Chikafu neDrug Administration zvakabvumidzwa osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) musanganiswa neplatinum-based chemotherapy yevarwere vane yemuno yakakwira kana metastatic isiri diki cell cancer cancer (la/mNSCLC) vane mamota ane EGFR exon 19 kubviswa kana exon 21 L858R shanduko, sezvakaonekwa neFDA-yakatenderwa bvunzo, muna Kukadzi. 16, 2024.
Muedzo uyu wakaitwa muFLAURA 2 (NCT04035486), chidzidzo chisina kujairika, chakavhurika-chinyorwa chine vanhu mazana mashanu nemakumi mashanu nevanomwe vaive neEGFR exon 557 deletion kana exon 19 L21R mutation-positive munharaunda yepamusoro kana metastatic isiri diki cell kenza yemapapu (NSCLC) uye vaive ndisina kana systemic kurapwa kwehurwere hwepamusoro kare. Varwere vakagoverwa muchikamu che858: 1 kuti vagamuchire osimertinib pamwe neplatinum-based chemotherapy kana osimertinib chete.
Chiyero chekutanga chekubudirira kwaive kufambira mberi-kusina kupona (PFS), yakaongororwa nemuongorori, nekupona kwese (OS) seyechipiri yakakosha chiyero. Apo osimertinib yakasanganiswa neplatinum-based chemotherapy, kufambira mberi-kusina kupona (PFS) kwakanga kwakakwirira kudarika apo osimertinib yakashandiswa yoga. Huwandu hwengozi hwaive 0.62 (95% CI: 0.49–0.79; mativi maviri p-value <0.0001). Kupona kwepakati-pasina kurarama (PFS) kwaive nemwedzi ye25.5 ine 95% yenguva yekuvimba (CI) ye24.7 kusvika isingafungidzike (NE) mune rumwe ruoko, uye 16.7 mwedzi ine 95% CI ye14.1 kusvika 21.3 mune rumwe ruoko.
Kunyange zvazvo huwandu hwehuwandu hwekupona hwakanga husina kunyatsogadzirwa pakuongorora kwemazuva ano, ne 45% chete yekufa kwakagara kwataurwa kwakashumwa kuongororwa kwekupedzisira, pakanga pasina chiratidzo chemaitiro asina kunaka.
Leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, manyoka, stomatitis, kukuvadzwa kwembambo, ganda rakaoma, uye mazinga epamusoro eropa re creatinine ndiwo mamwe emigumisiro yakajairika yakaitika kune vanhu vakapiwa osimertinib pamwe chete neplatinum-based chemotherapy.
Iyo yakakurudzirwa osimertinib dosage ndeye 80 mg inotorwa nemuromo kamwe chete pazuva, ine kana pasina chikafu, kusvika chirwere chinowedzera kana huturu husingagamuchirwi. Bvunza ruzivo rwekuraira rwepemetrexed necisplatin kana carboplatin yeruzivo rwedosi chaiyo.
Myeloma
NMPA inobvumidza zevorcabtagene autoleucel CAR T Cell kurapwa kweR/R akawanda myeloma
Zevor-Cel therapy Chinese regulators yakabvumidza zevorcabtagene autoleucel (zevor-cel; CT053), autologous CAR T-cell therapy, yekurapa varwere vakuru vane akawanda myeloma iyo.
Susan Hau
Dai 8, 2024
