Tepotinib waxa ay USFDA u ansixisay kansarka sambabada ee unugyada aan yarayn

Maamulka Cuntada iyo Dawooyinka ayaa si rasmi ah u ansixiyay tepotinib (Tepmetko, EMD Serono, Inc.) Febraayo 15, 2024, bukaannada qaangaarka ah ee qaba kansarka sambabada unugyada unugyada yaryar .

Tepotinib waxa uu helay fasax degdeg ah isticmaalkan Feebarwari 3, 2021, ka dib markii uu muujiyay natiijooyin wax ku ool ah tijaabada VISION (NCT02864992), kaas oo ahaa xarun-badan, aan kala sooc lahayn, calaamad furan, cilmi-baaris kooxeedyo badan. U gudubka ansixinta caadiga ah ayaa la sameeyay ka dib markii lagu daray 161 bukaan oo dheeraad ah iyo kordhinta muddada dabagalka bilaha 28 si loo qiimeeyo muddada jawaabta.

Effectiveness was proven in 313 individuals with metastatic kansarka sanbabada ee aan yareyn (NSCLC) carrying MET exon skipping mutations. Patients were administered a daily dose of 450 mg of tepotinib until disease progression or unacceptable toxicity occurred.

Shuruudaha waxtarka leh ee ugu muhiimsan waxay ahaayeen Heerka Jawaabta Ujeeddada (ORR) iyo Muddada Jawaabta (DOR), oo ay qiimeeyeen Guddiga Dib-u-eegista Madax-bannaan ee Indho-la'aanta ah. 164 ka mid ah bukaanada aan hore loo daawayn, Heerka Jawaabta Ujeeddada (ORR) waxa ay ahayd 57% oo leh 95% Kalsoonida Dhexdhexaadinta (CI) ee 49 ilaa 65. Jawaab bixiyaasha ka mid ah, 40% waxay lahaayeen Mudada Jawaabta (DOR) ee 12 bilood ama ka badan. Marka loo eego 149 bukaan ee hore loo daaweeyay, Heerka Jawaabta Ujeeddada (ORR) waxay ahayd 45% iyadoo leh 95% Dhexdhexaadinta Kalsoonida (CI) ee 37 ilaa 53. Intaa waxaa dheer, 36% jawaab bixiyaasha waxay heleen Muddada Jawaabta (DOR) ee 12 bilood ama ka badan.

Saamaynta xun ee ugu badan (≥20%) waxaa ka mid ah barar, lallabbo, daal, muruq xanuun, shuban, dyspnea, rabitaanka cuntada oo yaraada, iyo finan.

Qiyaasta la soo jeediyay ee tepotinib waa 450 mg oo afka laga qaato hal mar maalintii oo cunto ah.

U fiirso macluumaadka qoritaanka oo buuxa ee Tepmetko.