yuav kov yeej thiab tiv thaiv qhov tshwm sim ntawm kev kho tshuaj tiv thaiv. Txoj kev kho no yuav tsum ua kom tiav kev kho mob mus ntev rau cov neeg mob uas muaj RET sib txawv, thiab muaj kev nyab xeeb zoo.