August 2023: Pralsetinib (Gavreto, Genentech, Inc.) yakapihwa mvumo nguva dzose neFood and Drug Administration kuvarwere vakuru vane metastatic RET fusion-positive isiri diki cell lung cancer (NSCLC), sekutemerwa neFDA-yakatenderwa bvunzo.
Kubva pachiyero chekutanga chekupindura (ORR) uye kusimba kwekupindura (DOR) muvarwere ve114 vari kutora chikamu muchirongwa cheARROW (NCT03037385), multicenter, open-label, multi-cohort trial, pralsetinib yakambopiwa mvumo yakakurumidza yeNSCLC. chiratidzo cheSept. 4, 2020. Kubva pane ruzivo kubva kune 123 vamwe varwere uye imwezve mwedzi ye25 yekutevera kuti ione hupenyu hurefu hwemhinduro, kutendeuka kune kubvumirwa nguva dzose kwakaitwa.
Huwandu hwevarwere mazana maviri nemakumi matatu nevanomwe vane kufambira mberi munharaunda kana metastatic RET fusion-positive NSCLC vakaratidza kushanda. Varwere vakapiwa pralsetinib kusvikira chirwere chacho chawedzera kana kuti migumisiro isingagoneki.
A Bofu Rakazvimiririra Ongororo Komiti (BIRC) yakafunga kuti ORR neDOR ndiwo akakosha matanho ekuita. IORR yaiva 78% (95% CI: 68, 85) pakati pevarwere ve107 vakanga vasati vambowana kurapwa, uye DOR yepakati yaiva mwedzi 13.4 (95% CI: 9.4, 23.1). IORR yaiva 63% (95% CI: 54, 71) pakati pevarwere ve130 vakanga vambove neplatinum-based chemotherapy, uye yepakati DOR yaiva 38.8 mwedzi (95% CI: 14.8, isingaenzaniswi).
Musculoskeletal kusagadzikana, kuvimbiswa, hypertension, manyoka, kuneta, edoema, pyrexia, uye kukosora ndizvo zvaiwanzoitika (25%).
400 mg yepralsetinib inotorwa nemuromo kamwe chete pazuva ndiyo inokurudzirwa dosage. Inokurudzirwa kutora pralsetinib padumbu risina chinhu (pasina chikafu kwemaawa maviri asati asvika uye kanenge 2 awa inotevera kutungamirirwa kwepralsetinib).
