Osimertinib tare da chemotherapy an amince da su ta USFDA don EGFR-mutated non-saramin cell cancer.

Hukumar Abinci da Magunguna ta amince osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) a hade tare da maganin chemotherapy na tushen platinum ga marasa lafiya da ke da ci gaba a cikin gida ko ƙananan ciwon huhu marasa ƙananan ƙwayoyin cuta (la/mNSCLC) waɗanda ke da ciwace-ciwace tare da gogewar EGFR exon 19 ko maye gurbi na 21 L858R, kamar yadda gwajin da FDA ta amince da shi, ranar Fabrairu 16 ga Nuwamba, 2024.

An yi gwajin ne a cikin FLAURA 2 (NCT04035486), binciken bazuwar, buɗaɗɗen lakabi tare da mutane 557 waɗanda suka sami ko dai EGFR exon 19 gogewa ko exon 21 L858R maye gurbi-tabbatacce a cikin gida ko kuma ciwon daji mara ƙananan ƙwayoyin cuta (NSCLC) ba a da wani tsarin magani don ci gaba da rashin lafiya a da. An ba marasa lafiya ba da gangan ba a cikin rabo na 1:1 don karɓar ko dai osimertinib tare da chemotherapy na tushen platinum ko osimertinib kadai.

Ma'aunin inganci na farko shine tsira ba tare da ci gaba ba (PFS), wanda mai binciken ya kimanta, tare da rayuwa gabaɗaya (OS) a matsayin ma'aunin sakandare mai mahimmanci. Lokacin da aka haɗa osimertinib tare da maganin chemotherapy na tushen platinum, rayuwa marar ci gaba (PFS) ya fi yadda aka yi amfani da osimertinib shi kaɗai. Matsakaicin haɗari shine 0.62 (95% CI: 0.49-0.79; p-darajar mai gefe biyu <0.0001). Matsakaicin ci gaba-free rayuwa (PFS) ya kasance watanni 25.5 tare da tazarar amincewa ta 95% (CI) na 24.7 don ba za a iya ƙididdige shi ba (NE) a hannu ɗaya, da watanni 16.7 tare da 95% CI na 14.1 zuwa 21.3 a ɗayan hannun.

Ko da yake ba a cika kididdigar rayuwa gabaɗaya ba a cikin bincike na yanzu, tare da kawai 45% na adadin mutuwar da aka ƙayyade don bincike na ƙarshe, babu wata alama ta wani mummunan yanayi.

Leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, zawo, stomatitis, ƙusa lalacewa, bushe fata, da kuma hawan jini matakan creatinine wasu daga cikin mafi yawan sakamako masu illa da suka faru ga mutanen da aka ba osimertinib tare da platinum na tushen chemotherapy.

Maganin osimertinib da aka ba da shawarar shine MG 80 ana sha da baki sau ɗaya a rana, tare da ko ba tare da abinci ba, har sai cutar ta ci gaba ko kuma rashin karɓuwa. Tuntuɓi bayanan rubutawa don pemetrexed tare da cisplatin ko carboplatin don takamaiman bayanin kashi.