USFDA ta amince da Tepotinib don ciwon huhu mara ƙananan ƙwayar cuta

Hukumar Abinci da Magunguna a hukumance ta amince da tepotinib (Tepmetko, EMD Serono, Inc.) a ranar 15 ga Fabrairu, 2024, don manya marasa lafiya waɗanda ke da cutar kansar huhun huhun da ba ta ƙanƙanta ba (NSCLC) waɗanda ke da canjin mesenchymal-epithelial (MET) exon 14 tsallake maye gurbi. .

Tepotinib ya sami ƙarin izini don wannan amfani a ranar 3 ga Fabrairu, 2021, bayan nuna sakamako mai kyau a cikin gwajin VISION (NCT02864992), wanda ya kasance babban ci gaba, wanda ba bazuwar, buɗaɗɗen lakabin, bincike na multicohort. An canza canjin zuwa yarda na al'ada bayan haɗawa da ƙarin marasa lafiya na 161 da kuma tsawaita lokacin bibiyar ta watanni 28 don kimanta tsawon lokacin amsawa.

Effectiveness was proven in 313 individuals with metastatic cututtukan daji na kansa marasa kansar (NSCLC) carrying MET exon skipping mutations. Patients were administered a daily dose of 450 mg of tepotinib until disease progression or unacceptable toxicity occurred.

Babban ma'auni na tasiri sune Maƙasudin Amsa Rate (ORR) da Tsawon Lokacin Amsa (DOR), wanda Kwamitin Bincike mai zaman kansa na Makafi ya tantance. Daga cikin marasa lafiya 164 da ba su da magani a baya, Maƙasudin Amsa (ORR) shine 57% tare da 95% Amintaccen Tsakanin (CI) na 49 zuwa 65. Daga cikin masu amsawa, 40% yana da Tsawon Lokacin Amsa (DOR) na Watanni 12 ko fiye. Daga cikin marasa lafiya 149 da suka karɓi magani a baya, Maƙasudin Amsa Rate (ORR) shine 45% tare da 95% Tazarar Amincewa (CI) na 37 zuwa 53. Bugu da ƙari, 36% na masu amsawa suna da Duration of Response (DOR) na Watanni 12 ko fiye.

Abubuwan da suka fi dacewa (≥20%) sun haɗa da edema, tashin zuciya, gajiya, ciwon tsoka, zawo, dyspnea, rage cin abinci, da kurji.

Adadin da aka ba da shawarar na tepotinib shine 450 MG ana sha ta baki sau ɗaya a rana tare da abinci.

Duba cikakken bayanin rubutawa don Tepmetko.