Maamulka Cuntada iyo Dawooyinka ayaa oggolaaday osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) marka lagu daro kiimoterabiga ku salaysan platinum ee bukaanada qaba kansarka sanbabada unug yar ee aan unug-yarayn ama metastatic (la/mNSCLC) kuwaas oo leh burooyin leh EGFR exon 19 deletions ama exon 21 L858R, sida lagu aqoonsaday tijaabada FDA-ansixisay, Febraayo 16, 2024.
Tijaabada waxaa lagu sameeyay FLAURA 2 (NCT04035486), oo ah random, sumad furan oo lala yeeshay 557 qof kuwaas oo lahaa EGFR exon 19 tirtirka ama exon 21 L858R mutation-positive locally or metastatic non-small cell cancer cancer (NSCLC) aan hore loo helin daawayn nidaamsan oo jirro sare leh. Bukaannada ayaa si aan kala sooc lahayn loogu qoondeeyay saamiga 1:1 si ay u helaan osimertinib iyo kiimiko ku salaysan platinum ama osimertinib oo keliya.
Qiyaasta waxtarka aasaasiga ah waxay ahayd badbaadada-horumar la'aanta (PFS), oo uu qiimeeyay baaruhu, oo leh guud ahaan badbaadada (OS) oo ah cabbir labaad oo muhiim ah. Markii osimertinib lagu daray kiimoterabiga ku salaysan platinum, badbaadada-horumar la'aanta (PFS) aad bay uga sarraysay markii osimertinib keligiis la isticmaalay. Saamiga khatarta ah wuxuu ahaa 0.62 (95% CI: 0.49-0.79; p-qiimaha laba-dhinac <0.0001). Badbaadada xorta ah ee dhexdhexaadka ah (PFS) waxay ahayd 25.5 bilood oo leh 95% kalsoonida (CI) ee 24.7 si aan loo qiyaasi karin (NE) hal gacan, iyo 16.7 bilood oo leh 95% CI ee 14.1 ilaa 21.3 ee gacanta kale.
Inkasta oo tirakoobka guud ee badbaadada aan si buuxda loo horumarin marka la eego falanqaynta hadda jirta, iyada oo 45% kaliya ee dhimashada hore loo cayimay lagu soo sheegay falanqaynta kama dambaysta ah, ma jirin calaamad muujinaysa isbeddel xun.
Leukopenia, thrombocytopenia, neutropenia, lymfopenia, finan, shuban, stomatitis, dhaawac cidiyaha, maqaarka qalalan, iyo heerarka creatinine ee dhiigga oo sarreeya waxay ahaayeen qaar ka mid ah dhibaatooyinka soo raaca ee ugu badan ee ku dhaca dadka la siiyay osimertinib oo ay weheliso kiimiko ku salaysan platinum.
Qiyaasta osimertinib ee la soo jeediyay waa 80 mg oo afka laga qaato hal mar maalintii, cunto la'aan ama la'aanteed, ilaa cudurku ka sii socdo ama sunta aan la aqbali karin. Kala tasho macluumaadka dawada ee pemetrexed leh cisplatin ama carboplatin faahfaahinta qiyaasta gaarka ah.
Myeloma
NMPA waxay ansixisay zevorcabtagene autoleucel CAR T daawaynta unugyada ee R/R Multi myeloma
Daaweynta Zevor-Cel Nidaamiyeyaasha Shiinaha ayaa ansixiyay zevorcabtagene autoleucel (zevor-cel; CT053), daawaynta unugyada CAR T-cell, oo loogu talagalay daaweynta bukaanka qaangaarka ah ee leh myeloma badan
Susan Hau
Waxaa laga yaabaa 8, 2024
