Tebchaws Asmeskas FDA Pom Zoo Darzalex Faspro: Ua ke Pomalidomide + Dexamethasone Rau Kev Kho Mob Ntau Yam Myeloma (MM)!

Janssen Pharmaceuticals, koom nrog Johnson& Johnson (JNJ), tsis ntev los no tshaj tawm tias Asmeskas Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau pom zoo rau subcutaneous (SC) tsim ntawm daratumumab-Darzalex Faspro (daratumumab thiab hyaluronidase-fihj), Ua ke nrog pomalidomide thiab dexamethasone (D-Pd regimen) rau kev kho mob ntawm cov neeg laus uas muaj ntau yam mob myeloma (MM), tshwj xeeb: tau txais yam tsawg kawg ib txoj kev kho yav dhau los (suav nrog lenalidomide thiab A proteasome inhibitor therapy) rau cov neeg mob MM.

Nws tsim nyog hais tias Darzalex Faspro yog thawj zaug thiab tsuas yog txhaj tshuaj subcutaneous ntawm kev tiv thaiv CD38 monoclonal antibody pom zoo thiab siv dav pomalidomide + dexamethasone regimen (Pd regimen) rau kev kho mob ntau yam myeloma. tshuaj. Qhov kev pom zoo no tseem yog qhov qhia thib rau rau Darzalex Faspro hauv kev kho mob ntau yam myeloma (MM). Kev pom zoo yog ua raws cov txiaj ntsig ntawm Phase 3 APOLLO txoj kev kawm. Cov ntaub ntawv cuam tshuam tau tshaj tawm ntawm 2020 American Society of Hematology (ASH) lub rooj sib tham txhua xyoo thiab tau tshaj tawm tsis ntev los no hauv The Lancet Oncology.

Professor Meletios A. Dimopoulos, tus kws tshawb fawb tseem ceeb ntawm APOLLO txoj kev tshawb fawb thiab tus thawj coj ntawm chav saib xyuas kev kho mob ntawm National thiab Kapodistrian University of Athens, tau hais tias:" Kev tshawb fawb soj ntsuam suav nrog APOLLO txuas ntxiv qhia tias nws ua raws daratumumab. Cov phiaj xwm kev kho mob ua ke ntawm lub tuam txhab tuaj yeem txo qhov kev pheej hmoo ntawm kev txhim kho kab mob hauv cov neeg mob uas muaj ntau yam mob myeloma. Nrog qhov kev pom zoo zaum kawg no, tam sim no peb tuaj yeem sib xyaw pomalidomide thiab dexamethasone nrog daratumumab subcutaneous txhaj rau kev kho mob. Qhov kev npaj ua subcutaneous no tuaj yeem tswj hwm hauv ob peb feeb, thaum kev txhaj tshuaj txhaj tshuaj feem ntau siv sijhawm ntau teev."

Hauv kev kho mob ntau yam mob myeloma (MM), txawm hais tias muaj kev txhim kho zoo nyob hauv kaum xyoo dhau los, tus kab mob tseem yog mob qog ntshav ntshav nyuaj, thiab kev tswj hwm cov mob rov qab los yog cov kab mob cuam tshuam yog qhov tshwj xeeb.

Tebchaws Asmeskas FDA' kev pom zoo ntawm D-Pd txoj kev kho rau MM yog ua raws cov ntaub ntawv los ntawm Phase 3 APOLLO txoj kev tshawb fawb (MMY3013). Txoj kev tshawb fawb cuv npe rau 304 tus neeg mob uas tau rov qab los yog rov qab MM uas tau txais tsawg kawg ib txoj kev kho mob yav dhau los, tau txais nallidomide thiab proteasome inhibitor kho, thiab tau lees paub tias muaj kab mob zuj zus. Cov txiaj ntsig tau pom tias piv nrog pomalidomide + dexamethasone regimen (Pd regimen), D-Pd kev tswj hwm txo qis kev pheej hmoo ntawm kev kis mob lossis tuag los ntawm 37% (HR=0.63, p=0.0018). Qhov nruab nrab tsis muaj kev vam meej nyob ruaj khov (PFS) ntawm D-Pd pab pawg thiab Pd pawg yog 12.4 lub hlis thiab 6.9 lub hlis, feem. Ib qho ntxiv, piv nrog pab pawg Pd, pawg D-Pd muaj qhov kev tshem tawm ntau dua, suav nrog: tag nrho cov kev tshem tawm (ORR: 69% vs 46%), ua tiav kev tshem tawm (CR: 25% vs 4%), thiab ntau heev kev zam ib nrab zoo (VGPR) lossis kev zam zoo dua (51% vs 20%), tus kab mob seem tsawg tsawg (9% vs 2%). Kev nyab xeeb ntawm D-Pd cov phiaj xwm zoo ib yam nrog kev paub txog kev nyab xeeb ntawm Darzalex Faspro thiab kev nyab xeeb ntawm Pd cov phiaj xwm.

Hauv Tebchaws Europe, thaum Lub Rau Hli xyoo no, kev txhaj tshuaj subcutaneous (SC) ntawm daratumumab-Darzalex SC (European lub npe kev lag luam, daratumumab thiab hyaluronidase, daratumumab-hyaluronidase) tau pom zoo rau 2 kev tso cai ua lag luam: (1) Darzalex SC ua ke nrog bortezomib, cyclophosphamide, thiab dexamethasone (D-VCd regimen) rau kev kho mob ntawm cov neeg laus uas tau kuaj pom tshiab nrog cov teeb pom kev zoo (AL) amyloidosis; (2) Darzalex SC thiab Poma D-Pd rau kev kho mob ntawm cov neeg laus uas muaj ntau yam mob myeloma (MM), tshwj xeeb: Tau txais cov proteasome inhibitor thiab lenalidomide yav dhau los, thiab Cov neeg mob uas tsis tuaj yeem ua rau lenalidomide, lossis leej twg tau txais yav tas los ntawm yam tsawg 2 txoj kev kho mob uas muaj lenalidomide thiab proteasome inhibitor, thiab leej twg tau nce qib thaum lossis tom qab kev kho zaum kawg.

Darzalex Faspro/Darzalex SC tau siv nyob rau hauv ib koob tshuaj los ntawm kev txhaj tshuaj subcutaneous, uas tsuas yog siv sijhawm 3-5 feeb los ua kom tiav. Kev npaj tshuaj Darzalex intravenous (IV) raug tswj hwm los ntawm kev tso dej tawm, uas feem ntau siv sijhawm ntau teev.

Nws tsim nyog hais tias Darzalex Faspro/Darzalex SC yog thawj zaug thiab tsuas yog tshuaj pom zoo rau kev kho mob AL amyloidosis hauv Asmeskas thiab European Union. Cov tshuaj no haum rau thawj-kab kev kho mob ntawm cov neeg laus uas tau kuaj pom tshiab nrog AL amyloidosis.