Ukugunyazwa okusheshayo kunikezwa yi-FDA ku-fam-trastuzumab deruxtecan-nxki yomdlavuza wamaphaphu we-HER2-mutant ongewona omncane.

Yabelana ngalokhu okuthunyelwe

Agasti 2022: Ezigulini ezikhulile ezinomdlavuza we-metastatic non-small cell lung cancer (NSCLC) ezinamathumba anokuguqulwa okuholela ekuguqukeni kwe-mesenchymal-epithelial (MET) exon 14, njengoba kutholwe ukuhlolwa okugunyazwe yi-FDA, i-Food and Drug Administration inikeze i-capmatinib (Tabrecta). , i-Novartis Pharmaceuticals Corp.) imvume evamile.

I-Capmatinib yanikezwa ukugunyazwa okusheshayo kokusetshenziswa okufanayo ngoMeyi 6, 2020, ngokususelwe esilinganisweni esiphelele sokuphendula kanye nobude bempendulo esivivinyweni se-GEOMETRY mono-1 (NCT02414139), ilebula ephakathi nendawo, engahleliwe, evulekile, iqoqo labantu abaningi. ucwaningo locwaningo. Ngokusekelwe kudatha evela ezigulini ezengeziwe ze-63 kanye nezinyanga ezengeziwe ze-22 zokulandelela ukuze kuhlolwe ukuqina kwempendulo nokuqinisekisa inzuzo yokwelapha, ukuguqulwa ekugunyazweni okuvamile kwenziwa.

Iziguli eziyi-160 ezine-NSCLC ethuthukisiwe ene-exon 14 ye-MET yokuguqula ibonise ukusebenza kahle. Iziguli zithole i-capmatinib 400 mg kabili ngosuku kuze kube yilapho isifo sabo siqhubeka noma imiphumela emibi ingabekezeleleki.

IKomidi Lokubuyekeza Elizimele Elingabonisiwe (BIRC) linqume i-ORR kanye nobude besikhathi sokuphendula (DOR) njengezinyathelo ezinkulu zokusebenza (BIRC). Abantu abangu-60 abangakaze bathole ukwelashwa babe ne-ORR engu-68% (95% CI: 55, 80) kanye ne-DOR yezinyanga ezingu-16.6 (95% CI: 8.4, 22.1). I-ORR yayingu-44% (95% CI: 34, 54) phakathi kweziguli eziyi-100 ezazithole ukwelashwa ngaphambilini, kanti i-DOR yayiyizinyanga ezingu-9.7 (95% CI: 5.6, 13).

The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% were white, 61% never smoked, 83% had i-adenocarcinoma, futhi u-16% waba nama-metastases ohlelweni lwezinzwa oluphakathi. I-81% yeziguli ezake zelashwa ngaphambili zazithole umugqa owodwa kuphela we-systemic therapy; 16% bathole amabili; kanti u-3% uthole ezintathu. Ama-86% eziguli ezake zalashwa ngaphambilini zathola i-chemotherapy esekelwe kwi-platinum.

Iziguli zabhekana ne-edema, isicanucanu, ubuhlungu bemisipha namathambo, ukukhathala, ukuhlanza, ukuphefumula kanzima, ukukhwehlela, nokuncipha kwesifiso sokudla izikhathi eziningi (20%).

I-Capmatinib kufanele ithathwe ngomlomo kabili ngosuku ngethamo lama-400 mg, ngokudla noma ngaphandle kokudla.

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