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I-Tepotinib igunyazwe yi-USFDA ngomdlavuza wamaphaphu we-metastatic ongewona omncane

I-Tepotinib igunyazwe yi-USFDA yomdlavuza wamaphaphu we-metastatic, ongewona omncane

Yabelana ngalokhu okuthunyelwe

I-Food and Drug Administration igunyaze ngokusemthethweni i-tepotinib (Tepmetko, EMD Serono, Inc.) ngoFebhuwari 15, 2024, ezigulini zabantu abadala ezinomdlavuza wamaphaphu ongewona omncane we-metastatic (NSCLC) owawunoshintsho lwe-mesenchymal-epithelial transition (MET) exon 14 ukweqa izinguquko. .

I-Tepotinib ithole imvume esheshisiwe yalokhu kusetshenziswa ngoFebhuwari 3, 2021, ngemuva kokubonisa imiphumela emihle esivivinyweni se-VISION (NCT02864992), obekuwucwaningo olugxile ezintweni eziningi, olungahleliwe, oluvulekile, nolwe-multicohort. Ukushintshela ekugunyazweni okuvamile kwenziwa ngemva kokufaka iziguli ezengeziwe ezingu-161 nokwelula isikhathi sokulandelela ngezinyanga ezingu-28 ukuze kuhlolwe isikhathi sokuphendula.

Ukusebenza kwafakazelwa kubantu abangama-313 abane-metastatic umdlavuza wamaphaphu weselula ongewona omncane (NSCLC) ephethe ukuguqulwa kwe-MET exon ukweqa. Iziguli zanikezwa umthamo wansuku zonke we-450 mg we-tepotinib kuze kube yilapho kwenzeka ukukhula kwesifo noma ubuthi obungamukeleki.

Imibandela yokusebenza eyinhloko bekuyi-Objective Response Rate (ORR) kanye Nobude Besikhathi Sempendulo (DOR), ehlolwe yiKomidi Lokubuyekeza Elizimele Elingaboni. Ezigulini eziyi-164 ezazingakaze zithole ukwelashwa ngaphambili, i-Objective Response Rate (ORR) yayingu-57% ne-95% Confidence Interval (CI) yama-49 kuya ku-65. Phakathi kwabaphenduli, ama-40% abe Nesikhathi Sokuphendula (DOR) Izinyanga eziyi-12 noma ngaphezulu. Ezigulini eziyi-149 ezake zithole ukwelashwa ngaphambilini, I-Objective Response Rate (ORR) yayingu-45% ne-95% Confidence Interval (CI) yama-37 kuya ku-53. Ukwengeza, u-36% wabaphenduli babe Nesikhathi Sokuphendula (DOR) Izinyanga eziyi-12 noma ngaphezulu.

Imiphumela emibi evelele (≥20%) yayihlanganisa i-edema, isicanucanu, ukukhathala, ubuhlungu bemisipha namathambo, isifo sohudo, i-dyspnea, ukuncipha kwesifiso sokudla, nokuqubuka.

Umthamo ophakanyisiwe we-tepotinib ngu-450 mg othathwa ngomlomo kanye ngosuku kanye nokudla.

Buka imininingwane egcwele ye-Tepmetko.

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