FDA Pom Zoo Atezolizumab Ntxiv Chemotherapy rau Stage III dMMR Colon Cancer, Txo Ib Nrab Disease-Free Survival Kev Pheej Hmoo
US Food and Drug Administration hnub October 8 pom zoo atezolizumab (Tecentriq, Genentech) ua ke nrog fluoropyrimidine thiab oxaliplatin rau kev kho adjuvant ntawm cov neeg laus thiab cov menyuam hnub nyoog 2 xyoo thiab laus dua nrog Stage III mismatch repair-deficient (dMMR) colon cancer. Qhov subcutaneous formulation, atezolizumab thiab hyaluronidase-tqjs (Tecentriq Hybreza), raug pom zoo nrog tib chemotherapy rau cov neeg mob hnub nyoog 12 xyoo thiab laus dua hnyav tsawg kawg 40 kg.
Qhov kev pom zoo nyob ntawm ATOMIC/ML39057 kev sim, uas 711 tus laus thiab ib tug menyuam uas tau phais tag nrho raug xaiv 1:1 rau atezolizumab ntxiv 12 zaug ntawm mFOLFOX6 tom qab ntawd rau lub hlis ntawm atezolizumab ib leeg, los yog 12 zaug ntawm mFOLFOX6 ib leeg. Qhov txiaj ntsig tseem ceeb, disease-free survival, qhia hazard ratio ntawm 0.50 (95% CI 0.35–0.73; p=0.0001) — txo ib nrab kev pheej hmoo ntawm kev rov tshwm sim los yog tuag — nrog median disease-free survival tsis tau mus txog hauv ob sab caj npab.
FDA daim ntawv ceeb toom nqa cov lus ceeb toom rau immune-mediated adverse reactions, infusion-related reactions, cov teeb meem ntawm stem-cell transplantation thiab embryo-fetal toxicity. Cov qog mismatch repair-deficient yog ntawm cov colon cancers teb zoo tshaj plaws rau immunotherapy, ua rau qhov no yog ib qho ntxiv tseem ceeb rau cov kev xaiv adjuvant; cov kev txiav txim kho nyob ntawm tus neeg mob pab pawg oncology raws li biomarker kev sim.
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 癌组织中的T细胞显微图像。Image: NIH Image Gallery, public domain
