I-Repotrectinib igunyazwe yi-USFDA yomdlavuza wamaphaphu ongewona omncane we-ROS1-positive

I-Food and Drug Administration igunyaze i-repotrectinib (i-Augtyro, i-Bristol-Myers Squibb Company) yomdlavuza wamaphaphu wamaphaphu othuthukile wasendaweni noma we-metastatic i-ROS1-positive non-small cell lung (NSCLC) ngoNovemba 15, 2023.

Lokhu kugunyazwa kwe-FDA ngeyokuqala ukufaka iziguli ezine-ROS1-positive NSCLC ezike zelashwa ngaphambilini nge-ROS1 tyrosine kinase inhibitor (TKI), kanye nabantu abangazange bathole ukwelashwa kwe-TKI ngaphambilini.

The approval was granted following the TRIDENT-1 clinical trial (NCT03093116), a global study including many centers, with a single-arm, open-label design, and various patient cohorts with ROS1-positive locally progressed or metastatic NSCLC. The effectiveness was assessed in 71 ROS1 TKI-naïve patients who had undergone a maximum of 1 previous line of platinum-based chemotherapy and/or immunotherapy, and in 56 patients who had received 1 previous ROS1 TKI without prior platinum-based chemotherapy or immunotherapy.

Izinyathelo eziyinhloko zokusebenza kahle kwakuyizinga lokuphendula eliphelele (ORR) kanye nobude besikhathi sokuphendula (DOR) ngokusekelwe ku-RECIST v1.1 njengoba kuhlolwe isibuyekezo esimaphakathi esingachemile. Izinga Lokusabela Kwenjongo Eqinisekisiwe (ORR) lalingu-79% (95% CI: 68, 88) eqenjini leziguli ezazingazange zithole ukwelashwa nge-ROS1 TKI ngaphambili, kanye nama-38% (95% CI: 25, 52) ezigulini ezingazange zithole ukwelashwa nge-ROS1 TKI. wayethole ukwelashwa kwangaphambili nge-ROS34.1 inhibitor. Isikhathi esimaphakathi sokuphendula kwakuyizinyanga ze-95 (25.6% CI: 14.8, hhayi ukulinganisa) kanye nezinyanga ze-95 (7.6% CI: XNUMX, hhayi ukulinganisa) kumaqembu amabili, ngokulandelana. Ukubhekwa kwenziwa ezilonda zobuchopho zeziguli ezine-metastase yesistimu yezinzwa ezilinganiselwe, kanye nakubantu abanokuguqulwa kokumelana ngemuva kokwelashwa kwe-tyrosine kinase inhibitor.

Izimpendulo ezivame kakhulu ezingezinhle, ezenzeka ezimweni ezingaphezu kuka-20%, kwakuyisiyezi, i-dysgeusia, i-peripheral neuropathy, ukuqunjelwa, i-dyspnea, i-ataxia, ukukhathala, izinkinga zengqondo, nobuthakathaka bemisipha.

Umthamo ophakanyisiwe we-repotrectinib ngu-160 mg othathwa ngomlomo kanye ngosuku, ngokudla noma ngaphandle kokudla, izinsuku eziyi-14. Ngemuva kwalokho, umthamo kufanele unyuswe ube ngu-160 mg othathwe kabili ngosuku kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki.