August 2021: Iyo FDA yakabvumidza cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) yekurapa-mutsara kwevarwere vane advanced isiri-diki cell cancer cancer (NSCLC) (yenzvimbo yepamusoro avo vasiri kukwikwidza kuvhiyiwa resection kana definitive chemoradiation kana metastatic) vane mapundu ane yakakwira PD-L1 kutaura (Tumor Proportion Score [TPS]> 50 muzana) ane mapundu ane yakakwira PD-L
Chidzidzo 1624 (NCT03088540), muyedzo wakawanda, wakasarudzika, wakavhurika-label muvarwere ve710 vane NSCLC yenzvimbo yepamusoro avo vaive vasina kukwikwidza kuvhiyiwa kuvhiyiwa kana kujekesa chemoradiation, kana ne metastatic NSCLC, yakaitwa kuti iongorore kushanda. Varwere vakapiwa cemiplimab-rwlc 350 mg intravenously mavhiki ose e3 kusvika kumavhiki e108 kana platinum-based chemotherapy. Nekupofumadzwa kwakazvimirira kwepakati ongororo, iwo makuru ekuita mhedzisiro matanho aive kupona kwese (OS) uye kufambira mberi-kusina kupona (PFS) (BICR).
Varwere vakagamuchira cemiplimab-rwlc vaive nekuwedzera kwakakosha muOS uye PFS kana vachienzaniswa nevaya vakagamuchira platinum-based chemotherapy. Varwere vari cemiplimab-rwlc boka vaive neyakaenzana OS yemwedzi 22.1 (95 muzana CI: 17.7, NE), zvichienzaniswa nemwedzi 14.3 (95 muzana CI: 11.7, 19.2) mune chemotherapy ruoko (HR 0.68; 95 muzana CI: 0.53 , 0.87, p = 0.0022). Iyo cemiplimab-rwlc ruoko yaive neyakaenzana PFS yemwedzi 6.2 (4.5, 8.3) uye chemotherapy ruoko yaive neyakaenzana PFS yemwedzi 5.6 (4.5, 6.1) (HR 0.59; 95 muzana CI: 0.49, 0.72, p0.0001). Mune cemiplimab-rwlc uye chemotherapy mapoka, yakasimbiswa yakazara mhinduro (ORR) paBICR yaive 37 muzana (95 muzana CI: 32, 42) uye 21 muzana (95 muzana CI: 17, 25), zvichiteerana.
Musculoskeletal kusagadzikana, kuputika, kupererwa neropa, kupera simba, kushomeka kwekuda kudya, mabayo, uye kukosora ndizvo zviitiko zvakashata zvakanyanya (> 10%) necemiplimab-rlwc semushonga mumwechete muChidzidzo 1624.
Iyo yakatemwa dhizaini yecemiplimab-rwlc yeNSCLC kurapwa ndeye 350 mg vhiki nhatu dzese, inoiswa mukati mehusimbe kupfuura maminetsi makumi matatu.
Referensi: https://www.fda.gov/
Tarisa uone pano.
