Tepotinib inotenderwa neUSFDA kune metastatic isiri-diki cell cancer cancer

Chikafu neDrug Administration yakabvumidza zviri pamutemo tepotinib (Tepmetko, EMD Serono, Inc.) muna Kukadzi 15, 2024, yevarwere vakuru vane metastatic isiri diki cell cancer cancer (NSCLC) yaive mesenchymal-epithelial transition (MET) exon 14 kusvetuka shanduko. .

Tepotinib yakagamuchira yakakurumidza kubvumidzwa kushandiswa uku muna Kukadzi 3, 2021, mushure mekuratidza mhedzisiro muyedzo yeVISION (NCT02864992), yaive yakawanda, isina-randomized, yakavhurika-label, multicohort research. Kuchinja kune kubvumirwa kwakajairika kwakaitwa mushure mekubatanidza 161 vamwe varwere uye kuwedzera nguva yekutevera nemwedzi ye28 kuti iongorore nguva yekupindura.

Kubudirira kwakaratidzwa mu313 vanhu vane metastatic isina-diki kenza yemapapu kenza (NSCLC) inotakura MET exon kusvetuka shanduko. Varwere vaipiwa zuva rega rega re 450 mg ye tepotinib kusvikira kufambira mberi kwechirwere kana kutyisa kusingagamuchirwi kwakaitika.

Nzira huru yekubudirira yaive Chinangwa Response Rate (ORR) uye Nguva Yekupindura (DOR), yakaongororwa neBlinded Independent Review Committee. Kunze kwevarwere ve164 vakanga vasina kurapwa kare, Objective Response Rate (ORR) yaiva 57% ine 95% Confidence Interval (CI) ye49 kusvika ku65. Pakati pevakapindura, 40% yakanga ine Duration of Response (DOR) ye Mwedzi 12 kana kupfuura. Kunze kwevarwere ve149 vakanga vagamuchira kurapwa kare, Chinangwa Response Rate (ORR) chaiva 45% ne95% Confidence Interval (CI) ye37 kusvika ku53. Uyezve, 36% yevakapindura vaiva neDuration of Response (DOR) ye Mwedzi 12 kana kupfuura.

Migumisiro yakaipisisa (≥20%) yaisanganisira edema, kusvotwa, kuneta, kurwadziwa kwetsandanyama, manyoka, dyspnea, kuderera kwechido, uye kuputika.

Chiyero chinokurudzirwa chetepotinib i450 mg inotorwa nemuromo kamwe pazuva nekudya.

Wona ruzivo rwakazara rwekurayira Tepmetko.